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Wednesday, August 03, 2022 10:08:57 AM
"Antiviral treatment for RSV, including EDP-938, has the greatest potential to show optimal efficacy in high-risk populations, as these patients have reduced RSV immunity which manifests in a longer duration of viral shedding and greater disease severity, allowing a bigger window to realize the full potential of EDP-938. Moving forward, our broad clinical development plan will focus on evaluating EDP-938’s potential in populations with the greatest unmet need, namely those who are at high-risk for severe disease, including pediatric patients, immune compromised, and a high-risk adult population."
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Think of covid. Where is the business - what population group? The high risk.
Let me reframe "did not meet the primary endpoint in a Phase 2b clinical trial" as
failed to differentiate the treated group (those intentionally infected) to other healthy.
I think that it's because the normal healthy group recovered so quickly that there was little differentiation between the two groups.
The real question is whether the Enanta RSV drug (EDP-938) will create a differentiated response in the higher risk groups with weakened immune response and more attenuated recoveries.
Look at Paxlovid and covid.
What if you attempted to prove Paxlovid worked by comparing it to groups of covid infected "healthies" who were asympotmatic and who recovered quickly? You could easily conclude that Paxlovid didn't work due to the lack of differentiation.
Here is what the trial did show;
"Final data available from all high-risk patients enrolled in EPIC-HR study (n= 2,246) confirmed prior results of interim analysis showing PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo; no deaths compared to placebo in non-hospitalized, high-risk adults with COVID-19"
That's the way that I interpreted it.
Enanta took data where they could get it, but by no means was it going to be a trial that was going to be where the bulk of their business would be or on a group that would see the most benefit.
That's my quick take on it and there are many here far more sharp than I am.
I could be wrong. But I have to wonder if many on twitter who called the trial results a whiff or a failure are reading it right. Like you, I'm curious myself of other's interpretation of the results.
https://clinicaltrials.gov/ct2/show/NCT03691623?term=EDP-938&cond=RSV&draw=2&rank=2
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