4DMT Advances 4D-710 to Phase 2 with Additional Funding and Support from the Cystic Fibrosis Foundation

Core Insights - 4D Molecular Therapeutics has received up to $11 million in additional funding from the Cystic Fibrosis Foundation to accelerate the development of 4D-710 for cystic fibrosis lung disease [1][3][5] - The funding includes an initial tranche of $7.5 million and aims to enhance the strategic planning and coordination of 4D-710's development through a newly formed Joint Steering Committee [1][4][5] - The ongoing AEROW clinical trial is assessing the impact of 4D-710 on lung health, with enrollment in Phase 2 currently underway [5][6][8] Funding and Development Support - The CF Foundation's investment will be provided in two tranches, with the second tranche contingent on meeting specific clinical milestones [3][5] - The funding will support the advancement of 4D-710 into Phase 2 and prepare for Phase 3 readiness, including a second dosing expected to occur at least one year after the initial dose [5][6] - A Joint Steering Committee will be established to provide guidance and coordination for the clinical and operational progress of 4D-710 [4][5] Clinical Trial Details - The AEROW clinical trial includes a Phase 1 Redosing Cohort where selected participants will receive a second dose of 2.5E14 vg [6] - The trial has been amended to add additional clinical endpoints, including multiple-breath washout and high-resolution computed tomography to assess lung function and structure [6] - Interim Phase 1 data and program updates are expected to be shared by the end of 2025 [4][5] About Cystic Fibrosis and 4D-710 - Cystic fibrosis is a progressive genetic disease affecting nearly 40,000 people in the U.S. and over 105,000 globally, leading to severe lung function impairment [7] - 4D-710 is designed to be a durable, redosable, and variant-agnostic genetic medicine aimed at improving airway function and quality of life for individuals with cystic fibrosis [8] - The product has received Rare Pediatric Disease Designation and Orphan Drug Designation from the U.S. FDA, highlighting its potential significance in treating CF [8]