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FDA Places Clinical Hold On Astellas' Phase 1/2 Trial Of AT845 In Late-Onset Pompe Disease

The U.S. Food and Drug Administration has placed a clinical hold on the FORTIS Phase 1/2 trial following the occurrence of a serious adverse event of peripheral sensory neuropathy in one of the trial participants, Astellas Pharma Inc. (ALPMY,ALPMY) said in a statement.

FORTIS is a clinical trial evaluating AT845, an investigational adeno-associated virus (AAV) gene replacement therapy in adults with Late-Onset Pompe Disease.

Pompe disease is a rare, severe, autosomal recessive metabolic disease characterized by progressive muscular degeneration.

The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects and requires additional information about the recently reported serious adverse event. To date, the serious adverse event has been classified by the site investigator as Grade 1 (mild in severity) and deemed serious due to medical significance.

Astellas noted that it is reviewing potential financial impacts of the matter for the fiscal year ending March 31, 2023.

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