Study 102 will establish multiple dose pharmacokinetics (PK) and expand the safety database for MSI-1436 in a population of overweight and obese adult type 2 diabetic subjects who are poorly controlled on metformin. The study will also evaluate key secondary outcomes in this population, including oral glucose tolerance and insulin sensitivity, satiety and weight loss.
"We hope that Study 102 will help establish proof-of-concept for MSI-1436 as a highly competitive treatment for both type 2 diabetes and obesity with a single drug," said
Study 102 is a double-blind, randomized, placebo-controlled, safety and PK study being conducted at two U.S. sites. The study will initially enroll 21 subjects at three dose levels (3, 6, and 10 mg/m2) of MSI-1436 with treatment occurring every three days over a 23 day period. Five subjects in each dosing group will receive MSI-1436 and two subjects in each dosing group will receive placebo. The multiple ascending dose protocol has an adaptive design permitting the enrollment of additional subjects in each cohort. Data from the study is expected in the first half of 2009.
MSI-1436 is also being evaluated in preclinical studies using a once-weekly subcutaneously administered formulation which Genaera expects to utilize in Phase 2 clinical trials in the second half of 2009.
About Trodusquemine (MSI-1436)
Trodusquemine is a centrally and peripherally-acting appetite suppressant and the first highly selective inhibitor of protein tyrosine phosphatase 1B (PTP1B), an enzyme central to controlling the function of both the leptin and insulin pathways. By inhibiting PTP1B, MSI-1436 is expected to decrease appetite and normalize blood sugar. 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.
About Genaera
Genaera Corporation is developing trodusquemine (MSI-1436), for type 2 diabetes and obesity currently in Phase 1 clinical testing and has a fully out-licensed partnership with MedImmune, Inc. that is in Phase 2 clinical testing in asthma. For further information, please see our website at www.genaera.com.
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SOURCE Genaera Corporation