Business
Dyne Therapeutics Reports First 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., May 11, 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 first quarter of 2023 and business highlights. “We are making excellent progress in both our ACHIEVE and DELIVER trials and are on track to report initial data from both in the second half of 2023, including evaluating the key disease-driving biomarkers of splicing in DM1 and dystrophin in DMD,” said Joshua Brumm, president and chief executive officer of Dyne. “Additionally, we are pleased to be presenting on our FORCE™ platform and clinical programs at premiere scientific meetings, engaging with the communities treating and living with DM1 and DMD. In particular, we are excited about the preclinical data that are being shared at ASGCT this month which, for the first time, demonstrate that FORCE leveraged TfR1 to deliver to the CNS, reinforcing the potential broad applicability of the platform to address multiple clinical manifestations of neuromuscular 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. DELIVER, which is designed to be a registrational 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 primary endpoints are safety, tolerability and change from baseline in dystrophin ...