Elicio Therapeutics (NASDAQ: ELTX) has announced that the Independent Data Monitoring Committee (IDMC) has recommended that its Phase 2 AMPLIFY-7P study in mutant KRAS (mKRAS)-driven pancreatic ductal adenocarcinoma (PDAC) continue to the final analysis without modifications.
Additionally, the IDMC confirmed the favorable safety profile of ELI-002 7P to date.
In a statement, Robert Connelly, CEO of Elicio, commented, “We are encouraged by the IDMC’s recommendation to support the continuation of the AMPLIFY-7P trial as planned, as we believe it indicates that ELI-002 7P has shown preliminary signals of efficacy. We look forward to the final disease-free survival (DFS) analysis anticipated to occur in the fourth quarter of 2025 and continue to believe that ELI-002 7P has the potential, based on the compelling data generated to date, to offer a new solution to patients facing PDAC in the adjuvant setting.”
He added, “Importantly, we previously reached alignment with the FDA on the key elements of the planned pivotal Phase 3 study design, and, upon final DFS analysis, plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study.”
