The placebo-controlled, randomized 24-month study was designed to demonstrate the safety and efficacy of DiaPep277 in newly diagnosed patients with T1D.
The study met primary endpoint defined as the change from baseline in C-peptide levels at the end of the study.
The study also met secondary endpoint showing that a greater proportion of DiaPep277 treated patients maintained good diabetic control compared to the placebo.
Initial safety data also demonstrate that DiaPep277(R) was well tolerated.
Study Scientific Steering Committee chairman and Hadassah University Hospital Department of Medicine Diabetes Unit head Itamar Raz said preservation of the endogenous insulin secretion, which was corroborated by the clinical outcome of improved control of Hb1Ac, may fulfill the current vast unmet medical need in this field.
The company claims that additional analyses of clinical, efficacy and safety data from this study are ongoing.