Clarametyx Biosciences Moves Forward with Phase 2a Study of CMTX-101 for Cystic Fibrosis Infections
Clarametyx Biosciences, Inc. has successfully completed the Phase 1b portion of its clinical trial for CMTX-101, a novel immune-enabling antibody therapy aimed at treating pulmonary infections associated with cystic fibrosis (CF). The company is now initiating the Phase 2a segment to further evaluate CMTX-101 as an adjunct therapy alongside standard care for chronic infections.
“The CF population faces recurrent and chronic lung infections, necessitating new interventions that can enhance bacterial clearance and minimize antibiotic use,” stated Dr. Jerry Nick, Professor in the Division of Pulmonary, Critical Care, and Sleep Medicine at National Jewish Health and the study’s primary investigator. “The preliminary results from the Phase 1b trial show no safety concerns with CMTX-101. If we can clinically confirm its ability to disrupt bacterial defenses and improve antibiotic efficacy, it could represent a significant advancement in treatment strategies for CF patients.”
This upcoming double-blind, randomized, placebo-controlled trial aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and the potential to reduce pulmonary Pseudomonas aeruginosa burden with CMTX-101 in conjunction with standard antibiotic therapies. Following the successful Phase 1b and a favorable safety review from independent committees, the Phase 2a study will enroll up to 41 adults with CF to further evaluate CMTX-101. Initial results from this study are expected to be reported in 2025. More details regarding the trial can be found at ClinicalTrials.gov under the identifier NCT06159725.
The development of CMTX-101 aligns with Clarametyx’s commitment to addressing persistent and challenging infections caused by various bacterial pathogens. The company recently completed an early-stage clinical study of CMTX-101 in patients with community-acquired bacterial pneumonia, yielding important data on safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy. The findings indicated no significant safety issues, minimal anti-drug antibodies, and no neutralizing antibodies. Clarametyx is set to present these positive topline results at IDWeek in Los Angeles on October 18.
“Recurrent infections pose a major challenge for individuals with cystic fibrosis and their families,” said David Richards, Chief Executive Officer. “We believe that a novel approach to enhance the patient’s immune response alongside current antibiotics can alleviate patient burdens, promote better antibiotic stewardship, and potentially mitigate resistance issues. With promising early data from the Phase 1b trial, we are eager to progress to the next phase and showcase the potential of our technology to transform treatment for chronic and persistent infections.
About CMTX-101
CMTX-101 is an immune-enabling antibody therapy 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 technology can be employed to treat a range of bacterial infections, many of which are characterized by the presence of multiple types of bacteria. CMTX-101 is intended to be administered concomitantly with a wide range of standard-of-care antibiotics that target both Gram-negative and Gram-positive bacteria. 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.
About Clarametyx Biosciences
Clarametyx Biosciences is combating the formidable challenge of persistent and recalcitrant 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 for life-threatening bacterial infections associated with biofilms, with a near-term focus on challenging respiratory infections.
