Clarametyx Biosciences Announces Completion of Enrollment in Phase 2a Study of CMTX-101 in Cystic Fibrosis

Audio By Carbonatix

COLUMBUS, Ohio--(BUSINESS WIRE)--Oct 16, 2025--

Clarametyx Biosciences, Inc. (“Clarametyx”), a clinical-stage biotechnology company developing immune-enabling therapies and vaccines to address biofilm-driven chronic respiratory disease, announced today that it has completed enrollment in its Phase 1b/2a clinical trial evaluating CMTX-101, a novel immune-enabling antibody therapy in development to treat cystic fibrosis (CF)-associated pulmonary biofilm infections. Clarametyx expects to report topline data from the study during the first quarter of 2026.

“The speed of study enrollment since we announced the positive interim analysis in June has exceeded our expectations, reflecting high levels of investigator and patient interest in a novel therapeutic for managing chronic respiratory disease,” said David V. Richards, Chief Executive Officer, Clarametyx. “We look forward to sharing topline results in early 2026, which, if positive, will propel us to the next stage of development in multiple chronic respiratory indications and further unlock the potential of CMTX-101.”

The ongoing randomized, double-blind, placebo-controlled clinical trial is assessing CMTX-101 on top of standard of care therapy 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, released in June, met the pre-specified criteria to continue the trial at both 5 and 30 mg/kg dose levels. Participants in the study demonstrated a reduction in P. aeruginosa burden based on prespecified statistical criteria and CMTX-101 was shown to be present in the sputum of all treated participants. CMTX-101 was generally well tolerated, consistent with the findings reported in a prior clinical study, and no antidrug antibodies were detected. More information on the study and participating sites is available at ClinicalTrials.gov ( http://www.clinicaltrials.gov/ ) using the identifier NCT06159725.

About CMTX-101

CMTX-101 is an investigational, immune-enabling antibody therapy for chronic respiratory diseases. The therapy is designed to rapidly destroy the pro-inflammatory structure of bacterial biofilms to undermine extracellular bacterial defenses and enable more effective immune and antibiotic intervention. Because the target is universally present across bacterial biofilms, the approach can be employed to treat a wide range of biofilm-driven respiratory infections, with the goal of dramatically reducing inflammation and preventing progressive lung function decline. CMTX-101 is currently in a Phase 2 study in cystic fibrosis, with opportunities to expand to other chronic respiratory diseases including nontuberculous mycobacterial (NTM) lung disease, non-CF bronchiectasis, and chronic obstructive pulmonary disease (COPD).

About Clarametyx Biosciences

Clarametyx Biosciences is combating the formidable challenge of chronic respiratory diseases through an innovative technology platform targeting the biofilm—a protective layer around bacteria that drives inflammation and disease exacerbation. The Columbus, Ohio-based company is building a pipeline of immune-enabling therapies and vaccines, including CMTX-101, which is in a Phase 2 study for cystic fibrosis-related, biofilm-driven infections, and CMTX-301, which is in preclinical development. For more information, visit us on the web or on LinkedIn.

View source version on businesswire.com:https://www.businesswire.com/news/home/20251016312767/en/

CONTACT: Media Contact:Kellie Hotz

[email protected]

+1-703-887-6242

KEYWORD: OHIO UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: RESEARCH CLINICAL TRIALS HEALTH TECHNOLOGY OTHER HEALTH BIOTECHNOLOGY GENERAL HEALTH PHARMACEUTICAL HEALTH SCIENCE OTHER SCIENCE

SOURCE: Clarametyx Biosciences, Inc.

Copyright Business Wire 2025.

PUB: 10/16/2025 08:00 AM/DISC: 10/16/2025 08:00 AM

http://www.businesswire.com/news/home/20251016312767/en