Dyne Therapeutics to Host Virtual Investor Event to Review New Clinical Data from the ACHIEVE and DELIVER Trials Tomorrow, May 20 at 8:00 a.m. ET

Core Viewpoint - Dyne Therapeutics is set to report new efficacy and safety data from its Phase 1/2 ACHIEVE and DELIVER clinical trials on May 20, 2024, indicating an update to its previous guidance for the second half of 2024 [1] Group 1: Clinical Trials Overview - The ACHIEVE trial evaluates DYNE-101 in adult patients with myotonic dystrophy type 1 (DM1), designed as a registrational trial with a 24-week multiple ascending dose (MAD) period, a 24-week open-label extension (OLE), and a 96-week long-term extension (LTE) [6] - Enrollment for the ACHIEVE trial is complete with 56 patients and approximately 500 doses administered, focusing on various dosing cohorts [6] - The DELIVER trial assesses DYNE-251 in males with Duchenne muscular dystrophy (DMD), also structured as a registrational trial with similar phases as ACHIEVE, and has enrolled 48 patients with approximately 480 doses administered [6] Group 2: Upcoming Data Release - Dyne plans to report safety and tolerability data from all enrolled cohorts in both trials, along with pharmacokinetic and pharmacodynamic data [6] - Efficacy data will be shared from specific dosing cohorts in the ACHIEVE trial, including results from the 1.8 mg/kg Q4W cohort (n=16) at 12 months, 3.4 mg/kg Q4W cohort (n=16) at 6 months, and 5.4 mg/kg Q8W cohort (n=8) at 3 months [6] - For the DELIVER trial, data on dystrophin expression will be reported from the 10 mg/kg Q4W cohort (n=8) at 6 months [6] Group 3: Company Background - Dyne Therapeutics focuses on developing innovative therapeutics for genetically driven muscle diseases using its proprietary FORCE™ platform [5] - The company has a broad pipeline targeting serious muscle diseases, including clinical programs for DM1 and DMD, as well as a preclinical program for facioscapulohumeral muscular dystrophy (FSHD) [5]