FDA accepts IND application for Clarametyx antibody therapy CMTX-101

Clarametyx Biosciences has announced that the US Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application to initiate a first-in-human Phase I safety study followed by a Phase Ib trial of CMTX-101, a novel immune-enabling antibody therapy to treat individuals hospitalised with community-acquired bacterial pneumonia.

Following a brief Phase I safety evaluation in healthy volunteers, the Phase Ib trial will aim to provide important safety as well as exploratory efficacy data. 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 defences and enable more effective antibiotic and immune intervention. As the target is universally present across bacteria, the technology can be employed to treat a range of bacterial infections, many of which are characterised 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.

“We have 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 of 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 US National Institutes of Health, bacterial biofilms are responsible for approximately 80 percent of human bacterial infections, including bacterial pneumonia, cystic fibrosis-related bacterial infection, chronic obstructive pulmonary disease (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 hospitalisation rates and lengths of stay, as well as increased morbidity and mortality.