|Audentes Therapeutics Announces FDA Clearance of Investigational New Drug Application for AT132 to Treat X-Linked Myotubular Myopathy|
In addition to ASPIRO, the clinical development program for AT132 includes RECENSUS, a retrospective medical chart review, for which Audentes recently announced data from an initial analysis of 112 male subjects. This analysis confirmed and expanded upon the understanding of the medical burden of XLMTM on patients, families and the healthcare system. Audentes is also conducting INCEPTUS, a clinical assessment and Phase 1 / 2 run-in study. The primary objectives of INCEPTUS are to characterize the disease course and natural history of children with XLMTM, assess the burden of disease on XLMTM patients and caregivers, identify subjects for potential enrollment in ASPIRO, and serve as a longitudinal baseline and within-patient control for ASPIRO. As of
About AT132 for X-Linked Myotubular Myopathy
About ASPIRO, the Planned Phase 1 / 2 Clinical Study of AT132
About Audentes Therapeutics, Inc.
For more information regarding Audentes, please visit www.audentestx.com.
Forward Looking Statements
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