Phasebio Pharmaceuticals, Inc. Provides Pemziviptadil Program Update
December 21, 2021 at 08:00 am EST
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PhaseBio Pharmaceuticals, Inc. announced that the company is voluntarily ending its Phase 2b trial of pemziviptadil (PB1046) in PAH due to COVID-19 impacts on manufacturing, associated drug supply and the rate of enrollment in the study. The company will analyze the trial data to determine an appropriate path forward for the program, which depending on the results could include an improved product presentation and simplified product dosing in a subsequent trial. With the suspension of the Phase 2b trial, the company will reprioritize resources and capital towards pre-commercialization activities of bentracimab and the advancement of other pipeline programs, including PB6440 for resistant hypertension. The Phase 2b trial of pemziviptadil, named the VIP trial (Vasoactive Intestinal Peptide in adult patients with pulmonary arterial hypertension), had successfully enrolled more than 50% of the studys target population. Pemziviptadil, a novel, subcutaneously injected VIP analogue, is a recombinant fusion protein composed of VIP and PhaseBios proprietary elastin-like polypeptide biopolymer. Based on the pharmacokinetic profile of pemziviptadil observed in PhaseBio clinical trials, the fusion of VIP to ELP results in both a prolonged absorption profile and a longer circulating half-life, enabling once-weekly dosing. Pemziviptadil was in Phase 2 development for the treatment of PAH. To date, pemziviptadil has been administered to more than 100 patients with cardiovascular or cardiopulmonary diseases in five clinical trials conducted in the United States. The FDA has granted pemziviptadil orphan drug designation for the treatment of pulmonary arterial hypertension (WHO Group 1 Pulmonary Hypertension) and cardiomyopathy associated with Duchenne Muscular Dystrophy.
PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of novel therapies for cardiovascular diseases. Its lead product candidate, bentracimab (also known as PB2452), is a novel reversal agent for the antiplatelet drug ticagrelor. Ticagrelor is an antiplatelet therapy widely prescribed to reduce the rates of death, heart attack and stroke in patients with acute coronary syndrome (ACS), or who have previously experienced a heart attack. Ticagrelor binds to platelets to prevent them from forming blood clots that could restrict blood flow. The Company is also developing its preclinical product candidate, PB6440, an oral selective aldosterone synthase inhibitor for treatment-resistant hypertension. The Company is leveraging ELP biopolymer technology to evaluate additional preclinical and discovery-stage candidates. Its focus is on proteins and peptides that are scientifically or clinically validated.