ARTICLE | Product Development
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
June 30, 2020 12:44 AM UTC
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 in X-linked myotubular myopathy (XLMTM) after the second of three patients who received a high dose of the liver-targeted gene therapy passed away following progressive liver dysfunction...
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