Dyne Therapeutics Reports Third Quarter 2022 Financial Results and Business Highlights

About this update from Dyne Therapeutics, Inc.

[{"type":"text","content":"- DYNE-101 ACHIEVE and DYNE-251 DELIVER Clinical Trials Underway with Data Anticipated in the Second Half of 2023 - WALTHAM, Mass., Nov. 03, 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 reported financial results for the third quarter of 2022 and business highlights. “In the third quarter of 2022 we marked incredibly important milestones for Dyne with the initiation of patient clinical trials for our two lead product candidates, DYNE-101 and DYNE-251. Individuals living with DM1 and DMD are in urgent need of new and better therapeutic options. We are inspired by these communities and the clinicians treating them and are grateful for their input and support,” said Joshua Brumm, president and chief executive officer of Dyne. “We are focused on executing on our global trials, ACHIEVE and DELIVER, which are designed to be registrational, and driving towards meaningful clinical data readouts from both anticipated in the second half of 2023.” Business Highlights The ACHIEVE trial evaluating DYNE-101 for the treatment of myotonic dystrophy type 1 (DM1) is underway. It is a Phase 1/2 global clinical trial consisting of a 24-week multiple ascending dose (MAD) randomized, placebo-controlled period, a 24-week open-label extension and a 96-week long-term extension. The ACHIEVE trial, which is designed to be registrational, is expected to enroll approximately 64 adult patients with DM1 who are 18 to 49 years of age. The primary endpoints are safety and tolerability, and the secondary endpoints include pharmacokinetics and pharmacodynamics, including change from baseline in splicing, as well as measures of muscle strength and function. Data from the MAD placebo-controlled portion of the ACHIEVE trial on safety, tolerability and splicing are anticipated in the second half of 2023.The DELIVER trial, a Phase 1/2 global clinical trial evaluating DYNE-251 for the treatment of Duchenne muscular dystrophy (DMD) mutations amenable to exon 51 skipping, is ongoing. The trial consists of a 24-week MAD randomized, placebo-controlled period, a 24-week open-label extension and a 96-week long-term extension. The DELIVER trial, which is designed to be registrational, is expected to...

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