Clarametyx Advances Study of CMTX-101 Antibody Therapy for CF-Related Infections, Initiates Phase 2a Trial

Clarametyx is making progress in its study of CMTX-101, an antibody therapy aimed at treating infections in cystic fibrosis (CF) patients. The therapy has shown promise in earlier phases, leading the company to initiate the Phase 2a portion of the clinical trial. This phase aims to further evaluate the therapy's safety and effectiveness in managing CF-related infections.Columbus, Ohio, Saturday, October 19, 2024

Clarametyx Biosciences, Inc., a biotech company specializing in targeted biologic therapies to combat severe biofilm-related infections, announced the completion of the phase 1b portion of its clinical trial for CMTX-101, an immune-enabling antibody therapy aimed at treating cystic fibrosis (CF)-related lung infections, and has now begun the phase 2a portion of the trial.

“Individuals with cystic fibrosis are prone to persistent lung infections, creating a need for treatments that can better facilitate bacterial clearance, reducing reliance on antibiotics,” said Jerry Nick, a professor at the National Jewish Health Department of Medicine and primary investigator of the study. “We are optimistic about the phase 1b results, which showed no safety concerns with CMTX-101. If it is proven to disrupt bacterial defenses and enhance antibiotic and immune response, CMTX-101 could offer a new treatment approach for CF patients.”

This randomized, double-blind, placebo-controlled trial aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and reduction of pulmonary P. aeruginosa load, as well as other exploratory endpoints, for CMTX-101 when used alongside standard antibiotics in CF patients. After completing phase 1b and receiving a safety review committee's approval, the phase 2a study will enroll up to 41 adults with CF to further assess the safety and tolerability of CMTX-101. Initial study results are expected in 2025.

Progress in treating CF-related infections aligns with Clarametyx's goal to address persistent and chronic bacterial infections. The company also recently finished an early-stage trial of CMTX-101 for community-acquired bacterial pneumonia, gathering crucial safety, tolerability, pharmacokinetic, and immunogenicity data, as well as early efficacy insights. The study indicated no major safety concerns, low levels of anti-drug antibodies, and an absence of neutralizing antibodies.

“We understand the challenge that recurrent infections pose for those with cystic fibrosis and their families and believe a novel approach that enhances the immune response and antibiotic efficacy could reduce patient burden and promote better antibiotic stewardship, potentially addressing resistance issues,” said CEO David Richards. “With promising early data from the phase 1b of our CF study, we are eager to move into the next development phase, showcasing our technology’s potential to reshape treatment for chronic infections.”

CMTX-101 is an antibody therapy that targets the core structure of bacterial biofilms, weakening bacterial defenses and enabling more effective antibiotic and immune responses. Its universal bacterial target allows it to address various infections, including those involving multiple bacterial strains. CMTX-101 is designed for use alongside standard antibiotics, targeting both Gram-negative and Gram-positive bacteria, with the aim of improving treatment efficacy, accelerating infection resolution, and reducing the need for repeat antibiotic treatments.

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Source: pharmabiz‍