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willyw

01/05/24 1:38 PM

#250250 RE: vinmantoo #250249

Years ago I was in a Phase 3 Vertex Hep C Trial. The lead drug was then called Telaprevir and it had a serious AE of causing Stevens-Johnson Syndrome (a very serious rash) in a reasonable number of patients. It scared the hell out of many patients- and frankly some doctors when first seen. A trial participant with the rash said the doctors weren't sure whether to treat him or run from him and get a biohazard suit first. : )

The thing is that after the cure rate and efficacy was shown to be well above the current standard of care and 2) that the side effects could be managed suddenly what appeared to look like a loser turned into a winner. (from a 45% SOC to about a 75% cure rate with the new antiviral)

As a sidebar to this story, the much larger Shering-Plough competitor ended up barely beating the tiny Vertex startup to approval with a very comparable drug (boceprevir).
In this case, The Goliath didn't exactly best David but it had a number of advantages over the smaller Vertex.
This seems somewhat analogous to PFE and ENTA.

Getting to my point, I rather wonder if Enanta had attempted to find something that would have provided the means to provide greater differentiation to SOC.
I wonder if a second phase 2 trial might have been attempted, and I wonder if a little more data on the superiority over the current SOC in covid might have been shown there might have been greater interest in a partnership.

I feel this is analogous to the situation with RSV. A challenge study in which "healthies" rather easily shrug off an RSV infection is less likely to be compelling when contrasted to the differentiation provided in a peds or immune compromised groups.
So I partially see this as a problem- not with the drug, but with the public perception of the performance/efficacy of EDP 235.

By the way..... that Vertex trial which had trouble enrolling patients immediately after the serious rash problem?
As soon as the data showed the higher cure rate and that the sides could be controlled- Vertex had no problems with Phase 3 enrollment.
It was the best *proven* HCV treatment on earth in that moment.

I just wonder what might have better showcased EDP-235's potential?
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willyw

01/07/24 1:32 PM

#250286 RE: vinmantoo #250249

A viral social media post claims 1 in 3 people will get COVID this winter.
https://www.yahoo.com/news/viral-social-media-post-claims-045511438.html

A viral social media post based on data from the U.S. Centers of Disease Control and Prevention is calling this surge the second-biggest COVID wave in the history of the U.S. — after the omicron surge from late 2021 to early 2022, which infected more people than even the early days of the pandemic.

https://covid.cdc.gov/covid-data-tracker/#datatracker-home
Per the CDC hospitalizations are up 20%
from the week of Dec 24 to Dec 30 2023.
About 35K hospitalizations/ week?
Some are asserting that we are back to pandemic levels.