Homology Medicines: FDA Lifted Clinical Hold on Gene Therapy Trial for PKU

 Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today that the U.S. Food and Drug Administration (FDA) lifted the clinical hold previously placed on the pheNIX gene therapy clinical trial with investigational HMI-102 for adults with phenylketonuria (PKU). The FDA noted in its response that Homology satisfactorily addressed all clinical hold issues identified in its letter of March 17, 2022. Homology plans to share the changes to the protocol, which include a new steroid-sparing immunosuppression regimen that incorporates a T-cell inhibitor and a shorter course of steroids, with the clinical trial sites.

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