Genaera initiates second Phase I study of diabetes drug

This randomized, vehicle-controlled study, being conducted in San Antonio, Texas, is enrolling otherwise healthy overweight and obese type 2 diabetic volunteers to evaluate the safety, tolerability, and pharmacokinetics of ascending single doses of intravenously administered trodusquemine (MSI-1436) in this special population. The ascending single dose protocol will initially enroll approximately 28 subjects at four dose levels (three, six, 10, and 15 mg/m2) and is expected to be completed late in the first half of 2008.

The current study will continue to expand the safety database for MSI-1436 and establish the pharmacokinetics of the drug in a population of type 2 diabetics who are poorly controlled on metformin. The study will also evaluate a range of secondary endpoints including short-term insulin/glucose control indices, glucose tolerance and evaluation of insulin sensitivity.

MSI-1436 is a novel therapeutic for the treatment of type 2 diabetes and obesity which works centrally and peripherally to regulate insulin and leptin receptor signaling through inhibition of its novel target enzyme PTP-1B.

Jack Armstrong, president and CEO of Genaera, said: “We anticipate that this clinical study will provide a first step in demonstrating the safety of MSI-1436 in obese and overweight type 2 diabetics and will help determine an optimal therapeutic dose for this population.”