Peptimmune, Inc. a privately held biotechnology company, announced that physicians have treated the first participant in a clinical trial to evaluate the safety, tolerability and pharmacokinetics of GT389-255, a lipase inhibitor conjugated to a fat binding polymer for the treatment of obesity.
The Phase I single ascending dose (SAD) double blind placebo controlled randomized study will involve 48 healthy male volunteers who will receive the drug in six escalating dose cohorts. Later in 2004, the SAD study will be followed by a multiple ascending dose Phase I study (MAD). If Phase I development is successful, Peptimmune anticipates launching a Phase II trial in patients with obesity in 2005.
GT389-255 is a novel conjugate of a pancreatic lipase inhibitor and a fat binding hydrogel polymer. It acts within the gastro-intestinal tract to prevent fat digestion and is expected to have fewer side-effects than currently marketed therapies. The reduction in caloric intake and lowering of fat absorption may lead to weight loss, with potential concomitant improvement in both diabetic and cardiovascular risk profiles. GT389-255 has been evaluated in a number of preclinical studies, including investigational new drug-enabling toxicology studies. Peptimmune licensed GT389-255 from Genzyme Corporation earlier this year.
"The commencement of this clinical trial is an important milestone for the development of GT389-255 and for the company," stated Thomas Mathers, President of Peptimmune. "The goal for GT389-255 is the development of a lipase inhibitor/fat binder that provides inhibition of fat absorption and associated weight loss, but mitigates the gastrointestinal side effects associated with undigested trigylerides in the colon."