Andromeda reports success in juvenile diabetes Phase III trial

The trial met its primary and secondary endpoints, and was found to be effective and safe.

Andromeda Biotech Ltd. today reported success in the Phase III clinical trial of its Diapep277 drug for the treatment of Type 1 (juvenile) diabetes. The trial met its primary and secondary endpoints, and was found to be effective and safe.The primary endpoint was insulin excretion by the pancreas as measured by C-peptide level. Patients receiving the drug for at least a year showed better excretion of the peptide compared with the control group. In the secondary endpoint, a balanced blood sugar level, patients treated with the drug showed a statistically significant improvement compared with the control group. Diapep277 was also found to be safe, with no significant side effects.

The trial included 457 patients aged 16-45 at 40 medical centers in Israel, Europe, and South Africa. One group received an intravenous injection of Diapep277 every three months over two years; the control group received a placebo. All the patients received insulin depending on their blood glucose levels.

Andromeda is continuing a second Phase III clinical trial with 450 patients at 120 medical centers in Israel, Europe, the US, and South America to verify the results. This trial is due to be completed by mid-2012.

Clal Biotechnology Industries Ltd. (TASE: CBI) owns 84% of Andromeda. In June, Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) exercised its option to invest in the company at a value of $170 million, receiving worldwide marketing rights for Diapep277 in exchange.