Dyne Therapeutics to Host Virtual Event on ACHIEVE and DELIVER Trials Data Tomorrow, May 20 at 8 a.m. ET

May 19, 2024 – Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company specializing in muscle diseases, has announced a significant update regarding its Phase 1/2 ACHIEVE and DELIVER clinical trials. The company now plans to release new efficacy and safety data on May 20, 2024, and will conduct a virtual event at 8:00 a.m. ET to discuss the findings. This is a modification of their previous schedule, which had anticipated data release in the latter half of 2024. Prior to the event, Dyne Therapeutics will issue a formal press release.

The ACHIEVE trial is a Phase 1/2 global clinical study investigating DYNE-101 in adult patients aged 18 to 49 with myotonic dystrophy type 1 (DM1). The trial is structured to be a registrational study and includes a 24-week multiple ascending dose (MAD), randomized, placebo-controlled period, followed by a 24-week open-label extension (OLE) and a 96-week long-term extension (LTE). Currently, enrollment is completed up to the 6.8 mg/kg cohort, which involves approximately 500 doses administered to 56 patients. During the upcoming clinical update, Dyne will disclose safety and tolerability data from all cohorts. Additionally, they will present pharmacokinetic and pharmacodynamic data, including changes from baseline in splicing, muscle strength and function measurements, and patient-reported outcomes. Efficacy results will be provided from the 1.8 mg/kg Q4W cohort (n=16) at 12 months, the 3.4 mg/kg Q4W cohort (n=16) at 6 months, and the 5.4 mg/kg Q8W cohort (n=8) at 3 months.

The DELIVER trial is also a Phase 1/2 global study, examining DYNE-251 in ambulant and non-ambulant males aged 4 to 16 with Duchenne muscular dystrophy (DMD) who have mutations suitable for exon 51 skipping. This trial, like ACHIEVE, is designed to be registrational and comprises a 24-week MAD, randomized, placebo-controlled period, a 24-week OLE, and a 96-week LTE. Enrollment is complete through the 40 mg/kg cohort, with approximately 480 doses administered to 48 patients. In the imminent clinical update, Dyne will provide safety and tolerability data from all cohorts and share pharmacokinetic and pharmacodynamic data, including dystrophin expression as measured by Western blot, specifically from the 10 mg/kg Q4W cohort (n=8) at 6 months.

The virtual investor event will be accessible via a live webcast available on the Events & Presentations page of the Investors & Media section of Dyne’s website, with a replay available for 90 days post-event. An accompanying slide presentation will also be available. Interested parties can register for the live webcast and replay through Dyne's website.

Dyne Therapeutics is dedicated to developing transformative therapeutics for genetically driven muscle diseases. Utilizing its proprietary FORCE™ platform, the company aims to address delivery challenges to muscle tissue with state-of-the-art oligonucleotide therapeutics. Dyne’s extensive pipeline includes clinical programs for DM1 and DMD, alongside preclinical work on facioscapulohumeral muscular dystrophy (FSHD). Further details are available on Dyne’s website.

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