Biotech Values

[DewDiligence]

ENTA COVID-19 update—postpones ARGON phase-2b trial of EDP-305 in NASH—a trial I did not want ENTA to undertake (#msg-153275794, #msg-152426231):

https://www.enanta.com/investors/news-releases/press-release/2020/Enanta-Provides-Update-on-Clinical-Development-Activities-During-COVID-19-Pandemic/default.aspx

With the safety of our clinical trial participants in mind, coupled with a desire to alleviate many of the resource constraints at clinical trial sites, Enanta has proactively decided to make adjustments to some of our clinical programs,” said Jay R. Luly, President and Chief Executive Officer of Enanta. “While we were poised to begin dosing the ARGON-2 Phase 2b NASH study this week, we have paused recruitment and dosing in this study, and we are pausing further recruitment in Part 2 of our Phase 1a/1b study of EDP-514 in nuc-suppressed hepatitis B (HBV) patients, which initiated earlier this quarter.”

Dr. Luly added, “As planned, we are continuing to prepare to initiate our two Phase 2 respiratory syncytial virus (RSV) studies of EDP-938 in pediatric and transplant patients later this year. We also are hopeful we will be able to conduct our Phase 1b study of EDP-514 in viremic HBV patients, as well as our first-in-human study of EDP-297 for NASH, substantially on schedule. [EDP-297 is the follow-on FXR compound that looks much better than the first-generation, EDP-305.]

Further, we have already completed the RSV season in the U.S. and are continuing with plans to shift our RSVP study to the Southern Hemisphere.

We do not anticipate any supply disruption for any of these trials. All of our plans are subject to change, though, as the COVID-19 pandemic rapidly evolves, but fortunately we have sufficient cash resources to bridge us across the current COVID-19 disruption. Meanwhile, in the coming weeks we plan to announce data from our INTREPID study of EDP-305 in patients with primary biliary cholangitis.”

The delay in the HBV program will hurt, but the RSV program may be spared from undue impact. In NASH, my hope is that the ARGON phase-2b trial of EDP-305 will be scrapped entirely, allowing EDP-297 to become the lead NASH compound.

All told, the above doesn't sound as bad as it might have.