ContraFect shares plummet after data safety watchdog halts study of late-stage Staphylococcus aureus bacteremia
The Data Safety Monitoring Board (DSMB) has recommended that the ongoing CFRX DISRUPT trial of ContraFect be stopped because the conditional power of the study was below the threshold for futility preset.
The Phase 3 DISRUPT study is designed to evaluate the efficacy and safety of exebacase in approximately 350 patients with complicated S. aureus bacteremia.
The Direct Lysis of Staph aureus Resistant Pathogen Trial (DISRUPT) study performed a predefined 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 count of predicted methicillin-resistant staphylococci aureus (MRSA) with bacteremia, including right-sided endocarditis.
Roger J. Pomerantz, Chairman and CEO, said, "This disappointing news reflects the long history of difficulties in treating life-threatening infections like MRSA bacteremia in patients with heterogeneous comorbidities, and who need immediate life-saving treatment. We are sincerely grateful to all the patients, their families and the investigators who participated in the trial."
The company is taking steps to notify investigators that patient enrollment in the trial is halted based on the DSMB's recommendation.
Price Action: ContraFect shares are trading down around 76% at $0.69 in Wednesday's after-hours session.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
The Data Safety Monitoring Board (DSMB) has recommended that the ongoing CFRX DISRUPT trial of ContraFect be stopped because the conditional power of the study was below the threshold for futility preset.
The Phase 3 DISRUPT study is designed to evaluate the efficacy and safety of exebacase in approximately 350 patients with complicated S. aureus bacteremia.
The Direct Lysis of Staph aureus Resistant Pathogen Trial (DISRUPT) study performed a predefined 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 count of predicted methicillin-resistant staphylococci aureus (MRSA) with bacteremia, including right-sided endocarditis.
Roger J. Pomerantz, Chairman and CEO, said, "This disappointing news reflects the long history of difficulties in treating life-threatening infections like MRSA bacteremia in patients with heterogeneous comorbidities, and who need immediate life-saving treatment. We are sincerely grateful to all the patients, their families and the investigators who participated in the trial."
The company is taking steps to notify investigators that patient enrollment in the trial is halted based on the DSMB's recommendation.
Price Action: ContraFect shares are trading down around 76% at $0.69 in Wednesday's after-hours session.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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