Pipeline and Publications

Clinical evidence. A clear path forward.

The Clarametyx platform has the potential to generate a robust portfolio of solutions for chronic respiratory diseases. We are initially targeting chronic and recurrent lung diseases impacting ~500,000 adults in the US today, including CF and non-CF bronchiectasis, with opportunities to extend into areas of unmet need such as NTM lung disease and COPD.

The CMTX-101 Platform

CMTX-101 is a first-in-class anti-DNABII monoclonal antibody targeting the upstream driver of chronic respiratory disease. By disrupting bacterial biofilms, CMTX-101 is designed to reduce inflammation and restore immune function to slow lung decline.

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Program

CMTX-101

Indication

Cystic Fibrosis
Phase 2
Phase 3

In a randomized, double-blind, placebo-controlled Phase 1b/2a clinical trial, CMTX-101 met its primary endpoint demonstrating safety and tolerability in 42 people with cystic fibrosis chronically infected with Pseudomonas aeruginosa, on top of standard of care including highly effective CFTR modulators and inhaled antibiotics.

Read more: Completed Phase 1b/2a Study in Cystic Fibrosis

Program

CMTX-101

Indication

Bronchiectasis, Including CF
Phase 2
Phase 3

Building on these results, Clarametyx is advancing CMTX-101 into a Phase 2 bronchiectasis study — the OneBE program — enrolling both CF and non-CF bronchiectasis patients. Phase 2 initiation is planned for 1H27.

The Phase 2 study will evaluate CMTX-101 across a broader bronchiectasis population of approximately 500,000 US adults, with shared pathophysiology to the CF population studied in Phase 1b/2a.

Check back soon for more.

Program

CMTX-101

Indication

Subcutaneous
Preclinical
Phase 1
Phase 2
Phase 3

Clarametyx is developing a subcutaneous formulation of CMTX-101 to expand delivery options and increase the total addressable market. 

A bridging study is planned for 2027.

Publications

Preliminary data support the efficiency and speed of this approach as well as the complementary nature to immune function:

Biofilms can be dispersed by focusing the immune system on a common family of bacterial nucleoid-associated proteins. Mucosal Immunology, 2011.
Evaluation of the kinetics and mechanism of action of anti-integration host factor-mediated disruption of bacterial biofilms. Molecular Microbiology, 2014.
Monoclonal antibodies against DNA-binding tips of DNABII proteins disrupt biofilms in vitro and induce bacterial clearance in vivo. EBioMedicine, the Lancet, 2016.
Redirecting the immune response towards immunoprotective domains of a DNABII protein resolves experimental otitis media. NPJ Vaccines, Nature, 2019.
Immunization with a Biofilm-Disrupting Nontypeable Haemophilus influenzae Vaccine Antigen Did Not Alter the Gut Microbiome in Chinchillas, Unlike Oral Delivery of a Broad-Spectrum Antibiotic Commonly Used for Otitis Media. mSphere, 2020.
Targeting a bacterial DNABII protein with a chimeric peptide immunogen or humanized monoclonal antibody to prevent or treat recalcitrant biofilm-mediated infections. EBioMedicine, 2020.
Nontypeable Haemophilus influenzae newly released (NRel) from biofilms by antibody-mediated dispersal versus antibody-mediated disruption are phenotypically distinct. Biofilm, 2020.
The extracellular innate-immune effector HMGB1 limits pathogenic bacterial biofilm proliferation. Journal of Clinical Investigation, 2021.
Crumbling the Castle: Targeting DNABII Proteins for Collapsing Bacterial Biofilms as a Therapeutic Approach to Treat Disease and Combat Antimicrobial Resistance (Antibiotics). MDPI journals, 2022.
A Humanized Monoclonal Antibody Potentiates Killing by Antibiotics of Diverse Biofilm-Forming Respiratory Tract Pathogens | Antimicrobial Agents and Chemotherapy. ASM Journals, 2022.
Z-form extracellular DNA is a structural component of the bacterial biofilm matrix. Cell, 2021.
Monoclonal antibodies that target extracellular DNABII proteins or the type IV pilus of nontypeable Haemophilus influenzae (NTHI) worked additively to disrupt 2-genera biofilms. Biofilm, 2022.
Disruption of nontuberculous mycobacteria biofilms induces a highly vulnerable to antibiotic killing phenotype. Biofilm, 2023.
Mycobacterium abscessus biofilm cleared from murine lung by monoclonal antibody against bacterial DNABII proteins. Journal of Cystic Fibrosis, 2025.
The natural human adaptive IgG-specific immune response is skewed towards non-protective tail domains of DNABII proteins. Frontiers in Immunology, 2026.
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Clarametyx Expanded Access Policy

Clarametyx Biosciences is a clinical stage biopharmaceutical company committed to developing novel immune-enabling therapies for serious or difficult-to-treat respiratory diseases.

“Expanded access” refers to use of an investigational drug outside of a clinical trial, where the use of the drug is for treatment, rather than gathering data in support of a marketing application.

The main goal of ongoing clinical trials for our investigational agent, CMTX-101, is to gain information about the drug’s safety and efficacy to submit an application to Health Authorities in support of approval to market CMTX-101. For this reason, Clarametyx believes that direct enrollment in a clinical trial is the preferred route of access to a drug, for which we are continuing to develop data on safety, efficacy and tolerability. We believe expanded access outside of a clinical trial may interfere with the conduct of ongoing trials and may disrupt the progress of our development programs, which could potentially delay access to other patients in need.

For this reason, Clarametyx is not making its investigational drugs available on an expanded access basis at the present time. We plan to re-evaluate this policy in the future as additional information becomes available from ongoing clinical trials.

If you have any questions about this policy or would like information about how to participate in our clinical studies, please contact us at info@clarametyx.com. More information on our ongoing clinical trial is available at ClinicalTrials.gov (http://www.clinicaltrials.gov, NCT06159725).

As authorized by the 21st Century Cures Act, Clarametyx may revise this expanded access policy at any time.