Elicio Therapeutics, Inc. announced on January 22, 2025, that it received supportive feedback from the U.S. Food and Drug Administration (FDA) regarding the registrational strategy for ELI-002. This feedback came during an End of Phase 1 Type B meeting, providing clarity on the path forward for the lead candidate.
The company achieved alignment with the FDA on key elements of the potential Phase 3 study design. These elements include the dose, dosing schedule, target patient population (KRAS-mutated pancreatic adenocarcinoma), and the primary study endpoint of disease-free survival, based on modified RECIST criteria.
Elicio expects to file a Biologics License Application (BLA) if supported by a planned Phase 3 trial. The ongoing Phase 2 AMPLIFY-7P study is fully enrolled and remains on track for a pre-planned interim data analysis in the first half of 2025, with positive results potentially leading to rapid advancement into a Phase 3 study.
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