MALVERN, Pa.--(BUSINESS WIRE)--PhaseBio Pharmaceuticals, a clinical-stage biopharmaceutical company focused on diabetes and cardiovascular diseases, today announced that it has initiated the first Phase 1 study for development of PE0139, a novel long-acting basal insulin, for the treatment of Type 2 diabetes.
This single ascending dose, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetic (PK) pharmacodynamic (PD) profile of PE0139 in people living with Type 2 diabetes. The study will also assess the duration of glycemic control ― up to one week ― of the investigational compound. PE0139 is a fully human monomeric insulin fused to an elastin like polypeptide (ELP), PhaseBio’s proprietary biopolymer platform.
“In nonclinical studies, PE0139 demonstrated a smooth, steady-state pharmacokinetic profile with low variability and a longer duration-of-action as compared to other available long-acting insulins,” said Chris Prior, Ph.D., chief executive officer, PhaseBio. “This profile may allow for extended dosing intervals up to once-weekly. We believe that PE0139 represents another opportunity for us to expand our clinical-stage pipeline and demonstrate the significant advantages of our ELP technology platform.”
PE0139 is the result of PhaseBio’s internal research efforts, which discovered that native human insulin could be expressed in E. coli as a correctly refolded monomeric structure when fused to an ELP. The product is formulated in a liquid solution at a relatively neutral pH and retains the potency of commercially available insulins. However, unlike some other insulins, PE0139 demonstrated no binding at the insulin-like growth factor (IGF) receptor in preclinical studies, thereby, potentially reducing the risk of neoplasia which has been associated with the stimulation of IGF.
Coformulation of PE0139 and PB1023 (Once-Weekly GLP-1 Agonist)
The Company has also demonstrated compatibility of PE0139 when co-formulated with PhaseBio’s lead product candidate PB1023, a once-weekly GLP-1 agonist, which may offer development and commercialization opportunities for a combination product. In August 2012, the Company announced the initiation of a multicenter, randomized, placebo and active comparator controlled, 600 patient Phase 2b trial to evaluate the use of PB1023 for the treatment of uncontrolled Type 2 diabetes. Results from this trial are expected in the fall of 2013.
PhaseBio is a clinical-stage biopharmaceutical company developing novel drugs to treat diabetes, metabolic and cardiovascular disease. The Company’s proprietary platform technology uses elastin-like biopolymers (ELPs) to control the half-life, bioavailability and physical characteristics of the molecule for ease of administration. The resulting drug products are tuned for a specific rate of absorption, thereby, potentially increasing efficacy and reducing side effects. The Company’s lead development candidates are PB1023, a once-weekly GLP-1 analogue for type 2 diabetes; PE0139, a novel basal insulin ELP-fusion; and Vasomera, a weekly vasoactive intestinal peptide (VIP) agonist for acute and chronic heart failure and pulmonary arterial hypertension. PhaseBio is privately owned with headquarters and research laboratories in Malvern, Pennsylvania.