Andromeda's type 1 diabetes candidate DiaPep277 meets Ph III primary endpoint

Israel-based Andromeda Biotech, a subsidiary of Clal Biotechnology Industries (TASE: CBI.TA), says initial results from a pivotal Phase III clinical study with its type 1 diabetes drug candidate DiaPep277 show that the study has met its primary endpoint, defined as the change from baseline in C-peptide levels at the end of the study.

Significant preservation of C-peptide levels, a marker for assessing endogenous insulin secretion by pancreatic cells, was demonstrated in patients treated with DiaPep277 compared to the placebo arm. The decline in C-peptide levels was more pronounced in the placebo arm than in the treated group. The difference between the arms reached 0.949 nmol/L/20 minutes, (p=0.0374). This difference reflects a relative preservation of 23.4% compared to placebo. Evaluation of the primary endpoint was performed on patients in the modified ITT population who have at least one measurement post baseline.

…also meets secondary endpoints