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4DMT Presents Positive Interim Data from Phase 1/2 AEROW Clinical Trial of Aerosolized 4D-710 for Cystic Fibrosis at 2023 NACFC
Aerosolized 4D-710 was generally well tolerated with no inflammation in any lung biopsy across Cohorts 1 and 2 (1E15 & 2E15 vg; n=7) with up to 17 months
About this update from 4d Molecular Therapeutics, Inc.
[{"type":"text","content":"Aerosolized 4D-710 was generally well tolerated with no inflammation in any lung biopsy across Cohorts 1 and 2 (1E15 & 2E15 vg; n=7) with up to 17 months follow-upPromising, reproducible, CFTR expression significantly above normal levels across all participants and all lung tissue samples collected (n=34), substantially exceeding target profileDurable clinical activity demonstrated by improvements in quality of life by CFQ-R-RD and pulmonary function by ppFEV1 through 12 months in Cohort 1FDA feedback on 4D-710 development path as monotherapy and in combination with approved CF modulator therapies expected in Q1 2024Company to host webcast today, Wednesday, November 1, 2023 at 4:30 p.m. ET EMERYVILLE, Calif., Nov. 01, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a genetic medicines company with three novel, highly targeted next generation AAV vectors currently in human clinical studies, today announced interim data from the Phase 1/2 AEROW clinical trial evaluating aerosolized 4D-710 for treatment of cystic fibrosis lung disease. Results will also be presented at the 2023 North American Cystic Fibrosis Conference (NACFC) in both plenary and symposium sessions on November 2-3. “We are pleased with the safety and tolerability of 4D-710 in participants in the AEROW study to date. Participants with cystic fibrosis in this clinical trial do not have the option of treatment with currently available disease modifying therapies and therefore have high unmet need,” said Jennifer L. Taylor-Cousar, M.D., MSCS, Professor, Departments of Medicine and Pediatrics, and Co-Director, Adult Cystic Fibrosis Program, Director, Cystic Fibrosis Foundation Therapeutics Development Center, National Jewish Health and lead Principal Investigator in the AEROW clinical trial, “By delivering copies of the CFTR∆R transgene to the lung epithelium with a novel aerosolized AAV and achieving high levels of CFTR protein expression in airway cells, 4D-710 has the potential to provide durable benefit in these individuals and potentially all individuals affected by CF.” “4D-710, our next generation aerosolized A101 vector, has the potential to address the limitations of prior aerosol gene therapies. Initial results from the AEROW study showed that 4D-710 resulted in CFTR expression in lung airways that significantly exceede...