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news.Biopharmaceutical firm Insmed has initiated a 24-week, multi-center, randomized, double blind, placebo-controlled Phase II clinical trial with Iplex in patients with myotonic muscular dystrophy. The decision to initiate this trial is based on the results from an ongoing open-label, dose-escalation trial.
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The purpose of the Phase II study is to confirm the positive results obtained in the ongoing open-label study. The study will include 60 patients and will be powered to detect a 75 meter difference between Iplex and placebo for the change in distance walked during the six minute walk test. The results from this Phase II study will be used to establish the design for Phase III clinical development.
Dr Geoffrey Allan, president and CEO of Insmed, said: “We are very excited by our initial observations with Iplex in the management of this major debilitating condition where there is no effective treatment and we are extremely pleased to announce the initiation of this expanded study. Provided the results of this confirmatory clinical trial replicate those of the ongoing, open-label, dose-escalation study, we believe we will be able to rapidly move Iplex into Phase III development for myotonic muscular dystrophy, an indication which we believe represents a significant market opportunity for the company.”