ContraFect announces ANSM approval of CTA for exebacase

ContraFect Corporation announces that ANSM, the French National Agency for the Safety of Medicines and Health Products, has authorized its Clinical Trial Application for the study of intra-articularly administered exebacase, in the setting of a minimally-invasive arthroscopic debridement, antibiotics, irrigation, and retention procedure in patients with chronic prosthetic joint infection of the knee due to Staphylococcus aureus or Coagulase-Negative Staphylococci. The Phase 1b/2 study of exebacase is a randomized, double-blind, placebo-controlled two-part clinical study to be conducted in France to assess the efficacy and safety of exebacase in the setting of an arthroscopic DAIR procedure in patients with chronic PJI of the knee due to S. aureus and/or CoNS. Part 1 will evaluate the safety, PK, clinical outcomes, and microbiologic response in patients through Day 42. Up to 2 dose levels of intra-articularly administered exebacase in addition to systemic antibiotics will be studied in up to 2 patient cohorts. Part 2 will consist of a long-term follow-up study of safety and efficacy parameters in patients who complete Part 1 of the study. Follow-up assessments will be performed on Days 90, 180, 360 and 720.