Phase 2 results on Atea/Roche #covid19 antiviral AT-527 just out. Didn't meet goal in reducing virus in mild to moderate Covid in overall study population, which co says was 2/3 patients at low risk w mild symptoms. But says there was a reduction for high-risk patients (1/2)
Atea says it and Roche are assessing modifications to their phase 3 #covid19 antiviral trial, and now expect results from it in the second half of 2022 (2/2)
Shares of Atea ($AVIR) are down 65% pre-market after a trading halt
Atea notes its #covid19 antiviral study participants (2/3 of whom had no underlying health conditions) were on average 37 years old, & included people who were vaccinated.
(Merck study of molnupiravir focused on patients at high risk, and nobody was vaccinated in trial.)
Evercore ISI analyst Umer Raffat says Atea/Roche antiviral didn't "fail" in phase 2 - says it's just the trial design that disappointed.
Umer says viral load benefit seen in high-risk subgroup "is comparable to MRK"
If so, disappointing this won't be available for at least a yr
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I just spoke with Dr Katherine Poehling from Wake Forest, one of the CDC advisory cmte members whose vote was ostensibly overruled by @CDCDirector Dr Rochelle Walensky on Pfizer #covid19 booster.
I say ostensibly, because Dr Poehling says she feels like Dr Walensky listened. (1)
ACIP member Dr Poehling:
“We’re an advisory committee, and I felt like our perspectives were clearly heard. And so I felt like the process actually worked well.” (2)
Dr Poehling says she voted no because she was concerned people in that last category (at occupational/setting risk) would feel they didn’t have a choice BUT to get a booster.
But Dr Walensky's recommendation added the word "may" for that category. (3)
FDA notes at CDC advisory committee meeting that it has a Moderna submission for #covid19 vaccine booster, and “we are working diligently to get that completed.”
FDA says it’s working with partners including NIH to provide a solution about boosters for all - “I don’t know if I can provide a specific timeframe,” Dr Doran Fink says.
Dr Peter Marks joins: “We understand at FDA the relative urgency here of trying to have a solution for anyone who’s been vaccinated with any of the authorized or approved vaccines. Unfortunately we’re not in a place right now where I can give you an exact timeline… (cont)
FDA booster meeting Q&A begins w Dr Marion Gruber turning it over to Dr Phil Krause, who notes much of the data being discussed today is "not peer-reviewed and has not been reviewed by FDA."
Asks Pfizer whether Kaiser model accurately reflects true vaccine effectiveness
Dr Krause highly critical of Kaiser study supporting Pfizer conclusions
And Pfizer is having crazy audio issues responding to Dr Krause
Agenda posted for FDA advisory committee meeting Friday on #covid19 boosters. Departing regulator Dr Marion Gruber kicks off the morning with an introduction of the topic (after this week co-authoring letter saying boosters not needed): fda.gov/media/152159/d…
Also interesting, on FDA’s agenda for Friday booster shot advisory mtg: presenters from UK & Israel on real-world evidence
In its briefing docs for Friday’s FDA booster mtg, Pfizer lays out the case for boosting at 6-8 months, citing data from Israel & US. Notes the erosion is likely due more to waning effectiveness than Delta escape: fda.gov/media/152161/d…
Moderna says its vaccine shows durable 93% efficacy through 6 months, says it expects to complete FDA submission for full approval this month: investors.modernatx.com/news-releases/…