Replies to post #2965 on Enanta Pharmaceuticals Inc (ENTA)

[dewophile]

Hi Mouton - yes I was aware the EPIC-SR results were finally published (failure of the trial as you know was publicized nearly 2 years prior). I alluded to this in my post listing paxlovid as one of the drugs that failed to show a difference in sustained resolution of the 15 symptom endpoints. Japanese regulators allowed Shionogi to focus on fewer endpoints that were more common especially with current variants for approval.
As I said to Vin it could be when data from the SORPIO-HR trial (ensitrelvir) is made public (hopefully it won't be after a 2 year lag like the PFE trial) a cross trial comparison can be made to gauge EDP-235 relative to ensitrelvir on symptom endpoint.

[vinmantoo]

Paxlovid - dewqophile and vinmantoo, I strongly suspect you both know this, but in the Paxlovid EPIC-SR trial reported in NEJM in April, Paxlovid flopped completely on syptom relief. https://www.nejm.org/doi/full/10.1056/NEJMoa2309003

Mouton, Thanks for bringing that up. Yes I remember that Paxlovid failure of symptom relief but it is worth repeating now. It failure in symptom relief in all groups, including high risk and standard risk patients regardless of vaccine status. Together with Shinogi's Ensitrelvir failure it would seem to provide an opening for EDP-235. Paxlovid was approved early in the pandemic based on it's ability to reduce hospitalization and death. The general population is now highly immune so the thankfully, death and hospitalization are much lower. That makes symptom relief the major endpoint the FDA should be concerned with. Whether they will insist on all 15 symptoms of a key subset is the big question as dewophile has pointed out.

The huge Panoramic trial in the UK has finally stopped enrolling and will follow patients till September. https://www.panoramictrial.org/ Presumably results will be reported not too long after that, but who knows, they do seem to be taking their time. That's a randomized trial of Paxlovid v. standard of care in a vaccinated population. If Paxlovid doesn't show a benefit (either in symptom relief or reducing hospitalization/death), will that change anyone's mind about using it?

That is the key question once that trial data comes in. Again, a Paxlovid partial failure may provide a small opening for EDP-235 but ENTA needs a money bags to fund the trial. Another question is if ENTA wins their lawsuit against PFE for patent infringement by Paxlovid and gets a decent cash settlement and a percentage of future sales, will ENTA consider funding the trial themselves? If so, will PFE decide it is worth it to buy ENTA rather than pay a percentage of future sales?