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Santhera to Discontinue Phase 3 SIDEROS Study and Development of Puldysa® in Duchenne Muscular Dystrophy (DMD) and Focus on Vamorolone
Santhera Pharmaceuticals announces the discontinuation of its Phase 3 SIDEROS study with Puldysa® (idebenone) in patients with Duchenne muscular dystrophy (DMD) who are in respiratory decline and receive concomitant glucocorticoid treatment. Data from an interim analysis conducted by the independent Data and Safety Monitoring Board (DSMB) concluded that the study was unlikely to meet its primary endpoint. As a consequence, Santhera will discontinue the study, withdraw the European marketing authorization application and end the global development program for Puldysa.
The Company intends to initiate a restructuring plan for the business with a focus on retaining key functions for bringing DMD drug candidate vamorolone to patients and execute on its other pipeline programs.
Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)The purpose of the study is to assess th...
ReveraGen Announces First Patient Enrollment in International Pivotal Trial of Vamorolone in Duchenne Muscular Dystr...ReveraGen BioPharma, Inc. today announce...
Potential DMD Therapy Vamorolone Shows Positive Effects in Phase 2a Trial, Study ReportsVamorolone, a Duchenne muscular dystroph...
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Phase IIa trial in Duchenne muscular dystrophy shows vamorolone is a first-in-class dissociative steroidal anti-infl...We report a first-in-patient study of va...
Expanded Access Protocol for Boys With Duchenne Muscular DystrophyThe intent of this protocol is to provid...