Business
Dyne Therapeutics Reports Second Quarter 2023 Financial Results and Business Highlights
- On Track to Report Initial Data from ACHIEVE Clinical Trial of DYNE-101 in DM1 and DELIVER Clinical Trial of DYNE-251 in DMD During the Second Half of 2023
About this update from Dyne Therapeutics, Inc.
[{"type":"text","content":"- On Track to Report Initial Data from ACHIEVE Clinical Trial of DYNE-101 in DM1 and DELIVER Clinical Trial of DYNE-251 in DMD During the Second Half of 2023 - WALTHAM, Mass., Aug. 03, 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 second quarter of 2023 and business highlights. “This is an exciting time for the entire Dyne team as we continue to enroll and dose patients in our ACHIEVE and DELIVER trials and are on track to report our first clinical data from both during the second half of this year, including evaluating important biomarkers of splicing in DM1 and dystrophin in DMD,” said Joshua Brumm, president and chief executive officer of Dyne. “In addition to progressing our clinical programs, we were also pleased to present preclinical data at ASGCT in May demonstrating the FORCE™ platform achieved TfR1-mediated delivery to the CNS, building on previous work showing delivery to skeletal, smooth and cardiac muscle in multiple well-validated preclinical models. CNS symptoms contribute significantly to the burden of neuromuscular disease, and we look forward to further exploring this application of the FORCE platform. Our commitment to advancing the treatment and care of individuals living with rare muscle diseases continues to drive our efforts with a sense of urgency.” 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. DELIVER, which is designed to be a registrational trial, consists of a 24-week MAD, ra...