Phase III trial of DiaPep277 meets endpoints in T1D-Andromeda Biotech

Results from a Phase III study (DIA-AID 1) of DiaPep277, from Andromeda Biotech, for treating patients with Type 1 Diabetes, met its primary endpoints and will be published shortly. The results show significant preservation of insulin secreting cells in patients treated with DiaPep277 compared to the placebo arm, treatment effect of 23.4%. The study also demonstrated that a greater proportion of DiaPep277 treated patients maintained good diabetic control compared to the placebo (measured by HbA1c equal or less than 7% at the end of the study), had a lower rate of hypoglycemic events and achieved partial remission.

Safety data indicate that DiaPep277 was well tolerated. No major differences in drug-related adverse events were reported between the treatment and placebo groups. See: "Evaluation of Long-Term Treatment Effect in a Type 1 Diabetes Intervention Trial: Differences after Stimulation with Glucagon or a Mixed-Meal" by Pozzilli et al, and "Treatment of Recent Onset Type 1 Diabetes Patients with DiaPep277: Results of a Double-Blind, Placebo-Controlled, Randomized Phase 3 Trial" by Raz et al. To be published in Diabetes Care, March 2014.