- The FDA has placed a clinical hold on Astellas Pharma Inc's (OTC:ALPMY) FORTIS Phase 1/2 trial following a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants.
- FORTIS trial is evaluating AT845, an investigational adeno-associated virus (AAV) gene replacement therapy in adults with Late-Onset Pompe Disease.
- The FDA has informed Astellas that it did not have sufficient information to assess the risks to subjects and requires additional information about the recently reported SAE.
- To date, the site investigator has classified the SAE as Grade 1 (mild in severity) and deemed serious due to medical significance.
- Astellas is working closely with the site investigator to follow the patient's clinical course and will continue gathering and reviewing all relevant data.
- All enrolled participants will continue to be monitored closely per the study protocol.
- Astellas is reviewing the potential financial impacts of this matter for the fiscal year ending March 31, 2023.
