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DewDiligence

05/13/24 3:20 PM

#2960 RE: dewophile #2959

More on Shionogi’s COVID trial:

https://www.fiercepharma.com/pharma/shionogis-homegrown-antiviral-comes-short-global-covid-trial

Notably, the article cites Shionogi’s CEO saying that Xocova could generate $2B of annual sales if approved in the US. It’s unclear how much of this hypothetical sales figure comes from COVID patients who would otherwise have taken Paxlovid vs COVID patients who would otherwise have taken no drug.
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vinmantoo

05/14/24 12:09 PM

#2962 RE: dewophile #2959

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?



dewophile, thanks for the heads up. I would have commented earlier was off in Las Vegas for a few days of relation and fun in the sun. The last few years I have been going in early May or late September to avoid the 115° days. I could deal with 115° when I was younger but not anymore. The temp on this trip was in the 80s and low 90s so just right for lounging in the pool.

As far as Shionoig's Ensitlevir trial, the data was even worse that you indicated, at least in comparison to EDP-235. For the link you provided;

A pre-defined supportive analysis of resolution of six symptoms for one day using a statistical method similar to that used in the SCORPIO-SR Study (Phase 3 part of the Phase 2/3 study of Ensitrelvir conducted in Asia) yielded a significant difference (p<0.05) in the time to resolution of symptoms.



Even their 6 symptom sub-group, they only saw a 1 day improvement whereas EDP-235 showed a 2 day improvement with the higher dosage of EDP-235. Obviously EDP-235 was a small phase 2 and didn't include any high risk patients, but it does indicate EDP-235 could be superior. Now if we can only get a mid-sized or big pharma interested in EDP-235. I don't think the viral curve data means much, at least without any analysis of whether their patient population contained a larger number of Covid infection naive people. That might be the case for high risk patents as they could have taken a lot of steps to avoid prior infections.