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A Phase 1b/2 Open label Study of WVE N531 in Patients with Duchenne Muscular Dystrophy: Part B (FORWARD 53) Study Design and Rationale

A Phase 1b/2 Open label Study of WVE N531 in Patients with Duchenne Muscular Dystrophy: Part B (FORWARD 53) Study Design and Rationale
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United States , United Kingdom , Chelley Casey , Asela Bandara , Eric Smith , Andrew Hart , Laurent Servais , Siddharth Bhatia , Michael Tillinger , Amy Donner , Abu Dhabi , Josepha Haegele , Padma Narayanan , Wave Life Sciences , Alexander Lin Wave Life Sciences , National Clinical Trial , Oxford University Hospitals , Duchenne Muscular Dystrophy , Study Design , Suki Malhi , Sue Saint , Life Sciences , North Star Ambulatory Assessment , Stride Velocity , Phosphoryl Guanidine , Clinical Trial ,

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 and 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,. ....

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Dyne Therapeutics Announces New Clinical Data from ACHIEVE

- 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 - . ....

United States , Amy Reilly , John Cox , Stacy Nartker , Wildon Farwell , Exchange Commission , Dyne Therapeutics Inc , European Medicines Agency , Drug Administration , Myotonic Dystrophy Health Index , Dose Dependent , Mean Splicing Correction Across All Patients , Muscle Strength , Timed Function Tests , Reported Outcomes , Mean Unadjusted , Mean Muscle Adjusted , Dystrophin Expression , Cohort Administered Monthly , Higher Level , Dystrophin Than Reported , Weekly Administered Standard , Functional Improvement , Run Time , Stride Velocity , Safety Profiles ,

SYSNAV Healthcare Announces EMA Primary Endpoint Qualification of Stride Velocity 95th Centile SV95C for Duchenne Muscular Dystrophy

EMA opinion marks the first Qualification of a digital outcome measure for use as a Primary Endpoint in pivotal drug trials
SV95C is an objective, real-world . ....

European Medicines Agency , Primary Endpoint Qualification , Stride Velocity , Duchenne Muscular Dystrophy ,

SYSNAV Healthcare Announces EMA Primary Endpoint Qualification of Stride Velocity 95th Centile (SV95C) for Duchenne Muscular Dystrophy

/PRNewswire/ SYSNAV Healthcare announces that the European Medicines Agency (EMA) considers that for ambulant Duchenne Muscular Dystrophy (DMD) patients. ....

Damien Eggenspieler , European Medicines Agency , Duchenne Muscular Dystrophy , Stride Velocity , Walking Test , Walking Distance , Parent Project Muscular Dystrophy , Sysnav Healthcare ,