Biotech Values

[DewDiligence]

PFE starts_phase-2/3_trial_of_COVID_antiviral, PF-07321332, an oral protease inhibitor, in post-exposure prophylaxis:

https://finance.yahoo.com/news/pfizer-starts-global-phase-2-104500629.html

Pfizer today announced the start of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study to evaluate the investigational novel oral antiviral candidate PF-07321332, co-administered with a low dose of ritonavir, for the prevention of COVID-19 infection. This Phase 2/3 trial is…enrolling individuals who are at least 18 years old and live in the same household as an individual with a confirmed symptomatic SARS-CoV-2 infection.

The Phase 2/3 EPIC-PEP trial is a randomized, double-blind, placebo-controlled study and will enroll up to 2,660 healthy adult participants aged 18 and older. Participants will be randomly assigned (1:1:1) to receive PF-07321332/ritonavir or placebo orally twice daily for 5 or 10 days. The primary objective will assess safety and efficacy for the prevention of confirmed SARS-CoV-2 infection and its symptoms through Day 14.

…In addition to this study, the global EPIC program consists of multiple ongoing clinical trials, including one in SARS-CoV-2 infected patients who are at high risk of severe illness (including hospitalization or death), which began in July 2021, and another in infected patients who are at standard risk (i.e., do not have risk facstors for severe illness), which began in August 2021.

Listings for the three phase-3 trials are at:

https://www.clinicaltrials.gov/ct2/show/NCT05047601 (post-exposure prophylaxis — the trial that started today)

https://www.clinicaltrials.gov/ct2/show/NCT05011513 (infected low-risk patients)

https://www.clinicaltrials.gov/ct2/show/NCT04960202 (infected high-risk patients)