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Wednesday, 11/09/2022 8:54:26 AM

Wednesday, November 09, 2022 8:54:26 AM

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ENTA starts phase-2 trial of EDP-235 in non-hospitalized, standard-risk COVID patients:

https://finance.yahoo.com/news/enanta-pharmaceuticals-initiates-sprint-phase-120000085.html

The randomized, double-blind, placebo-controlled study will enroll approximately 200 non-hospitalized, symptomatic patients with mild to moderate COVID-19, who are not at increased risk for developing severe disease. Patients will be eligible to participate if they have had symptoms for five days or less and have not received a SARS-CoV-2 vaccine or been infected with SARS-CoV-2 within 90 days of enrollment.

Patients will receive EDP-235 orally at a dose of 200mg or 400mg or placebo once daily for five days. The primary objective of the study includes evaluation of safety and tolerability, and secondary objectives include the evaluation of virologic endpoints, clinical symptoms and outcomes, and pharmacokinetics.

Data are expected in 1H23. I had been hoping for a pivotal phase-2/3 trial. but either ENTA or the FDA evidently didn’t like that idea.

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