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Independent DSMB recommends exebacase phase III trial be stopped for futility following interim analysis.- ContraFect Corporation,

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Published:17th Jul 2022

ContraFect Corporation announces 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.

The company will nevertheless conduct an analysis of the accrued study data and said it would provide further details regarding the development of the drug after the analysis was complete.

Condition: Infectious Diseases/.Staph.Aureus
Type: drug

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