PhaseBio Announces Dosing of First Patient in Phase 2b Clinical Trial of PB1046 in Pulmonary Arterial Hypertension
The randomized, double-blinded, parallel-group Phase 2b trial will assess the safety, tolerability and efficacy of PB1046 injected subcutaneously once weekly in approximately 60 PAH patients. The trial will evaluate the effects of PB1046 on pulmonary hemodynamics and exercise tolerance as measured by the six-minute walk test, an important clinical endpoint that the
“PB1046 leverages our ELP technology to harness the positive therapeutic effects and extend the half-life of native human VIP, which has previously been limited in its application as a therapeutic by its rapid degradation and potential for gastrointestinal side effects,” said
The Phase 2b trial of PB1046 in PAH is supported in part by a
Additional information on the trial can be found on www.clinicaltrials.gov using the identifier NCT03556020.
About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a progressive and life-threatening orphan disease caused by abnormal constriction and adverse remodeling of the arteries in the lungs, leading to chronically elevated blood pressure in the pulmonary arteries. This increased pressure restricts blood circulation through the lungs, resulting in poor oxygenation, abnormal strain on the heart’s right ventricle and underfilling of the left ventricle. Over time, the remodeling worsens as inflammatory cells are recruited. This leads to tissue scarring and fibrosis, which results in severe restriction of blood flow, increasing the risk of developing life-threatening blood clots, heart failure and premature death. None of the approved treatment options is curative and long-term prognosis remains poor.
PB1046, a novel, subcutaneously-injected VIP analogue, is a recombinant fusion protein composed of VIP and PhaseBio’s proprietary 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 60 patients with hypertension or a history of cardiac disease in three Phase 1/2 clinical trials conducted in the U.S., with no drug-related serious adverse events to date.
PhaseBio is located in
Chief Financial Officer
Source: PhaseBio Pharmaceuticals, Inc.