4D Molecular receives RPDD from FDA for aerosolized 4D-710

4D Molecular Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted Rare Pediatric Disease Designation, RPDD, for the Company’s product candidate aerosolized 4D-710 for treatment of cystic fibrosis lung disease. 4D-710 is being evaluated in the Phase 1/2 AEROW clinical trial in people with CF who are not eligible for, or cannot tolerate any of, the currently approved CFTR modulators. “The Rare Pediatric Disease Designation is a very important regulatory milestone in our development path for 4D-710 and highlights the urgent need for novel therapeutic options for people living with CF lung disease, including children, especially those who are not eligible for currently available disease modifying therapies,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “Based on the CFTR expression levels and clinical activity seen to-date, we are excited about the potential for 4D-710 to transform the lives of people with CF with an effective and durable treatment option. We continue to enroll our AEROW clinical trial and work with the CF Foundation and regulators to identify the most efficient path to advance this therapy, with preliminary feedback expected this quarter.”