Second death in Audentes gene therapy trial may highlight need for more careful dosing

Astellas gained AT132, Audentes’ lead program, via its $3B acquisition of the biotech last year

The report of a second patient death in a trial of an AAV8-based gene therapy from Audentes and Astellas renewed decades-old concerns over the modality’s safety, but the adverse events may reflect a need for more careful dosing rather than a systemic safety issue.

FDA placed a clinical hold on the Phase I/II ASPIRO trial of AT132

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