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10/27/24 1:01 AM

#3363 RE: dewophile #3362

Thank you for sharing dewophile… I will study this information. I keep learning; I am impressed with Enanta’s management team. Drs. Luly and Keiffer work well together.
I am also fascinated with how the patent lawsuit is unfolding and how the parties duel over language and definitions. Seems like both sides have won small victories to date.
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alertmeipp

10/27/24 8:20 PM

#3364 RE: dewophile #3362

dewophile and DewDiligence - to a layman like me, ENTAs RSV program seems to be more advanced and promising than others, so any particular reasons they haven’t been able to secure a nice partnership or buyout for RSV?

PFEs spent 500mm for an inferior (now bursted) program, ENTAs program should worth at least that?

Actually, same thing for 235, COVID isn’t dead, just not in news daily anymore. COVID drug still take in billions of sales, why can’t ENTA get a partnership for it?

Is there some weakness in their deal making strategy?

The insider owns significant shares, do they get too greedy because of that?
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dewophile

11/11/24 9:08 PM

#3414 RE: dewophile #3362

Re Ziresovir (Ark bio F inhibitor)

They are planning a QT trial of the drug based on this listing, which suggests they are gearing up for a phase 3 - probably of a size and scope and with endpoints* that will meet US and EU regulators' satisfaction. I would also assume they study the drug in infants who are not yet hospitalized

https://clinicaltrials.gov/study/NCT06591845?term=ziresovir&aggFilters=status:not&rank=1

*The clinical endpoint used in the phase 3 trial was the "Wang bronchiolitis score". The authors concede " The main limitation of this trial is the use of the Wang bronchiolitis clinical score, a clinical tool that has not been fully validated in studies of RSV infection". Probably need some harder endpoints. The duration in the NICU was the only one I could find (see supplement); median 3 days ziresovir and 8 days placebo, but numbers were very small with N=9 tx and N=3 placebo.
Note that viral loads also didn't start to decline versus placebo until after day 2, which is probably related to the MOA. From the discussion:
"The antiviral effect of ziresovir was observed by day 3. A delayed effect in reducing the viral load is consistent with the mode of action of F protein inhibitors, which inhibit virus entry but have no direct effect on intracellular virus."