Malvern, PA, August 8, 2016 — PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on biopolymer-based drugs for orphan, cardiopulmonary and metabolic diseases, today announced the dosing of the first patients in Part One of a Phase 2a clinical study of PB1046, a once-weekly vasoactive intestinal peptide (VIP) receptor agonist in development for the treatment of cardiopulmonary disorders. Part One will assess PB1046 in adult subjects with stable heart failure with reduced ejection fraction. Part Two, which PhaseBio expects to initiate later in 2016, will examine PB1046 in subjects with cardiac dysfunction secondary to Duchenne muscular dystrophy.
“There is a clear need for heart failure treatments that both alleviate symptoms and slow or reverse disease progression,” said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. “We look forward to building on our compelling preclinical data in models of heart failure, and the positive data from our Phase 1 studies, which demonstrated the safety and tolerability of PB1046 at efficacious doses in patients with hypertension.”
Part One is a randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, and pharmacokinetic and pharmacodynamic response following four weeks of once-weekly subcutaneous injections of PB1046 in 28 adults with heart failure. Dose levels shown to be safe and well-tolerated in Part One will be selected for evaluation in Part Two of the study.
Read more: http://www.phasebio.com/pages/news/releases/PhaseBioAnnouncesDosingofFirstPatientsinTwo-PartPhase2aStudyofPB1046inCardiopulmonaryDi.php