PhaseBio Pharmaceuticals, Inc. announced presentation of data from a Phase 1b 2a pilot study highlighting three patients who received pemziviptadil (PB1046), the company's first-in-class, sustained-release vasoactive intestinal peptide (VIP) analogue for the treatment of pulmonary arterial hypertension (PAH). The data, which were presented virtually at the 15th Pulmonary Vascular Research Institute (PVRI) World Congress on January 27, 2021, continue to highlight the favorable safety and tolerability profile of pemziviptadil, as well as clinically-meaningful, long-term improvement of six-minute walk test (6MWT) distance for one patient after eighteen months of treatment. Additionally, the data demonstrate stability in functional status with no clinically-meaningful deterioration for two patients at two and six months after treatment. Hemodynamic data from this same trial were presented at the 14th PVRI World Congress in early 2020. The patients participated in PhaseBio's Phase 1b 2a pilot study, which evaluated the multi-dose safety, pharmacokinetics (PK) and VIP-based pharmacodynamic effects of pemziviptadil in three PAH patients who have a permanently implanted hemodynamic monitor (CardioMEMS HF System), a device placed in the pulmonary artery that continuously measures heart rate along with systolic and diastolic pressures. Pemziviptadil was administered subcutaneously on a weekly basis for eight weeks (extended due to subjective improvements) at dose levels previously tested in Phase 1. All three patients completed the study with no drug-related serious adverse events associated with study drug discontinuation and pemziviptadil appeared to be well tolerated. New efficacy data in this analysis included 6MWT distance, which improved (by +78 meters, 17% change from baseline) after 18 months of treatment in one patient, a 29 year old, while showing no signs of clinically-meaningful deterioration in a 61 year old patient after two months of therapy (-9 meters, -2% change from baseline) or in a 74 year old patient after 6 months of treatment (+16 meters, 7% change from baseline). In an ongoing 16-week randomized, double-blind, Phase 2b clinical trial of pemziviptadil in PAH patients (the VIP trial), PhaseBio is measuring pulmonary vascular resistance and 6MWT distance among other key efficacy endpoints in approximately 60 patients. Pemziviptadil, a novel, subcutaneously-injected vasoactive intestinal peptide (VIP) analogue, is a recombinant fusion protein composed of VIP and PhaseBio's proprietary elastin-like polypeptide (ELP) biopolymer. Based on the pharmacokinetic profile of pemziviptadil observed in 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 is in Phase 2 development for the treatment of pulmonary arterial hypertension (PAH). PhaseBio expects to report initial data from the Phase 2b trial in PAH in the second half of 2021. 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 dystrophinopathies.