Based on the metabolic improvements observed in patients treated with IPLEX(TM) in this trial, and discussions with key opinion leaders, the Company intends to apply for a grant from the Muscular Dystrophy Association ("MDA") to facilitate an additional Phase II trial focused solely on a subset of MMD patients with severe insulin resistance who, based on the results of this trial, may be more likely to benefit from IPLEX(TM) treatment. Alternative methods of assessing muscle function will be considered for the proposed trial.
Dr. Melvin Sharoky, Insmed's Chairman, commented, "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."
Sharon Hesterlee, Senior Vice President and Executive Director of MDA Venture Philanthropy, said, "While the phase II clinical trial of IPLEX(TM) did not show efficacy in the overall MMD population in this trial, based on the data generated, we look forward to evaluating Insmed's grant application for a possible Phase II trial aimed at MMD patients with severe insulin resistance."
Dr. Sharoky continued, "IPLEX(TM) continues to demonstrate a strong safety profile and we believe it offers a potential treatment in multiple therapeutic areas, including Amyotrophic Lateral Sclerosis. Beyond IPLEX(TM), our current cash reserves of approximately $120 million provides us with a significant opportunity to continue growing our business through a variety of potential business development initiatives. We look forward to continuing to exp
|SOURCE Insmed Inc.|
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