The FDA has placed a clinical hold on Homology Medicines Inc's (NASDAQ:FIXX) pheNIX gene therapy trial of HMI-102 from the FDA. An official clinical hold letter is expected within 30 days.
- The reason for the clinical hold is the observations of elevated liver function tests. Thus, there is a need to modify risk mitigation measures in the study.
- FIXX will provide further updates about the trial after the FDA provides more details and clarity to the Company.
- Also Read: Oxford Biomedica, Homology Medicines Enter Deal To Expand Viral Vector Offerings.
- "This hold on our PKU gene therapy trial is based on clinical observations in the pheNIX study and does not relate to CMC/manufacturing capabilities or Homology's other clinical programs. We plan to provide the next steps once we have more information following our FDA interactions," said Arthur Tzianabos, President & CEO.
- Homology has two ongoing clinical programs, the pheEDIT gene-editing trial of HMI-103 for PKU and the juMPStart gene therapy trial of HMI-203 for Hunter syndrome, with program updates expected by the end of 2022.
- Price Action: FIXX closed 37.3% lower at $2.42 during premarket trading on Tuesday.
