Aspiro Clinical Trial Update : May 6, 2020 : Audentes Therapeutics
“Yesterday morning we learned that a patient in the ASPIRO clinical trial investigating AT132 for X-linked myotubular myopathy (XLMTM) tragically passed away. We extend our deepest sympathies to the family during this time of immeasurable loss and sorrow.
Preliminary findings indicate that the patient passed away as a result of sepsis, and a full investigation is being conducted to determine the extent to which AT132 may have contributed to this event. The company has informed all relevant study investigators and regulatory authorities about this event.
This patient was one of three older patients treated with AT132 at the dose of 3 X 1014 vg/kg in which we have recently observed new serious adverse events. Together with the ASPIRO clinical investigators, we are closely monitoring these patients to understand these adverse events as they continue to evolve.
We will provide relevant updates as appropriate. Patient safety continues to be our highest priority and our commitment to advancing the development of AT132 for XLMTM remains unchanged.”
Audentes Therapeutics
