Oxford Biomedica: FDA Lifts Clinical Hold On Homology Medicines' PheNIX Trial

Oxford Biomedica plc (OXB.L), a gene and cell therapy group, Tuesday noted that the U.S. Food and Drug Administration has lifted clinical hold on Homology Medicines Inc.'s pheNIX gene therapy trial.

Homology Medicines, a genetic medicines company, is the owner of 20 percent stake in Oxford Biomedica Solutions LLC.

The company noted that the FDA has notified Homology that the clinical hold on its pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria or PKU has been lifted.

As Homology previously disclosed, it received official notice of the clinical hold on March 17 and it pertained to elevated liver function tests observed in the trial, which were all resolved with no hospitalizations required.

Homology's response to the FDA included changes to the protocol intended to enhance risk-mitigation measures, including a steroid-sparing immunosuppression regimen.

It was on March 11 that Oxford Biomedica announced that it had completed its deal with Homology to establish Oxford Biomedica Solutions, a new US-based full scope, Adeno-Associated Virus or AAV manufacturing and innovation business.

Oxford Biomedica Solutions offers a unique 'Plug & Play' platform and fully integrated end-to-end capabilities, including from vector design and process development through to clinical trials.

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