Shares in PhaseBio Pharmaceuticals (PHAS) plunged 9.5% on Friday after the company announced that it has decided to discontinue its Covid-19 trial for treatment pemziviptadil.
“Ater a strategic review of the VANGARD clinical trial that included an assessment of the evolving COVID-19 treatment landscape, feedback from the U.S. Food and Drug Administration (FDA) and an interim analysis of the VANGARD study data, it has elected to discontinue the trial” the company stated.
PHAS noted that pemziviptadil was generally well tolerated and there was no adverse safety signal reported in the VANGARD trial.
PhaseBio recently submitted a revised VANGARD trial protocol and received feedback from the FDA regarding the regulatory and development path in COVID-related acute respiratory distress syndrome (ARDS).
For pemziviptadil use in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and ARDS, the FDA highlighted the likely need for additional clinical trials with sufficient sample size to adequately assess mortality risk.
Based on this feedback, PhaseBio determined that it would be unlikely that the 70 patients targeted for enrollment in each of the VANGARD trial’s treatment arms would be sufficient in size to adequately evaluate mortality and that at least one additional clinical trial with a mortality endpoint, which would require significantly more patients, would be required.
At the same time, based upon its analysis of the first 25 patients enrolled, PhaseBio did not observe any data trends in the 40 mg or 100 mg pemziviptadil-treated arms of the trial that suggested a reasonable probability of achieving the primary efficacy endpoint.
As a result, the ongoing Phase 2b trial of pemziviptadil in patients with PAH (pulmonary arterial hypertension) is expected to quickly resume enrollment after a pause related to the impacts of the COVID-19 pandemic and re-prioritization of drug supply to the VANGARD trial. Results from this trial are expected to be reported in the second half of 2021.
Shares in PHAS are now trading down 49% year-to-date. However the stock scores a bullish Strong Buy Street consensus with five back-to-back buy ratings. The average analyst price target also indicates significant upside potential from current levels.
“The main value driver for PHAS remains bentracimab (PB2452) which is in a Phase III study for reversal of Brilinta. The trial will include a ~100 patient interim readout on track for 2021 which intended to support a BLA filing for accelerated approval” explains Needham analyst Chad Messer.
He reiterated his buy rating and $18 price target on PHAS following the update. The analyst notes that PB2452 has already received PRIME designation from the EU in February and has breakthrough designation in the US. (See PHAS stock analysis on TipRanks)