The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) announced that its US discovery JV (Bexel Pharmaceuticals Inc.) that has been working on a novel anti-diabetic molecule (BLX-1002), has successfully completed Phase 1(a) clinical trials (double-blinded placebo controlled) and moved the molecule into Phase 1(b) clinical trials in Europe.
The dose-escalation study proved the safety of the molecule upto 1600 mg as compared to the anticipated human dose levels of 20-40 mg. The study has also shown that the therapeutic index of the molecule is >40 making it a highly safe diabetic compound. No hypoglycemic effect was observed in the healthy volunteers. The tests were conducted on 42 healthy volunteers in Europe.
Phase 1(a) clinical trials determine the toxicity and safety levels of the molecule at escalated doses while Phase 1(b) clinical trials are carried out to determine these at repeated dose levels.
"We are confident of moving this molecule into limited Phase 2(a) clinical trials in May 2004. We would like to out-license the molecule after completion of these trials. Towards this, we will initiate negotiations with MNCs at an appropriate time. The molecule was earlier showcased at international conferences like the American Diabetes Association and the International Diabetes Federation Congress where it won critical acclaim and has started generating good enquiries", said K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals Ltd.
BLX-1002 is a novel orally active small molecule with distinct mode of action. In contrast to all known PPAR agonist compounds, BLX-1002 showed no change in liver enzymes and showed decrease in body weight in various pre-clinical studies.