Posted by Michael Wonder on 04 Aug 2025
Clarametyx Biosciences announces FDA grant of fast track and qualified infectious disease product designations for CMTX-101
4 August 2025 - Clarametyx Biosciences today announced that the US FDA has granted fast track and qualified infectious disease product designations under the Gaining Antibiotic Incentives Now (GAIN) Act for CMTX-101’s use to treat people with cystic fibrosis who are affected by chronic bacterial pulmonary infections.
The company’s on-going Phase 1b/2a clinical trial is evaluating CMTX-101 on top of stable, background standard of care therapy in people with cystic fibrosis evaluating safety and tolerability, pharmacokinetics, immunogenicity, reduction of pulmonary Pseudomonas aeruginosa burden, and additional exploratory endpoints.
