ContraFect Announces Independent DSMB Recommends Exebacase Phase 3 DISRUPT Study Be Stopped for Futility Following Interim Analysis
YONKERS, N.Y., July 13, 2022 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq: CFRX), a 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, announces today that the Data Safety Monitoring Board (DSMB) of the DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial) study has completed a pre-specified, interim futility analysis and the DSMB recommended that the trial be stopped because the conditional power of the study was below the pre-specified threshold for futility.
The recommendation was based on an analysis of the clinical response rate at day 14 (the primary efficacy endpoint of the study) in 84 patients, or approximately 60% of the total planned methicillin-resistant Staphylococcus aureus (MRSA) population with bacteremia, including right-sided endocarditis. While further review of the data is ongoing, the company is initiating steps to notify investigators that patient enrollment in the trial is being stopped based on the DSMB recommendation.
“This disappointing news reflects the long history of difficulties in treating life-threatening infections like MRSA bacteremia in patients with heterogeneous co-morbidities, and who are in need of immediate life-saving treatments. We are sincerely grateful to all the patients, their families and the investigators who participated in the trial,” stated Roger J. Pomerantz, M.D., ContraFect’s President, Chief Executive Officer, and Chairman.
The company plans to provide further details regarding the development of exebacase following completion of its own analysis of the accrued study data.
The Phase 3 DISRUPT study of exebacase is a randomized, double-blind, placebo-controlled clinical study conducted in the U.S. to assess the efficacy and safety of exebacase in approximately 350 patients with complicated S. aureus bacteremia, including right-sided endocarditis. The primary efficacy endpoint is clinical response at Day 14 in patients with MRSA bacteremia, including right-sided endocarditis. Secondary endpoints include clinical response at Day 14 in the All S. aureus patients (MRSA and methicillin-sensitive S. aureus (MSSA)), 30-day all-cause mortality in MRSA patients, and clinical response at later timepoints.
ContraFect is a biotechnology company focused on the discovery and development of DLAs, including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections. 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 novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, including 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 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, which is the first lysin to enter clinical studies in the U.S. Exebacase was granted Breakthrough Therapy designation by the FDA for the treatment of MRSA bloodstream infections, including right-sided endocarditis, when used in addition to SOC anti-staphylococcal antibiotics.
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00021.
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 further details as to how ContraFect intends to proceed with the development of exebacase following full completion of its own analysis of all of the data sets from the Phase 3 clinical study of exebacase. 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 the occurrence of any adverse events related to the discovery, development and commercialization of ContraFect’s product candidates such as unfavorable clinical trial results, insufficient supplies of drug products, the lack of regulatory approval, or the unsuccessful attainment or maintenance of patent protection and other important risks detailed under the caption “Risk Factors” in ContraFect's Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 and its other filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. 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 July 13, 2022