Elicio Therapeutics, Inc. announced on August 5, 2025, that the Independent Data Monitoring Committee (IDMC) provided a positive recommendation to continue the Phase 2 AMPLIFY-7P study without modifications. This decision followed a pre-specified interim review of unblinded safety and efficacy data for ELI-002 7P in mKRAS-driven pancreatic ductal adenocarcinoma (PDAC).
The IDMC's recommendation confirms the favorable safety profile of ELI-002 7P to date and indicates preliminary signals of efficacy. This is a critical step in the clinical development of the lead candidate, reinforcing confidence in its potential.
Elicio anticipates the final disease-free survival (DFS) analysis for the AMPLIFY-7P study in the fourth quarter of 2025. The company previously aligned with the FDA on key elements of the planned pivotal Phase 3 study design, and upon final DFS analysis, plans to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy.
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