ContraFect Corporation 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.