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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Announcements of participation in ISPY

https://charts.stocktwits.com/production/original_284042699.png

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

102

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Alan, that chart is illegible for me and I can't find it elsewhere.

103

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

It is on ST.
You can see it here in most browsers.
Center it on your screen, hit "Control+" repeatedly until it is large enough for you to read, Bill.

Control minus to reduce the size.
======================
I don't mind a loss of 2 cents today but I don't think it is representative of the real day's trading. It was a manipulation down as we got to the end of the day.

Are they trying to trigger trader profit-taking or just ensuring the chart doesn't get too overbought????

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

greenguy wrote:

Alan, that chart is illegible for me and I can't find it elsewhere.

You can find the original chart here:

https://docs.google.com/spreadsheets/d/ … sp=sharing

105

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Thank you!

106 (edited by Jim Burns 2021-02-05 18:14:54)

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Does this Israeli drug for Covid have any impact on what OMER has in the pipeline such as narsolimab?


https://www.yahoo.com/news/israeli-covi … 09164.html

107

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

The photo came from a BBC news story aired at the beginning of this week, or perhaps last week.  I was surprised that I didn't remember anything about this breakthrough from that newscast, and took a closer look, and the picture is of people celebrating getting the vaccine.  It has nothing to do with this company or drug that is beneficial to covid patients.

We definitely need more details on the condition of the people treated to draw any real conclusions, but it this is cheap and could be administered early and works then it could be widely used.  Narso seems to be positioned for very ill covid patients, probably worse than those in Israel, but eventually given the scope of covid there unfortunately seems to be enough patients to go around.

108 (edited by Alan Robert Ross 2021-02-05 20:28:17)

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

This is a Phase 1 trial, which usually has people without the disease get treated to find out whether it harms normal people.

The population tested is not the same as narso and was much less severe, so survival was NORMAL. Narso was tested on people on ventilators where survival is 25%.

I don't think Greg wants narso to be used to treat anyone but the most severe, and at a relatively high price. I could be wrong or once approved, it will be used for the less severe cases ho can afford it.

Also, only 30 to 40% of severe covid cases die from LUNG issues. The rest of them die from problems in other organs.

IT IS NOT ABOUT LUNGS.
IT IS ABOUT EIS.

Endothelial Injury Syndrome.
At least according to Omeros and Greg.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

109

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

That Israeli drug was given to 30 hospital patients with moderate to severe Covid.  So, if the phase 2 trial, presumably with a larger enrollment, shows the drug is still effective with severe cases, it might be a cheap option that cuts into narso revenue.

110 (edited by dorcse 2021-02-05 22:38:16)

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

"The preparation is inhaled once a day for a few minutes, for five days,” Arber said. “The preparation is directed straight to the heart of the storm — the lungs — so unlike other formulas… which selectively restrain a certain cytokine, or operate widely but cause many serious side effects, EXO-CD24 is administered locally, works broadly and without side effects.”

Can't know if any of those patients were intubated.   How could they be breathing in the miracle drug?  Do they add it to the oxygen feed?  I'd really need to know a lot more and details are scarce.

111 (edited by Alan Robert Ross 2021-02-05 21:57:26)

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Jim, did you miss my post?
There are lots of other cheap and not so cheap treatments now, but they are not very effective.

As I mentioned, only about a third of patients have the lungs as their main problem and the Israeli drug (and their drugs are touted routinely, for everything, with minimal proof) was NOT used on people with severe cases. If they reduce the severe cases a lot, all the more power to them.

Note that the survival rate for the level of patients they treated was HIGH for those with standard care

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

112

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I did not miss your post.  My point was that some of 30 Covid patients did have severe symptoms in the Israeli phase 1 trial.  But I realize that was a very small N and there needs to be much larger phase 2/3 trials before we know anything substantive about this drug, it could be a big flop.

113

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I searched clinicaltrial.gov for the trial and it is not there.

The news report illustrated the happiness of the researchers by publishing a photo that was NOT of the researchers involved, or of people celebrating these results:
"Medical teams celebrate before receiving coronavirus vaccines as Israel kicks off its coronavirus vaccination drive, at Tel Aviv Sourasky Medical Center "

Yahoo wrote:

The treatment was given to 30 patients with coronavirus, whose conditions ranged from moderate to severe.

This is somewhat meaningless.
Was there 1 or 20 moderately ill patients?
What was their criteria for "severe"?
Where is the comparator?
Surely they have lots of people with records they could use. Were all these patients hospitalized?

What does this mean?

A protein known as CD24 is delivered to the lungs by exosomes in the drug, which helps to rebalance the immune system and prevent it from overreacting to the virus.

That is meaningless as a MOA.

In Bergamo Naroplimab treated patients who were made unconscious, given muscle relaxants and intubated to ventilate them. This is a short step to the morgue for 75% of the patients who have progressed this far. This is the end stage of severe.

25% survive without narso.

There does not have to be much larger trials if/when they test the drug (any drug) on a homogeneous population, with definitive and obvious endpoints.

In this trial, you are not given the patient characteristics and you have ZERO idea that they were discharged from the hospital faster than they would have been if they were not treated with the new drug. You are also not told how the drug works, and you are told it is Phase 1, which normally use normal people to establish safety and side effects across doses.

That they did not report the details that would allow evaluation, could have been the failing of Yahoo's source "The Telegraph".

For some reason, lots of similar touting coverage originates in Israel....

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

114

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I presume that Israel's drug regulations about trials and what you say about them are more relaxed and/or different than the USA. And that local media, especially in something other than Hebrew, tend to promote Israel's business and science.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

115

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

There are several other useless reports of 'successful treatments' devoid of proof or where earlier stage patients were treated.

I don't bother to post them because the information is without scientific rigor or not strikingly successful.

Remember that in Northern Italy during their first emergency hospital overload they were trying just about anything.

Meanwhile drug companies, even including Provectus, have been trying to show how their existing drugs would work against CV19, to boost their stock. If they did not get a following from the deluded but powerful, they made no headway because the data proved it was BS wishful thinking from the start.

I am happy to read about these reports and your comments that show that TIPSters are asking skeptical questions.

The Science communication landscape has changed since Covid. Before there were limited venues for scientific (not mass media) reports that appeared on the web within days of submission. Now there are many more and journal articles also are available both before and after they are reviewed by peer scientists.

Chances are, if you see some report about covid that is in mass media, with NO link to the scientific writeup, it is puffery: an attempt to attract attention, and without the kind of data that is scientifically useful.

Even in a published paper, you cannot believe their conclusions unless you have read the method section and then the results. I can't stress this enough.

Who they tested, how they defined and tested the endpoints tested, etc. are of crucial importance.

This is probably one of the reasons that Greg has prioritized the first narso indication(s) to have an obvious and striking endpoint.

Is the patient dead or alive doesn't leave much room for critiques from the likes of idiots like AF.

You don't need 1000, or even 100 patients in this kind of trial if your treatment leads to consistent results. It is cheaper and less time consuming to do these trial... another reason why Greg prefers this kind of drug development program.

Narso for HSCT-TMA only needed 28 patients to satisfy the FDA, for a rare orphan indication.

How many patients do you think the FDA is going to need if the narso-CV19 data are similar?

For HSCT-TMA survival was ~10% w/SOC and FDA said it would approve if 15% or above...with n=28

Ventilated CV19 patients survival with SOC is 25%. You tell me what % survival the FDA will require and the N.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

116

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Happy Talk and Hopium have allowed people to be in denial (some enough to catch it and die) since the beginning, but it has been obvious it would evolve, not be disappear. Greg may have to switch to treating sequelae in developed markets.

Because CV19 and its offspring are not going to disappear for a whole variety of reasons. I have been talking about mutations since it started, in another form than it existed in, back then, in China.

http://www.trustintelligence.com/viewto … 2841#p2841

This will permanently change our lives, business, and even culture.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Alan Robert Ross wrote:

This will permanently change our lives, business, and even culture.

Permanent is a very long time.  So in 200 years the changes brought on by Covid 19 will still be around?  I'm always very hesistant to say anything is permanent given how even over the past 500 years science and technology have radically changed human society.

118

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

For ALL TIME, perhaps not.

Permanent (to me) is our lifetimes...

Most of us don't contemplate what the article says is the normal biological evolution coupled with human noncompliance, drug development timeline, etc.

You think there will NOT be another virus like this, but different? In addition to CV19 mutations?

And changing the culture tends to last a long time.
It has already changed... and with half of America unvaccinated it still will have an effect.

This is doubly true because the vaccine you may get this or next month may have only a 50% or 20% chance of protecting you from the next variant, which your Virus-Deniers and Anti-Vaxxers will carry and transmit to people who have been vaccinate.

Do we believe that Covid19 itself will not continue to mutate and escape the effects of future vaccines until something is developed with a time lag of at least 9 months?

Ironic narso will save the lives of Antii-Vaxxers and Virus Deniers and the ones who curse the Chinese Virus and purposely don't distance or wear masks as a political statement or because they don't care what happens to others.

Nobody wants to believe this.
We all want to go back to the way it was.
That will happen only if we become deniers and pay the price ourselves.

IOW, people can be dangerous to our health.
Precautions will start to be built into our world.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

119

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I think between vaccines AND an effective treatment like Narso and others that Covid 19 will be around for a while but will be less of an impact.  I don't think severe lockdowns are sustainable for more than a few months.  I don't think the death rate or even long term injury rate is high enough to convince people to sustain long term severe lock downs.   That has been proven so we need to get vaccines out to as many people as possible and get Narso and other treatments approved.

On a long enough time line everyone will die....

120

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Enough people WILL NOT take the vaccine.
The numbers in other countries are not all that dissimilar to the US. France is at ~50%.

With CV, you need to do total lockdown for maybe 3 weeks. Who did that besides the Chinese?

To do it, you must change the culture.

In Feb. 2020 we could have said... if this that or the other thing is done, we'll beat the pandemic.

Too little proactive action was taken. Too many people will not cooperate... and if they do, that in itself will be a major change in culture.

Saying we will have more dangerous viruses says nothing about lockdowns as a cure or a means to stop them.

Economically and investment wise, there will be a predictable migration away from mass in-person events to virtual events. Online gambling, perhaps in a Zoom environment so you do it with your friends without being physically close to them and 1000s of strangers milling around in a casino.

The ways to make money will migrate towards safety as those who take less precautions become the ones most likely to get sick, potentially disabled by sequelae, and to die.

And as soon as one of the CV19 variants mutate to act like the 1918 FLU VIRUS, killing people between 16 and 30... we will have horrible mayhem and the changes to society will shift even faster.

There is NO good reason that I see, that the old are the prime hosts for a virus. Sooner or later there will be one that attacks the young (and there are NO vaccines approved for children yet).

In my family, a 55 year old niece working in a Quebec nursing home got CV19 and she gave it to her 16 or 17 year old son who was the last child left at home. He got it much worse than she did.

If the young start dying it will speed up the changes because we protect the young and (still figuratively, if not actually in polite society) send the oldsters out on an ice-flow to die when they can't take care of themselves.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

121

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

While people taking the vaccine slowly increases, people intending to take the vaccine, instead of being an anti-vax person (who obviously does not understand how probabilities work) have been increasing.

Offsetting this are the new and increasing variants that will lead to people who HAVE been vaccinated, still potentially getting infected with a new virus strain... sooner or later.

A cure will still be needed.

Which brings up the supposedly started, supposedly continuing Phase 2 narso trial for I-SPY in CV19. Monday will start the 4th week in February, potentially the 4th week of dosing in the trial, if the trial started promptly on 2/1/21 (an interesting combinations of numbers for the date).   

We have no hard evidence of the start, nor when it was. Even I am finding myself wondering and I think I am moderately patient. I am going to reach out to some contacts to see if they heard anything.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

122

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I have investigated and found a lack of ongoing bullish posts by the source of the ISPY contact... and another contact asked about ISPY and got no response.

This is consistent with the original source being told current status but cautioned about publicly spilling confidential info.

If I have to guess, I think the guy knows the testing has started by is abiding by the PR protocol that requires the sponsor to make or approve announcements.

That is my best guess.
The source is an academic scientist and would be foolish to ruin his career to post something on social media.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

123

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Yes, that person should protect themselves for sure.  That said, my main question is that it has started at all, and less about how it is progressing (which I assume will take care of itself once started).

124

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I found this website which has information about Narso and Covid 19

*******************

Project AIM
AIM (Artificial Intelligence in Medicine) is a project aiming to apply machine learning to the field of medicine. AIM aspires to collect and provide up-to-date research information related to a serious medical issue. The use of artificial intelligence makes processing an enormous amount of scientific data possible.

To ensure reliability, scientific experts verify the output provided by the AIM tool. This way the general public gains access to the most complex information related to the specific medical issue. This includes drugs in various stages of development or natural substances that could help alleviate the symptoms of the medical issue in question. Here, we applied AIM to the research of therapeutics for COVID-19, which has yielded more than 100 substances.

For whom
This project is aimed at providing up-to-date information on the research of COVID-19 treatment options for researchers, medical providers, as well as the general public.

https://covid19-help.org/substance/narsoplimab

125

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I did not see anything useful, Larry.
It is only as good as its programming. They have zero Mode of Action, not Translational data and not even mention of the post-hoc controls.

They know of only a limited amount of information, so that companies like OMER, who keep things as secret as possible, obviously show up as black holes.

Just because it says it is intelligent doesn't tell us whether it can predict a winner any better than a skilled human, right?

But perhaps I missed something.....

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

126

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

No and if Omeros posted more public information about Narso especially on their website it might help to make more people aware of it.

127

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

It seems obvious that they either are not free to post anything about ISPY without permission or they have reasons why it is better (in their view) to not make anything new, public.

But we do not need a computer program (with unknown programming, and incomplete data) to tell us this. Actually I am surprised that an AI program does not analyze all published work on Mode of Action as part of the analysis. That something is a monoclonal antibody is irrelevant unless you know what the antibody inhibits and what system(s) that inhibited mechanism are affected so you can then compare them to the various aspects of the systems that cause the problem(s) we are looking to cure.

If the AI program doesn't do that, it is probably in an early stage of development in which it is less useful.

I want to see this show get on the road to Omeros being ridiculously OVERvalued.  I don't like waiting, but at least we are holding price when tech and biotech indexes are declining.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

128

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

There is a link, at the top of this page
https://quantumleaphealth.webflow.io/po … -spy-covid

that lets you click to the News and Announcements for the ISPY trial.

If you check, you will see that there is NOT 1 item that was issued in 2021.

Nothing at all.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

129

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Look at the bottom of this presentation slide for OMER's disclosure of the ISPY trial participation.
https://charts.stocktwits.com/production/original_292482541.png

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

130

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Speaking for myself only - if I have been too critical in the past, right now I don't know what else we could ask for.  DOING IT THE RIGHT WAY TAKES TIME.  Seems like we are getting there.

"In discussions with international regulatory authorities" - sounds like potential for a world-wide market, to me.

"Advancing discussions with BARDA....." - what else can we ask for?

131

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Brozack was a Democratic candidate for office in 2004 so he may still have connections... and Biden would have himself a solid advance if they can find a drug treatment that keeps Americans from dying of the virus, shown to work by data on saving the most severe cases.

We just have to wait and see what Greg comes up with. Long ago, he said that he was continuing to try to get the Trump Administration to support Narso but that, if they didn't, he try the next Administration.

A day or two ago, I posed about Dr. Hood interviewing Dr. Anthony Fauci. Dr. Hood is a director of Omeros and he just bought some more shares by exercising options.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

132

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

There is no question but that Trump is a mean SOB.  I believe he truly didn't give a you-know-what about the virus, and whether or not people lived or died.  When/if the Biden Administration introduces Narsoplimab to the public, I hope someone connects the absence of same with the Trump Administration, such that perhaps a few people here and there can put 2+2 together and see how harmful that Administration was to the very citizens it was sworn to protect.

133

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Treating sequelae will be a huge task, with many patients over a long time period.

https://charts.stocktwits.com/production/original_292728494.jpg

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

134

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I think there is a good market for treatment for Covid 19 just like their is good money for a treatment for the flu.  Tamiflu does over 1 billion in sales an the flu is less deadly than Covd 19 and Tamiflu has been around for over a decade.

"According to the report, the global Tamiflu (Oseltamivir Phosphate) market was valued at approximately US$ 1.1 Bn in 2018."

135

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

And tamiflu does not work if you take it after being infected for ~2 days.

Tamiflu is very inexpensive compared to the likely price for narso... not that we can know for sure yet. As a monoclonal antibody it will cost more to make narso than they charge for Tamiflu.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

136

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

And tamiflu does not work if you take it after being infected for ~2 days.

Tamiflu is very inexpensive compared to the likely price for narso... not that we can know for sure yet. As a monoclonal antibody it will cost more to make narso than they charge for Tamiflu.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

137

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Posted on STwits
============

$OMER
 

Among other interesting points discussed, this one grabbed my attention: 

"The deltoid skin biopsy has been utilized for a number of years at Weill Cornell Medicine to detect evidence of systemic complement activation, although in a different clinical setting, namely to rule in or out atypical hemolytic uremic syndrome. We performed the deltoid biopsy on patients with severe and critical COVID-19 to document systemic complement activation; by documenting systemic complement activation, an additional therapeutic intervention with complement inhibition therapy was possible"

I speculate that the therapy, not disclosed in the article, that they refer to could be narso based on:

1. the whole article points at the role of lectin pathway in CV19 pathophysiology
2. Weill Cornell Medicine is home to Dr Laurence
3. no reason not to disclose other therapies already in publicly known trials

https://www.the-dermatologist.com/artic … lts?page=0

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

138

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

OpenClinica, Quantum Leap Healthcare Offered Backing to Power Growth of I-SPY Covid Trial
22nd February 2021

Researchers worldwide are working to find reliable and effective Covid-19 treatments. OpenClinica, a leading clinical research software company, is conducting an extensive adaptive platform trial alongside Quantum Leap Healthcare Collaborative for patients hardest hit by Covid-19. In December 2020, the trial’s significant life-saving potential drove a major contract to Quantum Leap Healthcare to expand and accelerate their efforts. The investment is being used to scale the phase 2 clinical trial, boost patient recruitment, and accelerate data collection by extending the trial into non-academic hospitals and non-research centres.

“We initially built a relationship with Quantum Leap Healthcare when our clinical trial software supported their signature breast cancer adaptive trial,” explains OpenClinica CEO Cal Collins. “When the Covid-19 crisis hit, their leadership team identified that a similar adaptive platform trial design could quickly and efficiently find effective Covid-19 treatments.”

Although adaptive platform trials are not a new paradigm, their advantages are on full display in this particular trial application due to the Covid-19 public health crisis. This study design approach allows multiple therapies to be trialled at once, with new treatments continually added as they become available. Once sufficient data is gathered on treatment or it is deemed ineffective, it is retired from the trial. Amending the trial to incorporate new treatments—rather than setting up a parallel trial—radically decreases time to get new treatments incorporated by streamlining IRB approvals, study protocols, staff training, and site approvals. “It is a really efficient way to trial multiple indications and medications in one study,” says Collins.

The initial trial began in the summer of 2020. All trial participants are seriously ill with Covid-19 respiratory symptoms, with most in ICU on supplemental oxygen, intubated, or ventilated. The funding provided through the partnership will allow the trial to continue and collect data on potentially up to 1,500 patients throughout the US.

An innovative aspect of the trial is its targeted integration and interoperability with electronic medical records. Integrated data will soon be possible at the patient’s bedside for this trial via mobile devices that link EMRs and the research system. Covid-19 is proving the impetus and urgency to integrate research and care processes using technology in order to find effective treatments at a faster pace. “It’s crucial that we move past old ways of doing research, and harness technology to move faster and reach more patients,” says Collins.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

139

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Another ISPY-related but again NOT from the sponsor: Quantum Leap.
===============
MemorialCare Participating in I-SPY COVID Trial to Evaluate Treatments for Severely-Ill COVID-19 Patients
Friday, February 05, 2021

MemorialCare Long Beach Medical Center continues its fight against COVID-19 as a participant in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning). The focus of the trial is to improve outcomes for severely-ill COVID-19 patients.

The I-SPY COVID Trial is an adaptive platform trial that incorporates a single-study structure to evaluate multiple treatments independently within the same trial. This method allows for the rapid assessment of potentially impactful therapies. All patients admitted to the hospital with COVID-19 requiring high flow oxygen or mechanical ventilation are screened for potential participation in this trial. If a patient meets inclusion criteria and provides consent, they are randomized into one of several study arms, either offering established standard of care or one of several unique treatment options in addition to the established standard of care. The patient’s medical outcome will be closely evaluated, offering valuable data on the safety and efficacy of the various treatment options included in the study.

MemorialCare’s research team is led by board-certified pulmonologist, internist, and critical care specialist, and Principal Investigator Fady Youssef, M.D.

“This unique study design allows us to test several agents at once. The data is then quickly analyzed and a determination is made as to whether to advance the agent into a bigger trial or consider an Emergency Use Authorization Request if the results prove to be truly astounding,” explains Dr. Youssef. “The I-SPY study provides us a window into how future trials may be conducted, and we are hopeful that it will help us identify efficacious therapies that can potentially alter the course of this pandemic.”

Sponsored by Quantum Leap Healthcare Collaborative, the study is a collaboration among pharmaceutical industry members of the recently formed COVID Research & Development Alliance and others; a partnership of medical clinicians and researchers; and the Food and Drug Administration. For more information about the study, please visit Quantum Leap Healthcare Collaborative: I-SPY COVID (quantumleaphealth.org)

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

140

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

file:///C:/Users/Ross/Downloads/10.1515_med-2021-0239.pdf
Namarta Kalia, Jatinder Singh and Manpreet Kaur
The ambiguous role of mannose-binding lectin (MBL) in human immunity
De Gruyter | 2021
DOI: https://doi.org/10.1515/med-2021-0239

Abstract
Mannose-binding lectin (MBL) and lectin complement pathway have become targets of increasing clinical interest. Many aspects of MBL have been recently explored, including the structural properties that allow it to distinguish self from non-self/altered-self structures. Experimental evidences have declared the additional 5′- and 3′-variants that in amalgamation with well-known secretor polymorphisms change MBL function and concentration. Moreover, the current review highlights the differential behavior of MBL on exposure with extra/intracellular pathogens and in autoimmune diseases, stressing the fact that “high MBL levels can increase diseases susceptibility,” a paradox that needs justification. Attributable to these discrepancies, no absolute level of MBL deficiency could be defined so far and thus must be interpreted for specific diseases through case–control population-specific designs. Overall, it is evident that further research is needed about MBL and the lectin pathway of complement. Particularly, the transformative role of MBL over evolution is of interest and its role with regard to pathogenesis of different diseases and potential therapeutic targets within the respective pathways should be further explored. Apart from this, it is necessary to adopt an extensive locus-wide methodology to apprehend the clinical significance of MBL2 polymorphisms in a variety of infectious diseases by the future studies.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

141

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

In the 10K there is a table with the pipeline. It contains more detailed description of what are the NEXT MILESTONES for the first time I can recall.

For narso in CV19, it shows Omeros is in Phase 3 and that the next milestone for "Severe Covid requiring mechanical ventilation is

Complete clinical trial and/or obtain regulatory authorization

This tells us that they are not banking on sequelae to get approval.

Sequelae could be treated separately off label or there could be a second approval, later. A trial for Sequelae, of course, would take at least 6 months longer than one for survival of severely ill patients.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

With symptoms from rashes to strokes, is COVID a blood vessel disease?
Will Stone | Kaiser Health News | March 3, 2021
https://content.geneticliteracyproject.org/wp-content/uploads/elementor/thumbs/j-sbpdmun-fulbzl-qyuvg-scaled-oz97832g1mut3maibn0a0hgekq6y4ta1yyl74sblci.jpeg
Credit: MR.Cole_Photographer/Getty Images
This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.
Some of the earliest insights into how COVID-19 can act like a vascular disease came from studying the aftermath of the most serious infections. Those reveal that the virus warps a critical piece of our vascular infrastructure: the single layer of cells lining the inside of every blood vessel, known as the endothelial cells or simply the endothelium.

Dr. William Li, a vascular biologist, compares this lining to a freshly resurfaced ice rink before a hockey game on which the players and pucks glide smoothly along.

“When the virus damages the inside of the blood vessel and shreds the lining, that’s like the ice after a hockey game,” said Li.

In a study published this summer, Li and an international team of researchers compared the lung tissues of people who died of COVID-19 with those of people who died of influenza. They found stark differences: The lung tissues of the COVID victims had nine times as many tiny blood clots (“microthrombi”) as those of the influenza victims, and the coronavirus-infected lungs also exhibited “severe endothelial injury.”

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Here is something more technical, but it is from October 2020, when ISPY was on using other drugs to treat Covid patients.
==================
I-SPY
The I-SPY COVID-19 study is a multi-center, Phase 2, open-label platform trial designed to rapidly test
novel therapies for critically ill patients with severe or immediately life threatening COVID-19, with the
goal of reducing mortality and morbidity, as well as the impact on healthcare utilization.
If interested in the therapeutic portion of the trial, participants will be randomized to control or
treatment therapy, with both groups receiving standard of care backbone interventions including
supportive care for Acute Respiratory Distress Syndrome (ARDS), including daily EUA remdesivir (x5 or
x10 days) and if needed, lung protective ventilation. Steroid therapy is allowed/encouraged. Participants
will be asked to sign a consent form for the backbone treatment and a SINGLE specific investigational
agent arm to which they are assigned. Up to four investigational medications may be active at any given
time.
The current four agents to be tested include:
 Apremilast: (Otezla®)inhibits PDE4 intracellularly and has anti-inflammatory properties
 Cenicriviroc: a dual-CCR2/CCR5 antagonist, has potent anti-inflammatory and anti-fibrotic
activity
 Icatibant: (Firazyr) specific antagonist of bradykinin B2 receptors
 Razuprotafib: designed to attach to and block vascular endothelial protein tyrosine
phosphatase (VE-PTP), a key negative regulator of Tie2. Reduced Tie2 activity is known to
cause vascular instability in various diseases.
Agents can seamlessly be added or dropped from the trial without interruption to the trial, based on
safety and effectiveness. Agents will be approved by IRBs and be in the queue for addition once other
agents leave. All investigational medications and EUA remdesivir will be provided by the study sponsor.
Additionally, an observational cohort of patients with similar clinical stages of COVID-19 will be followed
via medical records. The goal of this registry cohort is to better understand how patients enrolled in the
clinical trial compare to other local patients. In addition, data will be shared with the local clinical team.
Participants will continue on the study until protocol completion or removal. Regimens will be dropped
if they are not sufficiently effective. The primary endpoint is time to achieve a durable COVID-19 status
level 4 or lower. For this trial, a durable level is defined as at least 48 hours at COVID level 4 or less
(nasal prongs oxygen) without returning to high flow oxygen or intubation. 1000 participants will be
enrolled across all sites, with up to 50 participants enrolled at the University of Colorado Hospital.
Inclusion Criteria. Subjects must meet all of the following inclusion criteria to be eligible for
participation in this study:
1. Male or Female, at least 18 years old
2. Admitted and placed on high flow oxygen (greater than 6L by nasal cannula or mask delivery
system) or intubated for the treatment of (established or presumed) COVID-19.
3. Informed consent provided by the patient or health care proxy.
4. Confirmation of SARS-CoV-2 infection by PCR prior to randomization.
11
Exclusion Criteria
1. Pregnant or breastfeeding women
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition
to Study Agent based on review of the medical record and patient history.
3. Comfort measures only.
4. Acute or chronic liver disease with a Child-Pugh score greater than 11.
5. Resident for more than six months at a skilled nursing facility.
6. Estimated mortality greater than 50% over the next six months from underlying chronic
conditions.
7. Time since requirement for high flow oxygen or ventilation no greater than 72 hours.
8. Anticipated transfer to another hospital which is not a study site within 72 hours.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

It would be good to clear up what exactly "critically ill patients with severe or immediately life threatening COVID-19" means.  If patients have supplemental oxygen but are not on a ventilator for example do they have ARDS?  The devil is in the details here I think.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I think it clear that ISPY patients are not as severely ill (yet) as OMER CUP patients and I believe Greg said as much, explicitly.

Narso does not just treat ARDS, which is only focused on the respiratory aspect of the endothelial damage. Lots of the people who die from Covid have strokes and other thrombotic damage.

Multi-organ damage is characteristic of HSCT-TMA too. And that's why narso is being used to treat kidney damage in IgAN.

The risk in ISPY for Omeros is that narso is less obviously a breakthrough because the effect of treatment is less obvious than when the patients are treated at death's door.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Alan Robert Ross wrote:

The risk in ISPY for Omeros is that narso is less obviously a breakthrough because the effect of treatment is less obvious than when the patients are treated at death's door.

That is a very important point and I hope Greg is aware of it.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

He mentioned it on the CCall, Larry.
So no worried.
Chances are if we know something someone in Omeros also knew it before us, in most cases.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

http://www.trustintelligence.com/viewto … 3798#p3798

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Appelis is a complement system drug company valued much higher than Omeros.
*****************
Apellis Pharma halts Phase 1/2 trial for APL-9 in severe COVID-19
Mar. 04, 2021 4:37 PM ETApellis Pharmaceuticals, Inc. (APLS)By: Dulan Lokuwithana, SA News Editor

Apellis Pharmaceuticals (NASDAQ:APLS) announced that it would no longer pursue the clinical development of C3 inhibitor APL-9 for the treatment of severe COVID-19 after finding no meaningful reduction in the overall mortality rate.

The decision has followed an interim review by an independent data monitoring committee (DMC) which has analyzed the mortality data from the Phase 1/2 study where APL-9 was evaluated in combination with standard of care therapy versus standard of care alone.

The DMC has however found no safety signals. The company plans to disclose the full results in a scientific forum after the completion of full data analysis.

Having the same mechanism of action as Apellis’ lead compound, pegcetacoplan (APL-2), APL-9 was undergoing Phase 1/2 trial since May 2020.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I guess their trial was large enough to have a DMC.  One would think if OMER had such a trial, the DMC would stop it and recommend immediate use for all trial participants on ethical grounds.