“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
