PhaseBio Pharmaceuticals, Inc., a biopharmaceutical company focused on therapies based on biopolymers for metabolic and cardiopulmonary conditions, recently announced the start of a Phase 2a clinical trial to assess the company’s new candidate product PE0139, a super-long-acting basal insulin, as a therapy for hyperglycemia (high blood sugar levels) associated with diabetes. The trial is currently recruiting participants with type 2 diabetes.
Type 2 diabetes is the most common form of diabetes affecting 90 to 95% of the individuals diagnosed with the disease. Patients with type 2 diabetes do not make enough insulin or do not use it properly, leading to insulin resistance and eventually to hyperglycemia. Insulin is a hormone essential to control blood sugar levels and convert sugar, starches and other foods into energy.
PhaseBio’s PE0139 is a long-acting native insulin developed for the treatment of hyperglycemia in patients with diabetes that is administered in a once-weekly regimen through a subcutaneous injection. PE0139 is a fully mature native insulin molecule genetically fused to an elastin-like polypeptides (ELP) polymer, a technology developed by PhaseBio that allows the control of the half-life, bioavailability and physical properties of molecules so that a prolonged exposure and once-weekly dosing can be achieved with reduced side effects.
The Phase 2a clinical trial (NCT02581657) now initiated is a randomized, multicenter, double-blind, placebo-controlled study evaluating a multiple sequential ascending dose of PE0139 in terms of tolerability, safety, pharmacodynamic and pharmacokinetic response in adult patients with type 2 diabetes mellitus. The company expects to enroll up to 50 subjects, and the trial will be conducted 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 in a company’s press release. “PE0139 was well tolerated in a Phase 1 study and demonstrated a flat PK [pharmacokinetic] 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.”
To know more about this clinical trial and how you can participate, please visit the following link.