Insmed Presents Result Of Phase-II IPLEX Trial

Published: 25-Jun-2009

Trial was intended to treat patients with Myotonic Muscular Dystrophy

Insmed has declared the results of phase-II clinical trial evaluating IPLEX (mecasermin rinfabate) in patients with myotonic muscular dystrophy (MMD).

The randomized, double-blind, placebo-controlled trial conducted in 13 centers across the US, enrolled 69 patients with MMD for a six-month period.

The results of the trial indicated that IPLEX did not exhibit a statistically significant improvement in the functional measure of endurance, by the six-minute walk test, muscle function, muscle strength 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 on these endpoints.

However, IPLEX demonstrated 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.

Melvin Sharoky, Chairman, Insmed, said: We are disappointed that this trial did not meet the majority of its functional endpoints. However, the statistically significant improvement in insulin sensitivity seen in this study suggests that an additional phase II study in MMD patients with severe insulin resistance may be warranted. We appreciate the MDA's financial support for the completed trial and look forward to the possibility of continuing to work with them.

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