ContraFect Corporation CFRX has announced the database lock of its Phase 3 DISRUPT study of exebacase in patients with Staph aureus bacteremia, along with a summary of topline data from the interim futility analysis.
The results from the Futility Dataset and the company’s analysis are based on 55 patients who were treated with exebacase plus standard of care (SOC) antibiotics (the Exebacase Arm) and 29 patients treated with placebo plus SOC antibiotics (the SoCA Arm).
Clinical response at day 14 was 52.7% in the Exebacase Arm compared to 58.6% in the SoCA Arm.
The company said there was an imbalance in the baseline disease severity of patients, with 34.8% of patients in the Exebacase Arm having an APACHE II score >15, compared to only 13.8% of patients in the SoCA Arm.
A patient with an APACHE II score above 15 is considered to have an extremely poor prognosis and a significantly increased mortality risk.
Subgroup analyses of clinical response were all as expected, based on the topline results, other than APACHE II subgroups.
Pharmacokinetic data confirmed proper study randomization and drug allocation.
“The unprecedented clinical response in the placebo arm of this study, which is nearly double the response rate observed in our Phase 2 study of exebacase and comparable Phase 3 studies of daptomycin and fosfomycin, coupled with the conduct of the study during the COVID pandemic, leaves us with trial results that are uninterpretable,” said Roger Pomerantz, President, CEO & Chairman of ContraFect.
The full results will be coming in the first quarter.
The company said another study on this patient population should be conducted in the future.
Price Action: CFRX shares are down 0.48% at $0.1040 on the last check Tuesday.
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