Yesterday, Clarametyx Biosciences announced it had received Fast Track and Qualified Infectious Disease Product (QIDP) designations from the FDA for the company’s investigational antibody therapy, CMTX-101. The therapy is being studied to treat people with cystic fibrosis (CF) who are affected by chronic bacterial pulmonary infections including nontuberculous mycobacterial (NTM) lung disease, non-CF bronchiectasis (NCFB), and chronic obstructive pulmonary disease (COPD).1
“The receipt of both Fast Track and QIDP designations from the FDA underscores CMTX-101's potential as an innovative therapy for patients suffering from chronic respiratory conditions. We look forward to working even closer with FDA to expedite the approval of a new therapy for patients suffering from difficult-to-treat pulmonary conditions,” Clarametyx CEO David V. Richards, said in a statement.” 1
With this news and the company securing funding with its Series A financing from existing investors to support ongoing pipeline activities, Clarametyx is expanding its phase 2 study and aims to have full enrollment by the end of the year.
Study Parameters and Interim Results
The company announced a positive interim analysis in June. The ongoing randomized, double-blind, placebo-controlled clinical trial is assessing CMTX-101 as an adjunctive therapy to standard of care antibiotics in people with CF, evaluating safety and tolerability, pharmacokinetics, immunogenicity, reduction of pulmonary Pseudomonas aeruginosa burden, and additional exploratory endpoints.
An interim analysis of data from the first 21 participants enrolled met the pre-specified criteria to continue the trial at both 5 and 30 mg/kg dose levels. Participants treated with CMTX-101 demonstrated a reduction in P aeruginosa based on prespecified statistical criteria and CMTX-101 was shown to be present in the sputum of all treated participants. Importantly, CMTX-101 was generally well tolerated, consistent with the findings reported in a prior clinical study, and no antidrug antibodies were detected.
Learn more: Clarametyx Biosciences Initiates Phase 2a Trial for CMTX-101 in Cystic Fibrosis Patients
What You Need to Know
Clarametyx’s investigational therapy CMTX-101 received both Fast Track and Qualified Infectious Disease Product (QIDP) designations under the GAIN Act, signaling the FDA’s recognition of its potential to address serious chronic pulmonary infections in conditions like cystic fibrosis, NTM lung disease, NCFB, and COPD.
In a Phase 2a trial, CMTX-101 showed a statistically significant reduction in Pseudomonas aeruginosa burden and was well tolerated with no antidrug antibodies detected, supporting continued evaluation at both tested dose levels.
CMTX-101 works by disrupting bacterial biofilms, a common defense structure among pathogens, enabling better antibiotic and immune response.
About the Agent
CMTX-101 is an investigational immune-enabling antibody therapy in development to address chronic respiratory disease exacerbation and lung function decline. The therapy is designed to precisely and rapidly destroy the universal underlying, pro-inflammatory structure of bacterial biofilms to undermine extracellular bacterial defenses and enable more effective antibiotic and immune intervention. Because the target is universally present across bacteria, the approach can treat a range of bacterial infections and pathogen types.
The goal of treatment is to dramatically improve the effectiveness of innate immune system effectors and antibiotic therapies, thereby addressing inflammation pathways driven by the biofilm state.
References
1. Clarametyx Biosciences Announces FDA Grant of Fast Track and Qualified Infectious Disease Product Designations for CMTX-101. Clarametyx press release. August 4, 2025. Accessed August 5, 2025. https://www.businesswire.com/news/home/20250804750253/en/Clarametyx-Biosciences-Announces-FDA-Grant-of-Fast-Track-and-Qualified-Infectious-Disease-Product-Designations-for-CMTX-101
2. Clarametyx Biosciences Announces Positive Interim Analysis in Phase 2a Study Evaluating CMTX-101 for Infections Associated with Cystic Fibrosis. June 16, 2025. Accessed August 5, 2025.
https://clarametyx.com/positive-interim-analysis-in-phase-2a-study/
