Dyne DMD Phase 1/2 Trial 'Impact on Key Biomarkers, Improvement in Multiple Functional Endpoints'

 - In Phase 1/2 ACHIEVE Trial, DYNE-101 Demonstrated Dose Dependent 27% Mean Splicing Correction Across All Patients in the 5.4 mg/kg Cohort at 3 Months -

- DYNE-101 Showed Improvement in Myotonia, Muscle Strength, and Timed Function Tests and in DM1-ACTIVc and MDHI Patient Reported Outcomes -

- In Phase 1/2 DELIVER Trial, DYNE-251 Showed 3.2% Mean Unadjusted (7.6% Mean Muscle Adjusted) Dystrophin Expression at 6 Months in 10 mg/kg Cohort Administered Monthly; 10 Times Higher Level of Dystrophin Than Reported for Weekly Administered Standard of Care1-

- DYNE-251 Demonstrated Trends in Functional Improvement in NSAA, Time to Rise from Floor, 10-Meter Walk/Run Time, and Stride Velocity 95th Centile at 6 Months in 10 mg/kg Cohort -

- Favorable Safety Profiles for DYNE-101 and DYNE-251 with Enrollment Complete in the 6.8 mg/kg Cohort of ACHIEVE and 40 mg/kg Cohort of DELIVER -

- Based on Recent Regulatory Interactions, Continuing to Pursue Expedited Approvals for Both Programs with Update on Registrational Pathways Expected by Year-End -

- Virtual Investor Event Today, May 20 at 8:00 a.m. ET -

Virtual Investor Event

Dyne will host a live video webcast event to discuss these ACHIEVE and DELIVER data today, May 20, 2024, at 8:00 a.m. ET. The live webcast will be available on the Events & Presentations page of the Investors & Media section of Dyne’s website and a replay will be accessible for 90 days following the presentation. An accompanying slide presentation will also be available. To access the presentation, register for the live webcast and replay, please visit https://investors.dyne-tx.com/news-and-events/events-and-presentations.

https://www.globenewswire.com/news-release/2024/05/20/2884726/0/en/Dyne-Therapeutics-Announces-New-Clinical-Data-from-ACHIEVE-Trial-of-DYNE-101-in-DM1-and-DELIVER-Trial-of-DYNE-251-in-DMD-Demonstrating-Compelling-Impact-on-Key-Disease-Biomarkers-a.html