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Audentes Set To Resume XLMTM Trial As US Hold Lifts

Talks With Regulators On Way Forward

 
• By Ian Haydock

Trial of high-need gene therapy set to restart following the deaths of several participants and the lifting of a clinical hold imposed by the US FDA last year.

myotubular myopathy
• Source: Shutterstock

Astellas Pharma, Inc.’s US genetic medicines subsidiary Audentes Therapeutics, Inc. is taking the clinical and regulatory steps to resume dosing in its US Phase I/II ASPIRO trial with the gene therapy resamirigene bilparvovec (AT132) in X-linked myotubular myopathy (XLMTM), following the formal lifting of a clinical hold.

The US Food and Drug Administration said on 24 December it had lifted its hold on the study originally imposed in late June last year, following

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