ContraFect Announces First Gram-negative Product Candidate CF-370, a Direct Lytic Agent Targeting Pseudomonas aeruginosa
Pre-Clinical Data Demonstrate Efficacy and Tolerability as a Potential Targeted Therapeutic for serious infections caused by multi-drug resistant P. aeruginosa
YONKERS, N.Y., Dec. 18, 2019 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq:CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, today announced that it has selected its next product candidate, CF-370, an engineered lysin targeting Pseudomonas aeruginosa (P. aeruginosa). CF-370 was nominated for further development based on its potent in vitro bactericidal and antibiofilm activity and in vivo activity and tolerability in preclinical animal models, favorable manufacturing profile, and potentially favorable intellectual property rights for a proprietary engineered lysin. The Company will rapidly advance CF-370 into IND-enabling studies, as the first lysin with potential to address systemic human infections caused by the Gram-negative pathogen P. aeruginosa. The Company expects to present the detailed preclinical data supporting the advancement of CF-370 at an upcoming scientific conference.
“We are excited to announce the nomination of CF-370 as our next product candidate. The compelling preclinical findings showed potent activity against resistant P. aeruginosa both in vitro and in vivo, as well as excellent tolerability in animals,” said Cara Cassino, MD, ContraFect’s Chief Medical Officer and Executive Vice President of Research & Development. “We believe CF-370 offers a potential new therapeutic modality to address the unmet need for treatment of serious systemic infections caused by multi-drug resistant P. aeruginosa, which is listed as a serious threat in the CDC’s 2019 Antibiotic Resistance Threats Report.”
In preclinical rabbit pneumonia models, single doses of CF-370 alone and in combination with the antibiotic, meropenem, were tested against multi-drug resistant P. aeruginosa to evaluate survival and bacterial burden in lung and secondary organs. In these models, strong efficacy was observed for CF-370 as a monotherapy, showing rabbits dosed with CF-370 alone had longer survival, as compared to vehicle control, and reductions in bacterial burden in lung, kidney and spleen with single doses of CF-370. Synergy with meropenem was also noted with greater reductions in bacterial burden compared to monotherapy. In these models, CF-370 was well tolerated with no adverse clinical consequences and no deaths among animals infected with P. aeruginosa.
ContraFect is a biotechnology company focused on discovering and developing differentiated biologic therapies for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. We intend to address life threatening infections using our therapeutic product candidates from our platform of DLAs, which include lysins and amurin peptides. Lysins are a new class of DLAs which are recombinantly produced antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics. Amurin peptides are a new class of DLAs, which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, including Pseudomonas aeruginosa (P. aeruginosa), Acinetobacter baumannii, and Enterobacter species. We believe that the properties of our lysins and amurin peptides will make them suitable for targeting antibiotic-resistant organisms, such as methicillin-resistant Staph aureus (MRSA) and P. aeruginosa, which can cause serious infections such as bacteremia, pneumonia and osteomyelitis. We have completed a Phase 2 clinical trial for the treatment of Staph aureus bacteremia, including endocarditis, with our lead lysin candidate, exebacase (CF-301), which is the first lysin to enter clinical studies in the U.S.
About Pseudomonas aeruginosa (P. aeruginosa):
P. aeruginosa is a gram-negative pathogen which readily develops resistance to conventional antibiotics resulting in the emergence of multidrug resistant (“MDR”) strains, which have become common in many hospitals and regions. P. aeruginosa is a major cause of hospital-acquired infections and is a particularly important cause of infections in immunocompromised hosts and is also a major pathogen in burn and surgical wound infections. P. aeruginosa is the most common pathogen isolated from adults with cystic fibrosis, and is the most common cause of respiratory failure in cystic fibrosis and responsible for the deaths of the majority of these patients.
Invasive P. aeruginosa infections, including ventilator associated pneumonia, blood stream infections, complicated urinary tract infections, and infections following surgery carry some of the highest rates of mortality among hospital acquired infections. Infections caused by multidrug resistant P. aeruginosa are associated with high all-cause mortality, hospital mortality and higher health-care related costs, as compared to infections caused by susceptible strains.
This press release contains, and our officers and representatives may make from time to time, “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. Examples of forward-looking statements in this release include, without limitation, statements regarding ContraFect’s End-of-Phase 2 Meeting with the FDA, Phase 3 plans, designs, results and timing, statements made regarding ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, statements made regarding CF-370, including ContraFect’s ability to advance CF-370 into IND enabling studies and the presentation of pre-clinical data, statements made by ContraFect’s chief executive officer and chief medical officer, ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, the planned call and webcast, in vitro and in vivo study results, ContraFect’s ability to address life threatening infections using its therapeutic product candidates from its DLA platform, whether lysins are a new class of DLAs which are recombinantly produced, antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics, whether amurins exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, and whether the properties of ContraFect’s lysins and amurins will make them suitable for targeting antibiotic-resistant organisms, such as Staph aureus and P. aeruginosa., the potential for exebacase to be a first-in-class treatment for Staph aureus bacteremia, statements made regarding exebacase and Phase 2 study results. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect’s current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control, including those detailed under the caption “Risk Factors” in ContraFect's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, among others, our ability to develop treatments for drug-resistant infectious diseases. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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Released December 18, 2019