Biotech Values

[DewDiligence]

ENTA announces SARS-CoV-2_protease_inhibitor, EDP-235:

https://finance.yahoo.com/news/enanta-pharmaceuticals-announces-nomination-clinical-110000908.html

“As the virus continues to rapidly mutate, there remains a need for an oral, direct-acting antiviral that potently inhibits viral replication… EDP-235 has been specifically designed to target conserved regions in the active site of a viral enzyme essential for SARS-CoV-2 replication, so we do not expect mutations in the spike protein to affect the activity of our candidate.

EDP-235 potently and selectively inhibits SARS-CoV-2 replication in multiple cellular models, including primary human airway epithelial cells, with an EC90 of 33nM. EDP-235 retained activity against protease enzymes from currently circulating SARS-CoV-2 variants. Additionally, EDP-235 has a clean preclinical safety profile and has demonstrated a high barrier to resistance. Importantly, EDP-235 has excellent lung distribution in rats and demonstrates properties supportive of once daily oral dosing, in contrast to other protease inhibitors currently in development. Furthermore, EDP-235 has shown activity against other coronaviruses, providing the opportunity to potentially treat other infections that may emerge in the future.

Enanta…expects to initiate a Phase 1 single and multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of EDP-235 in approximately 75 healthy volunteers in early 2022.