The FDA has notified Fulcrum Therapeutics (NASDAQ:FULC) that it may proceed with initiating a Phase 3 trial of losmapimod in higher-risk hospitalized adults with COVID-19.
The Phase 3 LOSVID trial is designed to assess the safety and efficacy of a 15 mg twice per day oral dose of losmapimod compared to placebo for 14 days on top of standard of care in approx. 400 patients.
The primary endpoint is the proportion of patients who progress to death or respiratory failure by day 28.
Top line data are expected in Q1 2021.
An interim analysis will be conducted in Q4 for futility and sample size re-estimation when ~50% of subjects complete the 28-day visit.
Losmapimod is an orally available selective p38α/β mitogen activated protein kinase inhibitor.
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