Astellas Discontinues Further Screening and Enrollment for ASP0367 (MA-0211) in Pediatric Male Patients with Duchenne

On November 7, 2022, Astellas Pharma shared that they have made the decision to discontinue further screening and enrollment activities for ASP0367 (MA-0211) in pediatric male patients with Duchenne muscular dystrophy.

Please read their full community letter below.


Dear Jett Foundation Community,

Astellas has made the difficult decision to discontinue further screening and enrollment activities for ASP0367 (MA-0211) in Pediatric Male patients with Duchenne Muscular Dystrophy (DMD). This decision was not based on safety concerns, but due to the design of a clinical trial that proved challenging for families to enroll in.

Enrollment of the study 0367-CL-0102 will close immediately and no additional patients will be screened. Currently enrolled patients will continue in trial participation as planned.

Astellas is disappointed about the early enrollment discontinuation of the trial. We are working closely with patient advocacy organizations to provide the Duchenne community an open forum to ask questions and address any outstanding concerns.

On behalf of all of us at Astellas, we would like to express our sincere appreciation for all who have expressed an interest or participated in the study 0367-CL-0102. We look forward to continuing to work with patients and families to improve our overall development strategy and alleviate enrollment hurdles.

If you have any questions, please contact the Astellas team by email (astellas.registration@astellas.com) or phone (800-888-7704). Please reference study 0367-CL-0102 when contacting Astellas. You can also visit Astellas clinical trials for NCT04184882 or visit ClinicalTrials.gov for NCT04184882 to get more information in details.

Sincerely,
Astellas Study Team