Clarametyx Biosciences has received approval from the Independent Data Monitoring Committee (DMC) to progress its Phase Ib/IIa trial of CMTX-101, an immune-enabling antibody therapy aimed at treating cystic fibrosis (CF)-related pulmonary infections.
The randomised, placebo-controlled, double-blind trial is evaluating CMTX-101 as an adjunctive therapy to standard of care antibiotics in CF individuals.
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It focuses on assessing the therapy’s tolerability, safety, immunogenicity, pharmacokinetics, and its ability to decrease pulmonary Pseudomonas aeruginosa burden, among other exploratory endpoints.
According to the company, an interim analysis of the first 21 subjects indicated that the pre-specified criteria to proceed with the study at both five and 30 mg/kg dose levels were met.
CMTX-101-treated subjects showed a decrease in Pseudomonas aeruginosa burden, meeting the prespecified statistical criteria, and the therapy was detected in the sputum of all those treated.
Notably, the therapy was found to be well-tolerated, mirroring the outcomes of a previous trial, without antidrug antibodies identified.
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By GlobalDataThe trial’s next portion will proceed with the assessment of the therapy’s both doses against a placebo in around 20 additional subjects across 23 trial sites.
This includes substantial support from the Cystic Fibrosis Therapeutics Development Network, with full enrolment anticipated to complete by the end of this year.
Clarametyx CEO David Richards said: “We are pleased that the findings from the first 21 participants enrolled support progressing the study without modification.
“The full dataset, which will include exploratory endpoints such as respiratory function, inflammatory biomarkers, and quality of life assessments, will help us further understand the full potential of CMTX-101 as a novel therapeutic solution to a variety of chronic respiratory conditions.”
Clarametyx noted that CMTX-101 is also being developed for CF-associated infections, with potential expansion to other chronic respiratory conditions such as chronic obstructive pulmonary disease, nontuberculous mycobacterial lung disease, and non-CF bronchiectasis.
