Clarametyx Biosciences has announced the advancement of its novel immune-enabling antibody therapy, CMTX-101, into Phase 2a clinical trials for the treatment of cystic fibrosis (CF)-associated pulmonary infections. This follows the completion of the Phase 1b portion of the trial, which demonstrated no significant safety concerns. The study is a double-blind, randomized, placebo-controlled trial designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, and potential reduction of Pseudomonas aeruginosa burden in the lungs of CF patients.
Phase 2a Trial Details
The Phase 2a portion of the trial aims to enroll up to 41 adults diagnosed with CF. Participants will receive CMTX-101 in conjunction with standard-of-care antibiotics. The primary focus of this phase is to further evaluate the safety and tolerability of CMTX-101. Initial findings from the study are anticipated in 2025.
CMTX-101: A Novel Approach to CF Infections
CMTX-101 is designed to target and destroy the universal underlying structure of bacterial biofilms, which are protective matrices formed by bacteria that shield them from both the immune system and antibiotics. By undermining these extracellular bacterial defenses, CMTX-101 aims to enhance the effectiveness of antibiotic therapies and the body's natural immune responses.
According to Jerry Nick, professor at the National Jewish Health Department of Medicine and the study’s primary investigator, "The cystic fibrosis population is vulnerable to recurrent and chronic lung infections, resulting in the need for interventions that can enable more effective clearance of the bacteria to reduce courses of antibiotics." He added, "If clinically confirmed to disrupt bacterial defenses and improve response to antibiotics and natural immunity, CMTX-101 will add a new treatment strategy for people with cystic fibrosis."
Strategic Focus and Prior Studies
The advancement of CMTX-101 in CF-associated infections aligns with Clarametyx’s strategic focus on addressing recalcitrant and chronic infections caused by various bacterial pathogens. The company recently concluded an early-stage clinical study of CMTX-101 in community-acquired bacterial pneumonia, which generated valuable safety, tolerability, pharmacokinetic, and immunogenicity data. This previous study reported no major safety signals, minimal anti-drug antibodies, and no neutralizing antibodies.
Addressing a Critical Unmet Need
Cystic fibrosis is characterized by mutations in the CFTR gene, leading to the accumulation of thick mucus in the lungs and other organs. This mucus creates an environment conducive to bacterial growth, predisposing patients to recurrent lung infections, particularly those caused by Pseudomonas aeruginosa. Frequent or prolonged antibiotic use to treat these infections can lead to antibiotic resistance, highlighting the need for new therapeutic strategies.
"We recognize that recurrent infections are a significant challenge for people living with cystic fibrosis and their families," said David Richards, CEO of Clarametyx. "We believe that a truly novel approach to help the patient’s immune system and today’s antibiotics more effectively clear these infections can not only alleviate the burden on these patients but also support greater antibiotic stewardship and potentially reduce resistance issues."
