ContraFect announces FDA clearance of CF-370 IND application

ContraFect announces that the U.S. Food and Drug Administration, FDA, has notified the company that it has completed the safety review of its Investigational New Drug, IND, application for CF-370 for the treatment of hospital-acquired bacterial pneumonia, HABP, and ventilator-associated bacterial pneumonia, VABP, and concluded that the company may proceed with its Phase 1 clinical study. This milestone is significant for ContraFect and historic in the field of non-traditional antibacterial therapies, as CF-370 will be the first engineered lysin therapeutic targeting Gram-negative pathogens to enter a human clinical trial. CF-370 has demonstrated potent in vitro activity against Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, Escherichia coli and Enterobacter cloacae and across numerous animal models of pneumonia, including efficacy against multi-drug resistant strains. ContraFect is a global innovator in the discovery and development of DLAs, leading the field with an intellectual property portfolio which includes thirty U.S. patents, one hundred and fifty-four issued foreign patents and two hundred and forty-six pending U.S. and international patent applications. The company’s discovery platform and functional expression library are designed to enable the construction and identification of novel therapeutic proteins that can penetrate the outer membrane of Gram-negative bacteria, resulting in lysis and prokaryotic cell death. CF-370 represents the first product candidate to be developed using the company’s proprietary technologies.