Friday, November 25, 2022 11:37:36 AM
It is irrelevant whether or not I know how to make a drug.
It is irrelevant whether or not I know a lot about clinical trials.
If you say so but personally I think you a recent first time arrival. I suggest you read more about Covid, Paxlovid and EDP-235 so you can get up to speed and raise reasonable issues.
Back to your irrelevant comparison to RSV. There has never been a drug that has been clinically proven to inhibit RSV enough to help infected people enough to get FDA approval. That means we don't yet no how much inhibition of RSV in vivo is needed to sufficiently improve patient prognosis, nor do we know which RSV target would work best or even work well. ENTA's EDP-938 showed real promise in a challenge trial but while it lowered viral titer in infected people, it didn't statistically reduce symptoms. ENTA is testing it in high risk patient. We will see.
In stark contrast, Paxlovid works quite well in patients. We know how much drug is needed to improve prognosis of infected patients. We also knows that Paxlovid targets the Covid protease. EDP-235 targets the same protease but inhibits at much lower drug levels. Unlike Paxlovid, EDP-235 also doesn't need a drug pump inhibitor, making it better (safer?) for patients who are on other drugs. We know from the phase I trial of EDP-235 that its plasma levels are several fold high than needed to inhibit Covid, and its ~1 day half-life means EDP-235 should remain at inhibitory concentrations for several days after treatment stops. That may make it better at preventing Covid rebound than Paxlovid. There are no guarantees. I did mention potential safety issues could crop up in any trial, and that goes for EDP-235 even though the safety data looked good in the small phase I safety trial. I also stated the short treatment period, 5 days, makes safety issues less likely.
I have covered this issue sufficiently so I am done with this thread.
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