Malvern, PA, November 9, 2015 — PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company and leader in the field of biopolymer-based drugs focused on developing treatments for metabolic and specialty cardiopulmonary disorders, today announced the initiation of a Phase 2a clinical study of PE0139, its novel, super-long-acting basal insulin for the treatment of hyperglycemia associated with diabetes dosed as a once-weekly subcutaneous injection.
The multicenter, randomized, double-blind, placebo-controlled, multiple sequential ascending dose study will assess the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic response of PE0139 injection in adults with type 2 diabetes mellitus treating up to 50 subjects for six weeks.
“This Phase 2a study represents a key milestone for PhaseBio as we advance the development of PE0139, which has the potential to be the first once-weekly insulin to market,” said Jonathan P. Mow, Chief Executive Officer of PhaseBio. “PE0139 was well tolerated in a Phase 1 study and demonstrated a flat PK profile essential for once-weekly dosing. We look forward to continuing to evaluate PE0139 with the goal of providing better treatment options for people with diabetes.”
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PE0139 is a novel, super-long-acting basal insulin for the treatment of hyperglycemia associated with diabetes dosed as a once-weekly subcutaneous injection. PE0139 is a fully mature, native insulin molecule genetically fused to PhaseBio’s elastin-like polypeptide biopolymer. A Phase 1 single ascending dose study of PE0139 in adults with type 2 diabetes demonstrated prolonged exposure to the drug that would enable once-weekly administration and a low peak-to-trough ratio. In nonclinical models of diabetes, PE0139 has demonstrated a flat PK curve with a long elimination phase and a reduction in blood glucose of significantly greater duration than with insulin glargine. In additional nonclinical studies, PE0139 demonstrated a strong synergistic action with PhaseBio’s weekly GLP-1 receptor agonist PB1023.
PhaseBio Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel drugs to treat metabolic and specialty cardiopulmonary disorders. The Company’s proprietary technology platform uses recombinant elastin-like polypeptide (ELP) biopolymers to control the half-life, bioavailability and physical characteristics of molecules for ease of administration. The resulting compounds are engineered for a specific rate of absorption to enhance efficacy and reduce side effects. PhaseBio’s lead development candidates include: PE0139, a novel, super-long-acting basal insulin-ELP fusion for once-weekly dosing; and PB1046, a weekly vasoactive intestinal peptide receptor agonist for the treatment of acute and chronic heart failure, the treatment and prevention of cardiomyopathy associated with Duchenne muscular dystrophy, Becker muscular dystrophy and X-linked dilated cardiomyopathy, and other indications. PhaseBio is privately owned, with headquarters and research laboratories in Malvern, PA.
Laura Bagby, 6 Degrees