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PhaseBio blames COVID-19 disruption as cardiovascular study axed

PhaseBio is blaming the impact of COVID-19 on manufacturing for the decision to end development of a mid-stage cardiovascular disease treatment.

The Malvern, Pennsylvania-based biotech reported that pemziviptadil will be axed from its pipeline on Tuesday. The therapy had been in a phase 2b trial for patients with pulmonary arterial hypertension (PAH), a type of high blood pressure that impacts the arteries in the lungs and heart.

PhaseBio blamed COVID-19’s disruption on manufacturing, associated drug supply and the rate of enrollment in the study. The company will take a look at the data collected from the trial, dubbed VIP, to figure out an appropriate path forward for pemziviptadil.

This could include “an improved product presentation and simplified product dosing” in a later trial.

RELATED: PhaseBio’s Brilinta reversal agent wins midstage test as biotech awaits key data on emergency patients

“With the continued impact of the COVID-19 pandemic on this phase 2b clinical trial, we believe a full evaluation of the program makes sense at this time and that any positive data generated could help galvanize support for the future development of pemziviptadil,” said PhaseBio CEO Jonathan Mow in a statement.

More than 50% of the study’s target population had been enrolled when PhaseBio decided to ax it. The therapy had been administered in five clinical trials to more than 100 patients with cardiovascular or cardiopulmonary diseases, the company said.

Mow said that after completion of the final analysis of the trial, PhaseBio will “evaluate the potential for a future trial.”

“We continue to believe pemziviptadil is a potentially valuable asset for the treatment of PAH and other diseases,” he said. 

RELATED: PhaseBio taps a manufacturing partner as it eyes 2022 filing for Brilinta-reversing drug

Resources will be reprioritized to PhaseBio’s Brilinta reversal agent, which posted a phase 3 win back in November. The study found that bentracimab, also known as PB2452, reversed the effects of AstraZeneca’s stroke medicine Brilinta in emergency situations. The company will use the repurposed funds for commercialization efforts for that therapy.

Other funds will be used to advance PhaseBio’s pipeline, including the resistant hypertension med PB6440.

Pemziviptadil had been granted orphan drug designations for PAH and cardiomyopathy associated with Duchenne Muscular Dystrophy by the FDA. The therapy has been associated with activity in the DMD indication and cystic fibrosis in preclinical research, but PhaseBio does not currently have those indications listed on its pipeline.

Annalee Armstrong

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