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Re: alertmeipp post# 3422

Wednesday, 11/13/2024 4:34:04 PM

Wednesday, November 13, 2024 4:34:04 PM

Post# of 6052
I'm not suggesting anything I posted simply because i found it a curious coincidence that the ark bio drug had a new trial listing for a QTC trial that was posted within a week of ENTA's posting their QTC trial. I honestly didn't know the current status of ziresovir, and still don't really ark is private and not much out there. However I don't think you plan a QTc unless you are hoping to progress into a phase 3, and they are a competitor, so worth keeping an eye on IMO (along w Shionogi L inhibitor which is going to have challenge data this quarter). Ark lists their drug as completing phase 2 ex china so I don't think this is any big surprise and I actually don't think this is at all related to the weakness in ENTA. If anything if ARK is having discussions w FDA regarding a phase 3 might be nice for ENTA - let them hash it out and ENTA can then align w FDA faster if they progress into phase 3 as well
I added some detail from their phase 3 trial bc the authors echo ENTA management regarding limitations of their drug and the probable need for further data to confirm a clinically meaningful effect - something an editorial in NEJM mentions as well.
This trial is also a good frame of reference for virology (.6 log difference relative to PBO). On the clinical side will be difficult to show much but you never know. Ark did show shorter NICU stay on drug with an N=12 admitted to NICU so it's possible something can come up even though the ENTA trial is much smaller (Ark notably had nothing on oxygen requirements, hospital stay, etc. so I assume there was no difference relative to PBO)
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