Insmed Announces Results of IPLEX(TM) Phase II Trial in Myotonic Muscular...( - Insmed to Evaluate Potential Initia...)

- Insmed to Evaluate Potential Initiation of Phase II Trial for IPLEX(TM) in MMD Patients with Severe Insulin Resistance -

RICHMOND, Va., June 25 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a biopharmaceutical company, today announced results from its exploratory U.S. Phase II clinical trial evaluating IPLEX(TM) (mecasermin rinfabate) in patients with myotonic muscular dystrophy ("MMD"). The randomized, double-blind, placebo-controlled Phase II trial conducted in 13 centers across the U.S. enrolled 69 patients with MMD, for a six-month period. As this was an exploratory trial, a primary endpoint was not pre-defined. The trial explored measures of endurance, using the six-minute walk test, muscle function and strength, cognitive function, gastrointestinal function, pain, quality of life, insulin sensitivity, lipid metabolism, and safety and tolerability of IPLEX(TM).

The results of the trial indicated that IPLEX(TM) did not exhibit a statistically significant improvement in the functional measure of endurance by the six-minute walk test, muscle function, muscle strength, or quality of life in any of the tests utilized in this study. Based on the limited number of subjects enrolled with significant impairments in cognitive function, gastrointestinal function or pain, Insmed was unable to reach any conclusions regarding the effects of IPLEX(TM) on these endpoints.

IPLEX(TM) did, however, demonstrate improvements in standard measures of insulin sensitivity and reductions in fasting glucose, fasting insulin, cholesterol and triglycerides, which is consistent with the expected metabolic profile of insulin-like growth factor. Administration of IPLEX(TM) also resulted in anabolic effects of increased body mass index and higher levels of testosterone. The drug was well tolerated in MMD subjects and d
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