BioWorld International Correspondent

LONDON - Alizyme plc has agreed with the FDA on the Phase III development program for Cetilistat, its lipase inhibitor for obesity and Type II diabetes, enabling the company to intensify partnering discussions ahead of the trials starting in the first half of 2007.

The FDA accepted overall plans for the manufacture and the remaining preclinical development studies, also.

Richard Palmer, CEO, said the scope of the agreement with the FDA provided an efficient and effective pathway to approval. "[This] will aid our discussions with potential partners for Cetilistat."

The Phase III program will require Cambridge, UK-based Alizyme to enroll 4,000 patients in three to four trials, lasting 12 months. In obesity, the primary endpoint is the percentage of those that lose at least 5 percent of body weight, as well as overall weight loss. In Type II diabetes, the endpoint is reduction in levels of the diabetic marker HbA1c.

Further discussions now will take place on the specific details of the protocols. At the same time, Alizyme is talking to European regulators about registration trials for that market.

The company's Japanese partner, Takeda, recently began a Phase II study in Type II diabetes.

Alizyme claims Cetilistat is of equivalent efficiency to all other registered weight-loss drugs, but has a superior side-effect profile. The drug inhibits pancreatic and gastric lipase, preventing fat breakdown and absorption. It has no central nervous system activity.

The plan to start the Phase II trials in 2007 depends on having a partner in place, as Alizyme cannot afford to go it alone. The company last week released financial results for the first half of 2006 showing it had cash of £22.8 million (US$43.1 million) at the end of June, down from £40 million at the same time in 2005.

That money already is spoken for: The company is conducting Phase III trials of two other products and has two Phase II trials in progress, also. The existing commitments mean Alizyme currently has funding until the end of 2007. However, by that time the company will have the results of the two Phase III trials of Renzapride for treating irritable bowel syndrome and COLAL-PRED for treating ulcerative colitis.