The ASPIRO trial of AT132 has been paused after abnormal liver function tests (LFTs) were seen in a patient receiving the gene therapy, and information on the adverse event has been shared with regulators, according to the drugmaker.
ASPIRO was placed under a clinical hold by the FDA last December after three deaths linked to liver dysfunction were seen in patients treated with a high dose (3.5 x 1014 vg/kg) of the therapy, which was developed by Astellas’ Audentes Therapeutics unit (now renamed Astellas Gene Therapies).
