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Release issued 8th January 2001
Alizyme plc has successfully completed the first Phase Ib clinical trial of its obesity drug ATL-962. The trial met its objectives in that it provided evidence of efficacy and that ATL-962 was safe and generally well tolerated when administered in repeat doses.
ATL-962 is an inhibitor of lipase (fat digestive enzyme) designed to cause weight loss by blocking the digestion and thus the absorption of fat in the diet. In the trial, ATL- 962 showed evidence of efficacy, as indicated by increased faecal fat levels (the marker for inhibition of lipase), in all dose groups with an indication of dose-dependence.
The trial was a placebo-controlled, double blind, randomised, parallel group study in 27 healthy male volunteers. The trial was designed to determine the efficacy, safety and tolerability of three dose levels of ATL- 962, each administered three times daily for five days. Each dose was administered to 7 volunteers with a further 6 volunteers receiving placebo. All the volunteers were resident in a Phase I unit and received a controlled diet with a defined fat content.
Further Phase Ib clinical trials of multiple doses of ATL-962 will now be implemented in healthy volunteers to generate additional clinical data, prior to entry into a Phase II weight loss study in obese patients later in the year.
Commenting, Dr Richard Palmer, Chief Executive Officer said: "We are delighted to have achieved this important milestone in the development of ATL-962 by obtaining evidence of efficacy, safety and tolerability with repeat dosing. This product continues to be the only prospective direct competitor in development for Roche's Xenicalâ for a market of significant potential. We can now look forward to its continued progress through development and into Phase II this year."
If you want to find out more about the company visit Alizyme profile.
(17th January 2002) Successful clinical trial completion for Alizyme's Mucostis drug ATL-104
(18th December 2001) Stewart Siddall Resigns Due To Retirement
(17th December 2001) Obesity Drug Completes Phase I Clinincal Trial
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