PhaseBio pulls the plug on pemziviptadil COVID-19 study

• PhaseBio Pharmaceuticals (NASDAQ:PHAS) slips 5% in premarket on light volume, after it announced to discontinue VANGARD trial evaluating pemziviptadil (PB1046) as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome.
• Based on feedback from the FDA, the company determined that the 70 patients targeted for enrollment in each of the VANGARD trial’s treatment arms would be insufficient in size to adequately evaluate mortality and that at least one additional clinical trial with a mortality endpoint, would be required.
• After an interim analysis of the first 25 patients, PhaseBio did not observe any data trends in the 40 mg or 100 mg pemziviptadil-treated arms suggesting a reasonable probability of achieving the primary efficacy endpoint. Pemziviptadil was generally well tolerated, and no safety concerns were identified.
• The ongoing Phase 2b trial of pemziviptadil in patients with pulmonary arterial hypertension (PAH) is expected to resume enrollment after a pause related to COVID-19 pandemic and re-prioritization of drug supply to the VANGARD trial. To date, around 1/3rd of the patients targeted for enrollment have completed the initial 16 week protocol. Results are expected in 2H 2021.
• https://seekingalpha.com/news/3625335-phasebio-pulls-plug-on-pemziviptadil-covidminus-19-study