Clarametyx Biosciences, Inc has announced the initiation of the Phase 2a trial for its antibody therapy, CMTX-101, following the successful completion of Phase 1b. This new stage will further evaluate CMTX-101 as an adjunct treatment for chronic pulmonary infections in patients with cystic fibrosis (CF).
At IDWeek, David Richards, CEO of Clarametyx Biosciences, highlighted the company’s commitment to tackling bacterial biofilms, which significantly contribute to antibiotic resistance. “Our technology platform is all about bacterial biofilms, which are a key component of bacterial defense that drive recalcitrance and resistance to antibiotic action. Our lead effort is CMTX-101, which is a therapeutic monoclonal antibody. This antibody targets the DNA b2 binding protein, which is a bacterial-only protein that has a critical intracellular function. But for our purposes, it binds an extracellular DNA lattice that stabilizes this bacterial biofilm, and the only thing our drug does is bind that protein, resulting in rapid collapse of the biofilm. This is important because it enables innate immune effectors and antibiotics to do their job better.”
Trial Details:
- Phase 2a Structure: The trial is structured as a double-blind, randomized, placebo-controlled study assessing the safety, tolerability, pharmacokinetics, and immunogenicity of CMTX-101 when used alongside standard antibiotic therapies. The study aims to enroll up to 41 adults diagnosed with CF, with results expected in 2025. Preliminary data from earlier phases indicated no safety concerns associated with the use of CMTX-101.
Richards further detailed the clinical progress, saying, “We’ve been steadily making progress in the clinic to prove out this novel technology and mechanism. With respect to CMTX-101, we first completed a Phase 1a in 20 healthy volunteers in 2023. Recently, in Q1 2024, we began a Phase 1b trial focused specifically on individuals with cystic fibrosis who are chronically infected with Pseudomonas aeruginosa. This study involved 41 subjects, and we just completed the Phase 1b portion, having dosed our first patient in the 2a trial just yesterday. This study is not only looking at safety but also early signals of efficacy regarding bacterial load and sputum. Additionally, we have recently completed our Phase 1b study in bacterial pneumonia, which combined safety assessments with our Phase 1a findings. The topline results showed not only safety but also encouraging trends in key inflammatory biomarkers, including IL-6, PCT, and CRP. While this was a small study, we are encouraged by the results.”
Looking forward, Richards elaborated on the broader implications of their therapeutic approach: “The beauty of this approach, to reiterate, is that it targets a highly conserved protein across bacterial species. With a single therapeutic like CMTX-101 or a vaccine with CMTX-301, we have the potential to cover a wide range of pathogens. Initially, with CMTX-101, we’re focusing on the chronic respiratory space. We believe we can intervene in bronchiectasis, which is common in cystic fibrosis and non-CF bronchiectasis, as well as in anti-M lung disease. By addressing chronic bronchial infections—an integral part of the vicious cycle that leads to lung function decline and increased mortality—we aim to improve outcomes and reduce therapy regimens in these patients. We see potential for this approach to extend to other bacterial infections, including prosthetic joint infections and skin diseases.”
In conclusion, Richards emphasized the transformative potential of their research, stating, “We think we have a truly novel category of therapy and vaccine that, if our preclinical data translates, could really change treatment paradigms in the clinic.” Clarametyx’s dedication to combating bacterial biofilms aligns with its strategic mission to address chronic infections. The company has also recently completed a study of CMTX-101 for community-acquired bacterial pneumonia, which yielded promising safety and efficacy data.
