Additional analyses of clinical efficacy and safety data from this study are ongoing. A second confirmatory, global Phase III study with DiaPep277 is currently being conducted at about 120 medical centers in the USA, Canada, Europe, Israel and Argentina. Completion of patient recruitment for this study (450 patients) is anticipated by the first half of 2012.
The 24-month randomized, placebo-controlled study was designed to assess the safety and efficacy of DiaPep277, a novel immunotherapeutic agent for the treatment of newly diagnosed patients with type 1 diabetes (T1D). The results from patients who were treated with 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 (intention-to-treat) population who have at least one measurement post baseline.
The study also achieved a key secondary endpoint, showing that a greater proportion of DiaPep277 treated patients maintained good diabetic control compared to the placebo, measured by HbA1c levels equal to or less than 7% at the end of the study (45.5% versus 35.7%, p =0.035 ). Initial safety data also indicate that DiaPep277 was well tolerated. No major differences in drug-related adverse events were reported between the treatment and placebo groups.