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Re: TheFinalCD post# 532

Thursday, 04/27/2023 6:06:27 AM

Thursday, April 27, 2023 6:06:27 AM

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ContraFect Announces First Patient Dosed in the Phase 1b/2 Study of Exebacase in Patients with Chronic Prosthetic Joint Infections of the Knee
YONKERS, N.Y., April 26, 2023 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, today announces the first patient has been dosed in the Phase 1b/2 of exebacase in the setting of an arthroscopic debridement, antibiotics, irrigation, and retention (DAIR) procedure in patients with chronic prosthetic joint infections (PJI) of the knee due to Staphylococcus aureus (S. aureus) or Coagulase-Negative Staphylococci (CoNS).

“We are pleased by the rapid enrollment of the first patient in our PJI study of exebacase,” said Roger J. Pomerantz, MD, President, Chief Executive Officer, and Chairman of ContraFect. “It is important to understand that surgical revision of the infected prosthesis, the current standard of care for chronic PJI, has barely improved clinical outcomes over the past several decades. We believe exebacase has the potential to replace this debilitating and expensive surgical procedure, eradicate the infection, and significantly improve quality of life for patients with chronic PJIs suffering from pain and loss of mobility.”

The Phase 1b/2 study of exebacase is a randomized, double-blind, placebo-controlled clinical study conducted in France to assess the safety, pharmacokinetics (PK), and efficacy of intra-articularly administered exebacase in patients with chronic PJI of the knee due to S. aureus or CoNS. The study will be conducted in two parts. Part I will assess efficacy at an early, six-week timepoint in addition to safety and PK. Part II will be a long-term clinical safety and efficacy follow-up for a period of up to two years. Patients entering the study will be randomized 3:1 to either exebacase or placebo, with all patients receiving study drug in the setting of a DAIR Procedure.

Data from compassionate use cases is available in the Publications & Posters and Presentations sections of the Company’s website.
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