Independent Data Monitoring Committee (DMC) has approved continuation of trial as planned with no modifications
Full study enrollment expected by end of 2025
COLUMBUS, Ohio--(BUSINESS WIRE)--Clarametyx Biosciences, Inc. (“Clarametyx”), a clinical-stage biotechnology company developing immune-enabling therapies and vaccines to address biofilm-driven chronic respiratory diseases, announced today that it is advancing a Phase 1b/2a clinical trial evaluating its novel immune-enabling antibody therapy CMTX-101 to treat cystic fibrosis (CF)-associated pulmonary infections, based on the DMC’s approval to proceed following results of a pre-specified interim analysis.
“Interim findings from this study have identified encouraging trends that support the potential benefit of CMTX-101, with no safety issues,” said Jerry Nick, MD, Professor in the Division of Pulmonary, Critical Care and Sleep Medicine at National Jewish Health, and primary investigator of the study. “The next portion of the trial will provide important insights on the potential therapeutic impact of CMTX-101 for the CF population as a novel solution to reduce the burden of chronic infections.”
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 burden 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.
The upcoming portion of the study will continue evaluating both doses of CMTX-101 versus placebo among approximately 20 additional participants from 23 study sites, including significant support from the Cystic Fibrosis Therapeutics Development Network. Study enrollment is expected to be complete by the end of 2025. More information on the study and participating sites is available at ClinicalTrials.gov (http://www.clinicaltrials.gov/) using the identifier NCT06159725.
“We are pleased that the findings from the first 21 participants enrolled support progressing the study without modification. The full dataset, which will include exploratory endpoints such as respiratory function, inflammatory biomarkers and quality of life assessments, will help us further understand the full potential of CMTX-101 as a novel therapeutic solution to a variety of chronic respiratory conditions,” said David V. Richards, Chief Executive Officer, Clarametyx. “We extend our gratitude to the Cystic Fibrosis Therapeutics Development Network, clinical investigators, and the participants and families for their continued participation in this important research.”
About CMTX-101
CMTX-101 is an investigational immune-enabling antibody therapy in development to treat chronic and recalcitrant respiratory infections. The therapy is designed to precisely and rapidly destroy the universal underlying 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 be employed to treat a range of bacterial infections and pathogen types. The goal of treatment is to dramatically improve the effectiveness of antibiotic therapies and innate immune system effectors, improving the time to resolution of the infection and reducing the need for repeated courses of antibiotics. It is currently in development to treat cystic fibrosis-associated infections, with opportunities to expand to other chronic respiratory infections 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, recalcitrant respiratory infections through an innovative technology platform targeting the biofilm—a protective layer around bacteria—to enable a more effective immune response and antibiotic intervention. 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 infections associated with cystic fibrosis, and CMTX-301, which is in early development. For more information, visit us on the web or on LinkedIn.
Contacts
Media Contact:
Kellie Hotz
khotz@clarametyx.com
+1-703-887-6242
