Clarametyx Announces FDA Acceptance of Investigational New Drug (IND) Application for Phase 1 Study of Immune-Enabling Antibody Therapy CMTX-101
COLUMBUS, Ohio--(BUSINESS WIRE)--Clarametyx Biosciences Inc. (“Clarametyx”), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application to initiate a first-in-human Phase 1 safety study followed by a Phase 1b trial of CMTX-101, a novel immune-enabling antibody therapy.
Following a brief Phase 1 safety evaluation in healthy volunteers, the Phase 1b trial will aim to provide important safety as well as exploratory efficacy data on the use of CMTX-101 among individuals hospitalized with community-acquired bacterial pneumonia.
“We’ve made tremendous progress with the early development of this potentially game-changing technology to specifically address bacterial biofilms, which is a major driver of resistance in bacterial infections,” said David Richards, Chief Executive Officer, Clarametyx. “With IND acceptance, we are now advancing as a clinical-stage company and can accelerate our efforts to identify the optimal application of this technology to enhance antibiotic approaches, with the potential for significant impact in treating severe bacterial infections and improving health outcomes.”
According to the National Institutes of Health, bacterial biofilms are responsible for approximately 80% of human bacterial infections, including bacterial pneumonia, cystic fibrosis-related bacterial infection, COPD-related respiratory infections, chronic sinusitis and otitis media, and chronic wound-related infections. Collectively, these infections contribute substantial costs to the healthcare system due to significantly increased hospitalization rates and lengths of stay, as well as increased morbidity and mortality. Clarametyx is focusing first on challenging respiratory infections.
CMTX-101 is an immune-enabling 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 across bacteria, the technology can be employed 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 concomitantly with a wide range of standard-of-care antibiotics that target both Gram-negative and Gram-positive bacteria. The goal of treatment is to dramatically improve the effectiveness of antibiotic therapies and patient innate immune system effectors from the onset of CMTX-101 administration, improving the time to resolution of the infection and reducing the need for repeated courses of antibiotics.
Acknowledgement and disclaimer
The milestone reported in this news release was supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this news release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those 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 is combating the formidable challenge of persistent and recalcitrant infections through an innovative technology platform targeting the 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 pipeline of immune-enabling therapies and vaccines for life-threatening bacterial infections associated with biofilms, with a near-term focus on challenging respiratory infections. For more information, visit us on the web or on LinkedIn.