FDA News

Genaera Corporation Initiates Human Study of Obesity Compound Trodusquemine

(May 06, 2007)-- Genaera Corporation announced that it has begun enrolling subjects in the first human clinical study of trodusquemine (MSI-1436) under the Investigational New Drug (IND) application for the obesity compound submitted to the U.S. Food and Drug Administration (FDA) in March 2007. The phase 1 study will enroll healthy overweight and obese volunteers to assess the safety and pharmacokinetics of ascending single doses of trodusquemine. The Company expects to dose the first subjects by the end of May 2007.

Trodusquemine is a centrally and peripherally-acting appetite suppressant and the first highly selective inhibitor of protein tyrosine phosphatase 1B (PTP1B), an enzyme target for the treatment of diabetes and obesity. Trodusquemine has produced consistent, sustainable weight loss in a variety of animal models and appears to overcome metabolic readjustment, which often limits sustained weight loss during caloric restriction. In addition, trodusquemine has shown the ability to reverse co-morbidities associated with obesity such as abnormal glucose metabolism and cholesterol elevation.

“We are pleased that FDA has given Genaera the green light to begin testing trodusquemine in humans and that we were able to efficiently execute our clinical program and proceed into the clinic,” said Jack Armstrong, President and Chief Executive Officer of Genaera. “While the primary endpoint of this first phase 1 study is safety and tolerability, we will be looking for evidence supporting our pre-clinical observations that trodusquemine induces appetite suppression and weight loss while normalizing glucose metabolism and insulin sensitivity.”

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