PhaseBio Expands Clinical Development of Vasomera for the Treatment of Cardiopulmonary Diseases

PhaseBio Pharmaceuticals, a clinical-stage biopharmaceutical company focused on diabetes and cardiovascular diseases, today announced the successful completion of a Phase 1 trial of Vasomera™ (PB1046), the first once-weekly investigational, VPAC2 selective receptor agonist for the treatment of cardiopulmonary diseases. This multi-center, randomized, double-blind, placebo-controlled trial demonstrated the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) response of single ascending subcutaneous (SC) doses of Vasomera in 40 patients. Trial results showed PD activity that was supportive of a once-weekly dosing regimen that could allow for chronic use in a home setting.

“Vasomera offers a unique combination of activities that not only treats the symptoms, but potentially alters the underlying pathophysiology of cardiopulmonary diseases,” said Chris Prior, Ph.D., chief executive officer, PhaseBio. “We are pleased with the progress of this program. The completion of this trial not only represents an important milestone for Vasomera, but also provides validation of our elastin-like polypeptide technology platform with three distinct clinical product candidates in development.”

In this Phase 1 trial, Vasomera was generally well tolerated with no clinically relevant cardiovascular safety signals identified. The Company plans to submit the full data set to an upcoming major medical meeting.

Initiation of Phase 1 Trial with Vasomera Intravenous (IV) Administration

Based on the clinical results of the Phase 1 trial evaluating SC Vasomera, PhaseBio has initiated a second Phase 1 trial to evaluate the safety, tolerability and PK/PD response of single ascending doses of short-term IV-infused Vasomera. IV administration of Vasomera would enable use in an acute hospital setting, with the goal of preserving or improving hemodynamic function in heart failure and reducing the incidence of re-hospitalization.

The trial is expected to enroll up to 32 patients and will evaluate the acute impact of Vasomera on hemodynamic function using echocardiographic analyses. It will also provide support for the development of Vasomera for treatment of acute heart failure as well as pulmonary arterial hypertension (PAH). The trial is expected to complete in the third quarter of 2013.


Source: PhaseBio

Published on : Tue, 18 Jun 2013


Print as PDF
PhaseBio Pharmaceuticals, a clinical-stage biopharmaceutical company focused on diabetes and cardiovascular diseases, today announced the successful comple

No comment


Please login to leave a comment...

Highlighted Products