image credit: Pixabay

More trouble for Astellas as AT132 gene therapy trial is halted again

September 1, 2021

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).

Read More on Pharmaphorum