Genaera initiates dosing in Phase Ib study of diabetes and obesity drug

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.

Study 102 is a double-blind, randomized, placebo-controlled, safety and PK study being conducted at two US sites. The study will initially enroll 21 subjects at three dose levels (three, six, and 10mg/m2) of MSI-1436 with treatment occurring every three days over a 23 day period.

Approximately 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 II clinical trials in the second half of 2009.

Jack Armstrong, president and CEO of Genaera, said: 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. We expect the multiple dose data from study 102 to verify the exciting potential and positive efficacy results of this drug.