Genaera Reports Positive Data From Phase I Study of Diabetes and Obesity Drug
Posted on: Tuesday, 7 October 2008, 09:00 CDT
Genaera, a biopharmaceutical company, has reported data from its second Phase I clinical trial of trodusquemine, the company's lead drug candidate for the treatment of type 2 diabetes and obesity.
In the study, trodusquemine (MSI-1436) was found to be well-tolerated and no serious adverse events were experienced at likely clinical doses. There were indications of dose-dependent weight loss seen in the obese and overweight type 2 diabetic subjects.
Study MSI-1436C-103 was a double-blind, randomized, placebo-controlled safety and pharmacokinetic (PK) study involving obese or overweight adult male and female diabetic volunteers poorly controlled on metformin. Approximately five subjects in each of four dosing groups received MSI-1436 while two subjects in each dosing group received placebo.
Participants were studied at two research sites to evaluate the safety, tolerability and PK of single intravenous doses of three, six or 10mg/m2 of MSI-1436. The study began with a four day in-house study period with post dosing evaluations conducted on study days seven, 14 and 21.
In addition to the favorable adverse event profile seen in the study, the single-dose PK of MSI-1436 was found to be linear and slightly greater than dose proportional following intravenous dosing.
Michael Gast, executive vice president and chief medical officer of Genaera, said: "We believe these results continue to support the potential of MSI-1436 to provide an exciting, new treatment option for patients afflicted by both diabetes and obesity."
Source: Datamonitor
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