BioWorld International Correspondent

LONDON - Alizyme plc announced positive results in a Phase IIb trial of the lipase inhibitor cetilistat in obese diabetics. The results clear the product for Phase III, meaning the company now has three products at that stage.

While cetilistat was as effective as the only other licensed lipase inhibitor, Xenical, in promoting weight loss and reductions in HbA1C, a marker of diabetic control, cetilistat had a better side effect profile.

There were fewer adverse events, and those that occurred were less severe, leading to better patient compliance.

Richard Palmer, CEO, told an analysts' meeting that the "generally inconsequential adverse event profile" in the patients supported "the attractiveness and competitiveness of cetilistat's product profile."

Palmer added that cetilistat now is qualified for Phase III development, and the results will bolster ongoing dialogue with potential partners.

Shares in Cambridge, UK-based Alizyme rose by 8 pence to £1.44 (US$2.55) when the results were announced Monday.

The multicenter European trial enrolled 612 clinically obese patients whose disease was managed with metformin. It was a randomized, double-blind parallel group design comparing three doses of cetilistat with placebo, and with F. Hoffmann-La Roche Ltd.'s Xenical, all taken three times daily. The endpoints were effects on weight loss and markers of diabetes, together with safety and tolerability.

Cetilistat, at the two active doses of 80 mg and 120 mg, caused statistically significant weight loss compared to placebo, and comparable weight loss to 120 mg doses of Xenical, over the 12-week treatment period. It also caused statistically significant reductions in HbA1C that were similar to that seen with other anti-obesity drugs.

Palmer said: "We're delighted with these results, which demonstrate a level of efficacy consistent with that achievable by other weight loss drugs. In addition, the improvement in HbA1C supports the potential utility of additional drug treatment in the management of obese diabetic patients."

Cetilistat is licensed to Takeda Chemical Industries Ltd. in Japan, with Alizyme retaining all other rights. Palmer said preparations for Phase III will continue alongside licensing discussions.