PhaseBio Announces Case Study Highlighting PB1046 Hemodynamic Data Presented at the 14th Pulmonary Vascular Research Institute World Congress
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
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.
PhaseBio is located in
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements.
Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for PB1046 and the potential for PB1046 to be disease-modifying. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.
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Chief Financial Officer
Source: PhaseBio Pharmaceuticals, Inc.