Clarametyx Biosciences Announces Positive Topline Data From Phase 2a Study Evaluating CMTX-101 in Cystic Fibrosis

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COLUMBUS, Ohio--(BUSINESS WIRE)--Jan 9, 2026--

Clarametyx Biosciences, Inc. (“Clarametyx”), a clinical-stage biotechnology company developing immune-enabling therapies and vaccines to address biofilm-driven chronic respiratory diseases, today announced positive topline data from a Phase 1b/2a clinical trial evaluating its novel immune-enabling antibody therapy, CMTX-101, in the treatment of people with cystic fibrosis (pwCF). These findings support further development of CMTX-101 in a Phase 2 bronchiectasis trial.

The randomized, double-blind, placebo-controlled Phase 1b/2a clinical study met its primary endpoint demonstrating the safety and tolerability of a single intravenous dose of CMTX-101 in 42 pwCF chronically infected with Pseudomonas aeruginosa receiving standard of care (SOC), including stable regimens of highly effective CFTR modulators and inhaled antibiotics. Treatment with CMTX-101 (5 mg/kg) resulted in a clinically meaningful reduction of neutrophil elastase (77% reduction at day 28 compared to SOC) and reductions in additional inflammatory biomarkers including IL-1 beta, IL-8 and calprotectin. CMTX-101 treatment also demonstrated preservation of pulmonary function measured by FEV1 (forced expiratory volume) from baseline compared to SOC. CMTX-101-treated participants also demonstrated reductions in Pseudomonas aeruginosa burden, with 13/17 subjects achieving greater than 70% reduction in CFU (colony forming unit) count on Day 28 (5 mg/kg). CMTX-101 was generally well tolerated in the study, and no neutralizing antibodies were detected. Comprehensive data analyses from the study ( NCT06159725 ) will be presented at an upcoming scientific conference.

“These highly encouraging results support the potential for CMTX-101 to play a significant role in the treatment of CF and other chronic biofilm-driven respiratory diseases,” said Jerry Nick, MD, Professor of Medicine in the Division of Pulmonary, Critical Care and Sleep Medicine at National Jewish Health, and primary investigator of the study. “This well-conducted, early-stage trial demonstrated meaningful and sustained improvements in inflammatory biomarkers, pulmonary function, and microbiological burden, illustrating its promise to address persistent unmet needs of the CF population, even in the era of highly effective CFTR modulators.”

“The strong results of this 2a study not only demonstrate safety and tolerability of CMTX-101, but also show clinically meaningful measures of efficacy, including preservation of pulmonary function and reduction in key inflammatory biomarker levels, including neutrophil elastase, a biomarker strongly linked to pulmonary exacerbations, airway inflammation and disease progression,” said David V. Richards, Chief Executive Officer of Clarametyx. “These encouraging findings support exploring future development of CMTX-101 in bronchiectasis. We are deeply grateful to the patients and their families, as well as the investigators and clinical site teams, whose participation and tireless efforts were essential to the successful completion of this study.”

The Company plans to engage with global regulatory authorities in the first half of this year to pursue a Phase 2 study evaluating CMTX-101 in bronchiectasis, a chronic respiratory condition with a single approved agent and similar disease physiology to CF.

About CMTX-101

CMTX-101 is an investigational, immune-enabling antibody therapy in development to reduce the burden of chronic respiratory disease. The therapy is designed to precisely and rapidly destroy the universal underlying structure of bacterial biofilms to undermine extracellular bacterial defenses and enable greater response from immune effectors or antibiotics - an approach that can be employed to treat a range of conditions. The goal of treatment is to effectively relieve disease exacerbation and improve patient outcomes by removing biofilms and resolving associated inflammation. In addition to the positive Phase 2 study in cystic fibrosis (CF), CMTX-101 has potential applications in a range of other respiratory conditions associated with inflammation and progressive lung damage, including nontuberculous mycobacterial (NTM) lung disease, non-CF bronchiectasis (NCFB), 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 bacterial biofilms. The Columbus, Ohio-based company is building a pipeline of immune-enabling therapies and vaccines, including CMTX-101, which completed a positive Phase 2 study in cystic fibrosis patients in early 2026, and plans to pursue additional mid-stage studies in other chronic respiratory diseases including bronchiectasis. The company’s second program, CMTX-301, is in early development to evaluate the technology in a preventive approach. For more information, visit us on the web or on LinkedIn.

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KEYWORD: OHIO UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: MANAGED CARE PHARMACEUTICAL HEALTH CLINICAL TRIALS

SOURCE: Clarametyx Biosciences, Inc.

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PUB: 01/09/2026 07:00 AM/DISC: 01/09/2026 07:00 AM

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