CF trial completes enrollment, nears top-line results for lung infections
Interim data suggest treatment reduces bacteria, is well tolerated
Enrollment has finished in a clinical trial testing the experimental therapy CMTX-101, which is designed to help clear out bacterial lung infections in people with cystic fibrosis (CF) and other diseases.
Top-line results from the Phase 1b/2a study (NCT06159725) are expected to be announced in the first quarter of 2026, according to Clarametyx Biosciences, the company developing CMTX-101 and sponsoring the trial.
“We look forward to sharing top-line results in early 2026, which, if positive, will propel us to the next stage of development in multiple chronic respiratory indications and further unlock the potential of CMTX-101,” David V. Richards, CEO of Clarametyx, said in a company press release.
CF is a genetic disease characterized by unusually thick, sticky mucus that builds up in the lungs and other organs. Bacterial lung infections are a common problem for people with CF, and they can be hard to treat in part because infectious bacteria often form biofilms — dense networks of proteins and other molecules that act like a fortress to protect the bacteria. CMTX-101 is designed to destroy biofilms, making it easier for antibiotics and immune cells to eradicate infectious bacteria.
Phase 1b/2a study details and goals
The ongoing clinical trial is testing CMTX-101 in adults with CF infected with Pseudomonas aeruginosa — a specific type of bacteria that often causes problematic lung infections in CF patients. Enrollment finished ahead of schedule. Participants are randomly assigned to receive a single infusion of CMTX-101 at one of three doses, or a placebo, to evaluate safety in the four months following treatment.
Earlier in 2025, Clarametyx reported interim data from the first 21 participants. The preliminary findings showed no safety issues associated with a single infusion of CMTX-101, and data suggested the therapy reduced the amount of P. aeruginosa bacteria in patients’ lungs. According to Clarametyx, the interim data spurred a surge of interest in the trial, allowing it to finish enrollment sooner than expected.
“The speed of study enrollment since we announced the positive interim analysis in June has exceeded our expectations, reflecting high levels of investigator and patient interest in a novel therapeutic for managing chronic respiratory disease,” Richards said.
The U.S. Food and Drug Administration (FDA) recently granted CMTX-101 both fast track designation and qualified infectious disease product designation, intended to speed and incentivize the development of new therapies to fill unmet medical needs.
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