Back To: Home

CLICK HERE FOR WHAT'S NEW IN:
 




 

DMD trial on hold following patient hospitalization
April 2018
SHARING OPTIONS:

CAMBRIDGE, Mass.—In mid-March, Solid Biosciences Inc. was notified by the FDA that its IGNITE DMD trial had been placed on clinical hold. The Phase 1/2 trial is assessing SGT-001 microdystrophin gene transfer in Duchenne muscular dystrophy, investigating the safety and efficacy of SGT-001 in ambulatory and non-ambulatory children and adolescents with DMD. Several days after the first patient was dosed, the patient was hospitalized with a decreased platelet count, a reduction in red blood cell count and evidence of complement activation. Solid Biosciences classified the event as a Suspected Unexpected Serious Adverse Reaction and reported it to the FDA, which placed the trial on hold. Enrollment and dosing is suspended for the time being, and Solid Biosciences is expecting a formal clinical hold letter from the FDA to determine the requirements for resuming the trial.

Back



PAGE UTILITIES


CONTACT US
DDNEWS
Published by Old River Publications LLC
19035 Old Detroit Road
Rocky River, OH USA 44116
Ph: 440-331-6600  |  Fax: 440-331-7563
 
© Copyright 2018 Old River Publications LLC. All righs reserved.  |  Web site managed and designed by OffWhite.