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4D Molecular Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of 4D-710, an A101 AAV Vector-based, Aerosol-delivered Genetic Medicine for the Treatment of Cystic Fibrosis
EMERYVILLE, Calif., April 04, 2022 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (4DMT) (Nasdaq: FDMT), a clinical-stage biotherapeutics company
About this update from 4d Molecular Therapeutics, Inc.
[{"type":"text","content":"EMERYVILLE, Calif., April 04, 2022 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (4DMT) (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, announced that the first patient has been dosed in its Phase 1/2 clinical trial of 4D-710 in patients with cystic fibrosis. “The dosing of the first patient in the 4D-710 Phase 1/2 clinical trial in cystic fibrosis marks an important milestone for our company and for the patients we aim to benefit,” said Robert Fishman, M.D., Chief Medical Officer and Pulmonology Therapeutic Area Head of 4DMT. “4D-710 utilizes the aerosol-delivered A101 vector developed at 4DMT through our proprietary Therapeutic Vector Evolution platform. To date, our platform has produced five clinical-stage product candidates that incorporate three different proprietary and novel capsids. We are seeking to unlock the full potential of genetic medicines through our platform and to fulfill the promise of transformative biotherapeutics to benefit patients.” “4D-710 is designed for aerosol delivery to achieve CFTR expression within lung airway epithelial cells,” said Jennifer L. Taylor-Cousar, M.D., M.S.C.S, Professor of Medicine and Pediatrics at National Jewish Health and lead principal investigator for the Phase 1/2 clinical trial. “This therapy has the potential to treat a broad range of people with cystic fibrosis independent of their specific CFTR mutations. It could benefit both people with cystic fibrosis who aren’t able to take CFTR modulators as well as those who have a substantial residual deficit in lung function in spite of modulator therapy.” The Phase 1/2 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion trial of 4D-710 in patients (n=~18) with cystic fibrosis who are ineligible for CFTR modulator therapy or who have discontinued therapy due to adverse effects. In the dose-escalation phase, two dose levels of 4D-710 will be examined in a 3+3 design. The primary endpoint of the study is safety and tolerability. Secondary endpoints include assessments of clinical activity including lung function, plus exploratory endpoints on the feasibility of detecting transgene transfer and microCFTR expression as measured in bronchoscopic biopsies and brushings. About 4D-710 and Cystic Fibrosis 4D-710 is compris...