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FDA Lifts Hold on Audentes’ Trial of X-Linked Myotubular Myopathy Drug A Biospace article

    The U.S. Food and Drug Administration (FDA) has lifted a clinical hold on Audentes Therapeutics’ ASPIRO trial studying the AT132 as a potential treatment for X-linked myotubular myopathy (XLMTM), a rare neuromuscular disease. The agency  placed the hold  on the Astellas company’s trial after two patients died in the trial. “We are grateful for the efforts of our team and investigators who have worked tirelessly to answer the FDA’s questions and we now look forward to resuming this study,” according to a  statement  made by Natalie Holles, the President and Chief Executive Officer of Audentes Therapeutics. “We want to again extend our deepest sympathies to patients’ families impacted by the events earlier this year. We are deeply committed to the continued safe development of AT132 for the families and patients living with XLMTM, a disease with no existing treatments.” XLMTM, a life-threatening neuromuscular disease, includes hallmark symptoms such as muscle weakness, respiratory fa