Tuesday, May 09, 2023 1:15:17 AM
I listened to the CC and the key points, at least to me were.
Enough cash to take ENTA into 2026. This doesn’t model ENTA running their own phase 3 and they aren’t looking to do so. The goal is now and has always been to partner. Looking for partnership for phase 3 as their plan has never been to run their own phase 3. Mentioned phase 2 for long Covid but that will likely be self-funded and run but nothing is set right now.
FDA doesn’t approve Covid drugs aren’t based on viral load changes. It is symptom relief, reduction of hospitalizations and deaths.
Why would symptoms improve with EDP-235 but not really viral load? They speculated that EDP-235 has a higher tissue distribution levels (EC50 & EC90) than Paxlovid but measurements only in the nasal cavity. Effect of EDP-235 on different viral compartments, lung, heat etc could explain systemic symptoms improved with EDP-235 without showing better viral clearance in nasal swabs. It would be difficult to assess these other compartments. Also talked about the much more rapid viral clearance in the nasal swabs in placebo. Nasal swabs only measure viral RNA levels, not active virus that can trigger inflammation.
Question about viral rebound. The analyses haven’t been completed.
Question about EDP-514. looking at other data sets, external assets. No mention of another internal drug.
EDP-323 polymerase inhibitor for RSV. Phase I data safety, tolerability and pharmacokinetics due next month. Challenge study would be next assuming positive data.
Recent ENTA News
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 05/08/2024 08:37:27 PM
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