Alizyme opens Investigational New Drug Application for U.S. clinical trial of ATL-962
CAMBRIDGE, England, January 31, 2005 -- Alizyme plc has opened an Investigational New Drug (IND) application with the FDA for a clinical trial in the U.S. of ATL-962 in obese subjects.
The trial is a randomised double-blind, parallel-group, repeat-dose pharmacokinetic and pharmacodynamic study. Approximately 80 obese subjects with a Body Mass Index (BMI) of between 30 and 45 will be enrolled, with subjects receiving one of four dose levels of ATL-962 three times daily for 14 days. The study will provide data on faecal fat levels, safety and tolerability in North American obese subjects. Results are expected to be available around the end of 2005.
The opening of an IND for ATL-962 allows Alizyme to discuss the development of the product with FDA in preparation for Phase III studies and ultimately for registration in the U.S. Patient recruitment is also ongoing in Europe for a Phase IIb clinical trial of ATL-962 in obese diabetics. This study in up to 600 patients, which has a Xenical comparator arm in the design, is expected to report results at the end of 2005.
ATL-962, an inhibitor of gastro-intestinal lipases, is designed to cause weight loss by blocking the digestion and thus the absorption of fat from the diet. ATL-962 acts in a similar way to Xenical, the anti-obesity drug marketed by Roche.
Source: Alizyme www.alizyme.com
Posted: January 2005