- The FDA has signed off Aptorum Group Limited's APM IND application to initiate clinical trials of SACT-1 for neuroblastoma.
- The IND-opening trial is a bioavailability/food effect study that will take four months to complete.
- The bioavailability/food effect study aims to compare the relative bioavailability of the newly developed SACT-1 pediatric formulation in healthy adult subjects.
- The above study will follow a planned Phase 1b/2a trial in pediatric patients with relapsed or refractory high-risk neuroblastoma.
- SACT-1 is an orally administered repurposed small molecule drug designed to suppresses MYCN expression (a protein found in neuroblastoma patients).
- SACT-1 is designed to be used especially in combination with standard-of-care chemotherapy.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: APM shares are up 2.66% at $2.70 during the premarket session on the last check Wednesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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