Israel-based Andromeda Biotech has dosed the first patient with DiaPep277 for the treatment of type 1 diabetes in its extension study to the Phase III clinical trial DIA-AID 2.
The open label, 24-month extension trial is designed to assess long term safety, tolerability, and the effect of DiaPep277 on the ability of patients to maintain glycemic control for two additional years after the completion of the DIA-AID 2 confirmatory study.
The extension study is scheduled to be carried out in medical centres in the US, Europe and Israel, while the DIA-AID 2 is expected to be completed at the end of 2014.
Patients who have completed two years of treatment in the DIA-AID 2 trial and have residual beta cell function regardless whether they were on the actual drug or on the placebo will be eligible to be enrolled in the extension study.
Following enrolment, all eligible patients will be given subcutaneous injections of 1mg of DiaPep277 quarterly for two additional years.
The extension study is part of a clinical development plan that was presented to the regulatory authorities in Europe and in the US. It is expected to be complete at the end of 2016.
Andromeda CEO Shlomo Dagan said: "This is a major step forward in the clinical development pathway for DiaPep277, providing hope to patients who have been facing an unmet clinical need."
DiaPep277 is a peptide of 24 amino acids derived from the sequence of the human heat shock protein 60 (Hsp60) and was invented by professor Irun Cohen and his team at the Weizmann Institute of Science.
The peptide acts by modulating the immune system that prevents the destruction of pancreatic cells that secrete insulin and preserving their natural function.
Medical benefits expected in type 1 diabetes patients, who will be treated with DiaPep277 include slowing the deterioration of the disease, improved metabolic control, reduction of daily insulin dose requirements, and reduction of diabetic complications.