I listened the talk Jeffries today. It was very uplifting to me. Jay Luly stated that there is sufficient EDP-235 for phase 3 trials, which is reassuring. He also explained a big difference in the Shionogi trial and the EDP-235 trial. For the Shionogi trial the number of nucleocapsid positive patients (i.e. previously Covid infected) was in the single digits whereas it was some 70%-80% in the EDP-235 trial. That would explain why an overall virus decline was seen in the overall population in the Shionogi trial and was also seen in the new analysis from ENTA in nucleocapsid negative population in the EDP-235. Looking at only nucleocapsid negative population in the EDP-235 trial is an apples to apples comparison, and should remove any doubt that EDP-235 has potent anti-viral activity. Well, the statistically significant improvement in symptoms for EDP-235, which Paxlovid failed to show in a standard risk population, should have already made that crystal clear. Still it is nice confirmatory bit of data to see even though the FDA wouldn't base any approval on viral reduction in nasal swabs.
The Jeffries interview was fair but tough and pointed. He made it clear that EDP-235 showed symptom relief and Luly reiterated that Paxlovid failed to do so even with a mostly nucleocapsid low population. They talked about IC90 and Luly pointed out the bar has been raised for new drugs as EDP-235 has reaches a much higher drug level with regards to IC90 than Paxlovid, and that likely explains symptom relief. Yes the Jeffries interviewer/host pressed about timelines not only for EDP-235 but for RSV drugs. There was some ballpark figures about the cost of 2 large phase 3 trials for Covid and it was $100-$200 million. Luly did point out the China was experiencing a major surge in Covid cases. Luly refused to get drawn in and make specific comments. Obviously there are no guarantees, but overall I came away more confident about ENTA and about EDP-235 and ENTA.
