ContraFect Shares Plummet After Data Safety Monitoring Board Stops Late-Stage Staph Aureus Bacteremia Study

ContraFect Shares Plummet After Data Safety Monitoring Board Stops Late-Stage Staph Aureus Bacteremia Study

The Data Safety Monitoring Board (DSMB) has recommended that ContraFect’s CFRX on going DISRUPT trial be stopped because the conditional power of the study was below the pre-specified threshold for futility.

The Phase 3 DISRUPT study is designed to assess the efficacy and safety of exebacase in approximately 350 patients with complicated S. aureus bacteremia.

The DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial) study has completed a pre-specified, interim futility analysis.

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.

Roger J. Pomerantz, President, Chief Executive Officer, commented : “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.”

The company is taking steps to inform the investigators that patient enrollment in the trial is being stopped based on the DSMB recommendation.

Price Action : ContraFect shares are trading down around 76 percent at $0.69 on Wednesday after-hours session.

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