Phase 2a of CMTX-101 clinical trial for CF lung infections starts
Treatment aims to boost efficacy of antibiotics in CF lung infections
A clinical trial assessing the safety and tolerability of CMTX-101, an antibody-based therapy for cystic fibrosis (CF) lung infections, has started its second part.
Phase 2a of the Phase 1b/2a trial (NCT06159725) aims to enroll up to 41 adults with CF at several sites in the U.S., treatment developer Clarametrix Biosciences said. Patients will receive the therapy, or a placebo, together with standard-of-care antibiotics. Initial results are expected in 2025.
In the study’s first part, all patients received a single intravenous (into-the-vein) infusion of the treatment, as well as a safety data review and a recommendation from independent committees.
“We are encouraged by the initial data from the 1b portion of the study, which demonstrated no safety signals with CMTX-101,” Jerry Nick, MD, professor at the National Jewish Health Department of Medicine and the study’s primary investigator, said in a company press release. “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 CF.”
Targeting lung infections
CF is caused by mutations in the CFTR gene, resulting in the abnormal accumulation of thick and sticky mucus in the lungs and other organs. Mucus buildup provides an ideal environment for bacteria growth, and patients commonly experience recurrent lung infections, mainly those caused by Pseudomonas aeruginosa, or P. aeruginosa.
Treating these infections typically involves antibiotics. But if these are administered frequently or for long periods, bacteria may develop antibiotic resistance, limiting treatment efficacy.
“The CF 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,” Nick said.
CMTX-101 is an antibody-based therapy that targets and removes linchpin proteins present in bacterial biofilms, protective structures formed by bacteria that stick to each other and to a surface, shielding bacteria from immune and antibiotic attack.
The therapy is expected to destroy the structure of biofilms, making bacteria more susceptible to antibiotics. And because CMTX-101 targets proteins universally present in bacteria, it can be used to treat a wide range of bacterial infections, together with standard antibiotics.
The treatment is expected to improve the efficacy of antibiotics, reducing the time it takes to eliminate an infection and the need of repeated courses of antibiotics.
The ongoing trial is primarily assessing CMTX-10’s safety and tolerability in people with CF who are positive for P. aeruginosa. Secondary outcomes include the treatment’s pharmacological properties and its efficacy in reducing the pulmonary burden of P. aeruginosa.
“[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,” said David Richards, Clarametrix CEO.
Clarametrix recently concluded an early clinical study of CMTX-101 in community-acquired bacterial pneumonia, a type of lung infection. No major safety concerns were found. Top-line data from the study were scheduled to be presented at IDWeek, the joint annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists, being held Oct. 16-19 in Los Angeles.
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