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PhaseBio Pharmaceuticals said today it won a $2.8 million Fast Track Small Business Innovation Research (SBIR) grant from the NIH toward clinical development of its lead candidate PB1046 for pulmonary arterial hypertension (PAH). PB1046 is a first-in-class, sustained-release vasoactive intestinal peptide (VIP) analog already under study in an ongoing Phase I clinical trial ( NCT03315507 ). The trial, PB1046-PT-CL-000, is an open-label, dose-titration study designed to assess the safety, tolerability, and hemodynamic effects of individually dose-titrated PB1046 injected weekly over 8 weeks in adults with PAH who have a permanently implanted hemodynamic monitor (CardioMEMS™ HF System) in the distal pulmonary artery. The Phase I portion of the grant will fund the ongoing exploratory trial, while the Phase II portion will support a larger, Phase II trial in PAH set to launch by mid 2018, PhaseBio said. PB1046 is a once-weekly VIP receptor agonist designed to ...
Original Article: PhaseBio Wins $2.8M SBIR Grant to Advance Lead CandidateNEXT ARTICLE
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of affected individuals. Symptoms can range from mild breathles...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...