PhaseBio’s move to suspend its Phase IIb trial of pemziviptadil is due to the effect of COVID-19 on manufacturing, associated drug supply, and the rate of enrollment in the study.
On Wednesday, PhaseBio Pharmaceuticals announced the voluntary ending of its Phase IIb trial of pemziviptadil (PB1046) in pulmonary arterial hypertension. However much of the trial has commenced, the company will still analyze the data available to determine a course moving forward.
PhaseBio’s move to suspend its Phase IIb trial of pemziviptadil is due to the effect of COVID-19 on manufacturing, associated drug supply, and the rate of enrollment in the study.
On the basis of the results from the available data, the company plans to include an improved product presentation and simplified product dosing in a subsequent trial. With the suspension of the Phase IIb trial, the company will be reprioritizing resources and capital towards pre-commercialization activities of bentracimab (a drug to reverse the anti-platelet effects of ticagrelor) and the advancement of other pipeline programs, including PB6440, another PhaseBio candidate, a selective aldosterone synthase inhibitor for treating patients with resistant hypertension.
The Phase IIb trial of pemziviptadil, known as the VIP trial (Vasoactive Intestinal Peptide in adult patients with pulmonary arterial hypertension), had successfully enrolled more than 50% of the study’s target population.
Pemziviptadil, is a novel, subcutaneously injected VIP analogue. Biologically, is a recombinant fusion protein composed of VIP and PhaseBio’s proprietary elastin-like polypeptide (ELP) biopolymer. Based on the key observations from the pharmacokinetic profile of pemziviptadil from the PhaseBio clinical trials, it was seen that fusing VIP to ELP resulted in both a prolonged absorption profile and a longer circulating half-life. This implied that the drug could be given safely on a once-weekly dosing.
Pemziviptadil was in Phase II development for the treatment of PAH. To date, more than 100 patients with cardiovascular or cardiopulmonary diseases in five clinical trials in the United States have been given pemziviptadil. Considering these observations, the US Food and Drug Administration had granted pemziviptadil, the designation of an orphan drug for the treatment of pulmonary arterial hypertension (WHO Group 1 Pulmonary Hypertension) and cardiomyopathy associated with Duchenne Muscular Dystrophy.
Commenting on the current state of affairs, Jonathan Mow, Chief Executive Officer, PhaseBio Pharmaceuticals was quoted saying, “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. Upon completion of the final analyses of the pemziviptadil trial, we will evaluate the potential for a future trial of pemziviptadil. We continue to believe pemziviptadil is a potentially valuable asset for the treatment of pulmonary arterial hypertension and other diseases.”
