Business
Dyne Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Business Highlights
- Data Anticipated in the Second Half of 2023 from ACHIEVE Clinical Trial of DYNE-101 in DM1 and DELIVER Clinical Trial of DYNE-251 in DMD - WALTHAM, Mass.,
About this update from Dyne Therapeutics, Inc.
[{"type":"text","content":"- Data Anticipated in the Second Half of 2023 from ACHIEVE Clinical Trial of DYNE-101 in DM1 and DELIVER Clinical Trial of DYNE-251 in DMD - WALTHAM, Mass., March 02, 2023 (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 fourth quarter and full year 2022 and business highlights. “2022 was a momentous year for Dyne and our commitment to the rare muscle disease community as we advanced not one, but two programs from our FORCE™ platform into clinical trials. This exciting transition into a clinical-stage company required important work across the organization to engage with individuals and families living with DM1 and DMD, clinicians treating these diseases, regulators and other stakeholders,” said Joshua Brumm, president and chief executive officer of Dyne. “We remain focused on driving to meaningful clinical data readouts for our ACHIEVE and DELIVER trials anticipated in the second half of 2023, including evaluating key biomarkers of dystrophin in DMD and splicing in DM1. With cash runway expected through 2024 and strong fundamentals across the business, we believe we are well positioned to achieve our near-term milestones and to advance our mission of delivering life-transforming therapies for people with serious muscle diseases.” Business Highlights Enrollment continues in ACHIEVE, a Phase 1/2 global clinical trial evaluating DYNE-101 in adult patients with myotonic dystrophy type 1 (DM1). ACHIEVE, which is designed to be a registrational trial, consists 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 primary endpoints are safety and tolerability, with secondary endpoints of pharmacokinetics and pharmacodynamics, including change from baseline in splicing, as well as measures of muscle strength and function. Enrollment continues in DELIVER, a Phase 1/2 global clinical trial evaluating DYNE-251 in males with Duchenne muscular dystrophy (DMD) who have mutations amenable to exon 51 skipping therapy. DELIVER, which is designed to be a registrational trial, consists of a 24-week MAD randomized, placebo-controlled period, a 24-we...