BRIEF—FDA lifts clinical hold on Astellas AT132 trial

Japanese drug major Astellas Pharma announced on December 25 that its wholly-owned subsidiary Audentes Therapeutics has been notified by the US Food and Drug Administration that the clinical hold for the ASPIRO clinical trial evaluating AT132 in patients with X-linked myotubular myopathy (XLMTM has been lifted.

XLMTM is a serious, life-threatening neuromuscular disease characterized by extreme muscle weakness, respiratory failure, and early death.

The clinical hold on the trial was imposed in June this year, after a second patient in the ASPIRO clinical trial investigating AT132 (an investigational gene therapy product candidate) has tragically passed away, Audentes Therapeutics revealed at the time.

Audentes, which was acquired by Astellas last December in a $3 billion deal, is now working to complete all clinical and regulatory activities necessary to resume dosing, and plans to have discussions at a future date with the regulators on the path forward toward global registration filing for AT132.