Orchid's US discovery JV successful

Chennai: The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) today announced that its US discovery JV (Bexel Pharmaceuticals Inc.) that has been working on a novel anti-diabetic molecule (BLX-1002), has successfully completed multiple dose Phase 1(b) clinical trials (limited double-blinded placebo controlled) in Europe. The study was conducted at different dose levels of up to 200 mg daily and no adverse impact or reactions were noticed in the healthy volunteers. Clinical laboratory analysis showed no relevant change in liver enzymes such as AST and ALT from the baseline, a key concern with most recently developed anti-diabetic molecules.

Based on these positive and encouraging results and with no change in body-weight and liver enzymes being noticed, the molecule has received an approval from the Independent Ethics Committee (IEC) to proceed with trials on diabetic patients. This study will provide results on the safety and efficacy profile of the molecule in diabetic patients.

Orchid intends to consider out-licensing of the molecule after the Phase 2(a) trials. The molecule is scheduled to be showcased in the 64th American Diabetes Association (ADA) meeting to be held in June 2004.

"The molecule's safety profile has been proved well in healthy volunteers and we anticipate similar results of safety and efficacy in diabetic patients also. Limited proof-of-concept Phase 2(a) trials are expected to be completed by July 2004," said K Raghavendra Rao, Managing Director, Orchid Chemicals & Pharmaceuticals Ltd.

About BLX-1002

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.