FDA lifts clinical hold on Homology's pheNIX gene therapy trial for HMI-102 in PKU

Q32 Bio Inc.

FDA lifted clinical hold on pheNIX trial (HMI-102) for phenylketonuria; company resolved all issues from March 17, 2022 hold.
Clinical hold related to elevated liver function tests, all resolved without hospitalizations.
Protocol changes include steroid-sparing immunosuppression with tacrolimus and shorter steroid course.
Company plans to provide program update in fall 2022.

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