Topic: Omeros & ISPY
This interested me because they had trouble getting their drug tested on people with severe cases, in the US.
The article implies that it could have been that the FDA did not allow it.
https://endpts.com/altimmune-abandons-s … rial-flop/
June 29, 2021 04:56 PM EDT R&DCoronavirus
Altimmune abandons ship on intranasal Covid-19 vaccine, refocusing on liver, obesity programs after trial flop
Among the also-rans in the Covid-19 vaccine race, small biotech Altimmune hoped to ride a novel intranasal formulation for its own candidate to market but ran into an FDA clinical hold along the way. Now, after the vaccine turned out a dud in an early-stage test, Altimmune is bailing out and refocusing around its other programs.
Altimmune’s single-dose vaccine, dubbed AdCOVID, didn’t spur an adequate immune response in a Phase I test in 80 healthy volunteers, the biotech said Tuesday. Meanwhile, the vaccine was well tolerated, but the lack of results was good enough for Altimmune to walk away.
Altimmune CEO Vipin Garg called the results “disappointing” in a statement, particularly after the biotech thought it saw promise in preclinical studies. Shares of the biotech $ALT were trading down nearly 33% after the bell at around $10.
Also on Tuesday, Altimmune revealed it would hit the pause button on its lesser-known immunomodulatory candidate for Covid-19, dubbed T-COVID, after running into difficulty enrolling high-risk Covid-19 patients above the age of 65. The company attributed that challenge to the successful rollout of Covid-19 vaccines in the US and said they would end development in the high-risk cohort while feeling out a potential path in low-risk patients.
AdCOVID’s road to the clinic was delayed back in December after the FDA put a halt on the company’s IND application after citing issues with the vaccine’s trial protocol and CMC issues. After agreeing to the FDA’s demands, Altimmune opened enrollment in Phase I in February, giving patients either one or two doses of the vaccine at three separate dose levels.
The biotech said its vaccine did spur some antibody response but not enough to keep pace with the vaccines already approved for emergency use.
Founder, Trust Intelligence
The foregoing is not investment advice.