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Monday, May 13, 2024 9:03:01 AM
My take is that they missed the primary end point and are on the edge of the long-Covid data so are extending the trial to see if they can at least hit the reduction in the incidence of long Covid.
https://www.shionogi.com/global/en/news/2024/05/E_20240513_1.html
The missed the primary endpoint, and also missed the long covid endpoint at 12 weeks (still awaiting the 24 week data)
They did show a stat sig difference on the narrower 6 symptom endpoint
they did hit virologic endpoints which as you know ENTA missed, although this trial had 30% high risk patients so the viral load curve in placebos could be very different than ENTA's phase 2 which was almost entirely low risk. Will be interesting to see the curves
bullish for paxlovid
not sure if this raises the probability for 235 now - these phase 3s have been failing left and right, but perhaps NIH will feel like they just picked the wrong horse?
This really goes to show you the differences in the pt population in the prior phase 2/3 in asia which was in a younger healthier population than this trial so if anything you would think this trial would have a better chance of hitting
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