PhaseBio Pharmaceuticals has started a Phase IIa clinical trial of PE0139, a potential treatment for hyperglycemia associated with diabetes.

PE0139 is a fusion of a fully mature, native insulin molecule with the company’s polypeptide biopolymer.

PhaseBio develops treatments for metabolic and cardiopulmonary disorders.

“PE0139 was well tolerated in a Phase I study, and demonstrated a flat PK profile.”

The trial will evaluate the safety and tolerability of PE0139, as well as the pharmacokinetic (PK) and pharmacodynamic response in adult patients.

Patients tested will have type 2 diabetes mellitus. Up to 50 patients will be given a once-weekly subcutaneous injection of PE0139 for six weeks.

The trial will be multicentre, randomised, and placebo controlled.

PhaseBio chief executive officer Jonathan Mow said: “This Phase IIa 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.

“PE0139 was well tolerated in a Phase I 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.”

In non-clinical models of diabetes, PE0139 caused a longer reduction in blood glucose compared to insulin glargine.

In further non-clinical trials, PE0139 showed a strong synergistic action with PB1023, PhaseBio’s weekly GLP-1 receptor agonist.