BiomX(US:PHGE) Benzingaยท2025-10-17 12:30Core Insights - BiomX has addressed the FDA's queries regarding the third-party nebulizer used for BX004, which were narrow in scope, and has responded to an additional request for technical clarifications [1][2] - The FDA's new feedback highlights the significant unmet need for therapies targeting chronic Pseudomonas aeruginosa infections in cystic fibrosis patients and outlines potential development pathways [5][6] - Patient enrollment and dosing in Europe for the BX004 Phase 2b trial are progressing ahead of schedule, with topline results expected in the first quarter of 2026 [3][4] FDA Interaction - BiomX, in collaboration with the nebulizer manufacturer, provided comprehensive data to address the FDA's initial clinical hold on the U.S. portion of the Phase 2b trial [2] - The FDA has not raised concerns regarding the BX004 drug product itself, focusing solely on the nebulizer device [2] Clinical Trial Progress - The BX004 Phase 2b trial is on track to report topline results in Q1 2026, with all nebulizer components used in the European trial being CE marked and approved for use in the EU [3][4] - BiomX plans to enroll approximately 60 patients in a randomized, double-blind, placebo-controlled Phase 2b trial, assessing lung function, bacterial load, and quality of life metrics [8] Development Strategies - The FDA's feedback recognizes the ongoing unmet need for therapies in cystic fibrosis, suggesting opportunities to refine inclusion criteria and enrich patient populations for a Phase 3 program [5][6] - BiomX intends to incorporate the FDA's recommendations into its development plans and anticipates further discussions at an End-of-Phase 2 meeting after the Phase 2b trial results [6]