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Dyne Therapeutics Announces Clearance of Clinical Trial Application for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1
- Initiation of Dosing in Multiple Ascending Dose Clinical Trial of DYNE-101 in Patients with DM1 On Track for Mid-2022 - - Executing on Global Clinical and
About this update from Dyne Therapeutics, Inc.
[{"type":"text","content":"- Initiation of Dosing in Multiple Ascending Dose Clinical Trial of DYNE-101 in Patients with DM1 On Track for Mid-2022 - - Executing on Global Clinical and Regulatory Strategy: Clinical Trial Application Cleared in New Zealand and Additional Clearances Expected in Multiple Countries - WALTHAM, Mass., July 12, 2022 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that the New Zealand Medicines and Medical Devices Safety Authority cleared its clinical trial application to initiate its Phase 1/2 multiple ascending dose (MAD) clinical trial of DYNE-101 in patients with myotonic dystrophy type 1 (DM1). The Company also anticipates receiving regulatory clearance in additional countries for DYNE-101. Dyne expects to begin dosing patients in its clinical trial of DYNE-101 in mid-2022. “We are pleased to have received our first regulatory clearance for DYNE-101, an important milestone in our efforts to execute our planned global clinical trial for people living with DM1. In addition, we have aligned on the clinical trial design, including our starting dose, with regulatory authorities in multiple countries, and we are focused on initiating the study. Today’s DM1 update, coupled with the recent clearance of DYNE-251 for DMD by the FDA, furthers our commitment to bring our co-lead programs to patients in the clinic in mid-2022,” said Joshua Brumm, president and chief executive officer of Dyne. “We thank the New Zealand Medicines and Medical Devices Safety Authority, FDA and other global regulatory authorities for their partnership as we continue to advance our mission of delivering life-transforming therapies for people with serious muscle diseases.” Dyne plans to evaluate DYNE-101 in a global, randomized, placebo-controlled, MAD clinical trial with a long-term extension study. The trial aims to enroll approximately 60 to 70 adult patients with DM1. The study will evaluate safety, tolerability, splicing index, pharmacokinetics and pharmacodynamics, and measures of muscle strength and function. Dyne plans to outline additional details regarding the trial design and timing of data upon initiation of dosing. About Myotonic Dystrophy Type 1 (DM1) DM1 is a rare, pro...