February 10, 2020
PhaseBio Announces Case Study Highlighting PB1046 Hemodynamic Data
Presented at the 14th Pulmonary Vascular Research Institute World Congress PhaseBio Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced presentation of data from a patient who received more than 18 months of treatment with PB1046.
The company’s first-in-class, sustained-release vasoactive intestinal peptide (VIP) analogue being evaluated for the treatment of patients with pulmonary arterial hypertension (PAH). The data, which were presented at the 14th Pulmonary Vascular Research Institute (PVRI) World Congress held in Lima, Peru, from January 30th through February 2nd 2020, demonstrate clinically-meaningful improvements in all of the hemodynamic parameters assessed, which were sustained for up to three months after the last dose was administered.
The patient was part of PhaseBio’s Phase 1b/2a pilot study which evaluated the multi-dose safety, pharmacokinetics (PK) and VIP-based pharmacodynamic effects of PB1046 in three PAH patients who have a permanently implanted hemodynamic monitor (CardioMEMS™ HF System), a device placed in the pulmonary artery (PA) which continuously measures heart rate along with systolic and diastolic pressures. PB1046 was administered subcutaneously on a weekly basis for eight weeks at dose levels previously tested and observed to have a favorable safety profile. All three patients completed the eight-week study with no drug-related serious adverse events and PB1046 appeared to be well tolerated with only mild injection site erythema. In one patient, the subject of the case study, treatment was extended for a total of 18 months, based on continued improvements in hemodynamic parameters. The CardioMEMS monitoring system detected reductions in mean PA pressure and total pulmonary resistance and increases in stroke volume and cardiac output without an increase in heart rate with PB1046.
“We were pleased to see sustained positive long-term effects in an adult patient with PAH who had been treated with PB1046,” said Raymond Benza, MD, cardiologist at the Allegheny Health Network in Pittsburgh, Pennsylvania. “We believe these data validate the continued evaluation of PB1046 in the ongoing Phase 2b clinical trial and underscore its potential to be a once-weekly treatment for PAH, a progressive and life-threatening orphan disease with no known cure.”
PB1046, 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 PB1046 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. In addition to VIP-mediated vasodilation, PB1046 may suppress the adverse remodeling of blood vessels and increase cardiac contractility and relaxation. PB1046 has been administered to more than 70 patients with hypertension or a history of cardiovascular disease in three Phase 1/2 clinical trials conducted in the U.S., with no drug-related serious adverse events to date.
The U.S. Food and Drug Administration has granted PB1046 orphan drug designation for the treatment of PAH (WHO Group 1 Pulmonary Hypertension) and cardiomyopathy associated with dystrophinopathies.
[Originally posted by PHASE Bio — Feb 4, 2020]