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US FDA lifts clinical hold on Oxford BioMedica partner's trial

ALN

Oxford BioMedica PLC on Tuesday noted that the US Food & Drug Administration lifted the clinical hold on Homology Medicines Inc's pheNIX gene therapy trial.

Homology Medicines owns 20% of Oxford BioMedica Solutions LLC, with Oxford Biomedica holding the majority 80% share. The company is its partner in the US.

The trial is evaluating HMI-102 in adults with phenylketonuria, a rare inherited disorder which prevents the body from breaking down the amino acid phenylalanine. This can then build up in the blood and brain, potentially leading to brain damage.

The trial was halted due to elevated liver function tests. These have since been resolved, the company said, with no hospitalizations required.

Shares in Oxford BioMedica were down 3.8% at 433.77 pence on Tuesday in London.

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