Clarametyx Announces FDA Acceptance of Investigational New Drug (IND) Application for Phase 1 Study of Immunoactivating Antibody Therapy CMTX-101

Columbus, Ohio–(BUSINESS WIRE)–Clarametyx Biosciences Inc. (“Clarametyx”), a biotechnology company developing targeted, immune-enhancing biological therapies to address serious infections associated with biofilms, today announced that the United States Food and Drug Administration (FDA) has accepted the Company’s application for an Investigational New Drug (IND) to initiate a first-in-man Phase 1 safety study followed by a Phase 1b trial of CMTX-101, a new immuno-enhancing antibody therapy.

After a brief Phase 1 safety evaluation in healthy volunteers, the Phase 1b trial will aim to provide important safety data as well as exploratory efficacy data on the use of CMTX-101 in people hospitalized with community-acquired bacterial pneumonia.

“We have made tremendous progress with the early development of this potentially breakthrough technology to specifically address bacterial biofilms, which are a major resistance factor in bacterial infections,” said David Richards, CEO of Clarametyx. “With the acceptance of IND, we are now moving forward as a clinical-stage company and can accelerate our efforts to identify the optimal application of this technology to improve antibiotic approaches, with potential for significant impact in treatment. serious bacterial infections and improved health outcomes.

According to the National Institutes of Health, bacterial biofilms are responsible for approximately 80% of human bacterial infections, including bacterial pneumonia, bacterial infection linked to cystic fibrosis, respiratory infections linked to COPD, chronic sinusitis and otitis media, and chronic wound infections. . Collectively, these infections result in substantial costs to the healthcare system due to significantly increased hospitalization rates and lengths of stay, as well as increased morbidity and mortality. Clarametyx focuses first on difficult respiratory infections.

About the CMTX-101

CMTX-101 is an immuno-activating antibody therapy designed to precisely and rapidly destroy the universal underlying structure of bacterial biofilms to undermine extracellular bacterial defenses and enable more effective antibiotic and immune intervention. Because the target is universally present in bacteria, the technology can be used to treat a range of bacterial infections, many of which are characterized by the presence of multiple types of bacteria. CMTX-101 is intended to be administered alongside a wide range of standard antibiotics that target both Gram-negative and Gram-positive bacteria. The treatment goal is to dramatically improve the efficacy of antibiotic therapies and patient innate immune system effectors from the start of CMTX-101 administration, improving the time to resolution of infection and reducing the need for repeated courses of antibiotics.

Acknowledgments and Disclaimer

The milestone reported in this press release was supported by CARB-X. CARB-X funding for this project is provided in part by federal funds from the Department of Health and Human Services; Administration of Strategic Preparedness and Response; Advanced Biomedical Research and Development Authority; under grant number: 75A50122C00028, and by awards from Wellcome (WT224842) and the German Federal Ministry of Education and Research (BMBF). The contents of this press release are the sole responsibility of the authors and do not necessarily represent the official views of CARB-X or any of its funders.

About CARB-X

CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global, not-for-profit partnership dedicated to supporting early-stage antibacterial research and development to address the growing threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X only funds projects that target drug-resistant bacteria on the CDC’s list of antibiotic-resistant threats or the list of priority bacterial pathogens published by the WHO, with priority on pathogens deemed serious or urgent on the CDC list or critical or high. on the WHO list. https://carb-x.org/ | Twitter @CARB_X

About Clarametyx Biosciences

Clarametyx Biosciences tackles the formidable challenge of persistent and recalcitrant infections with an innovative technology platform targeting biofilm – a protective layer around bacteria – to enable a more effective immune response or antibiotic intervention. The Columbus, Ohio-based company is building a dynamic portfolio of immune-enhancing therapies and vaccines for life-threatening bacterial infections associated with biofilms, with a near-term focus on difficult respiratory infections. For more information, visit us on the Web Or on LinkedIn.