ContraFect Corporation, a clinical-stage biotechnology company, has announced the launch of a Phase 1b/2 trial of exebacase in the context of a DAIR procedure for the treatment of chronic prosthetic joint infections of the knee caused by S. aureus or CoNS. This new trial is aimed at exploring the potential of direct lytic agents, such as lysins and amurin peptides, as powerful medical solutions for combating life-threatening, antibiotic-resistant infections.
We are thrilled to announce that we have initiated a trial for exebacase in patients with chronic PJI, marking yet another major milestone for the company. Prosthetic joint infections are notoriously difficult to treat, often requiring multiple surgeries or revisions of the prosthetic implant and resulting in significant loss of mobility and immobility for the patient.
We are hopeful that exebacase can provide a new treatment option to this patient population, potentially clearing biofilms and improving their quality of life.
With two programs now in clinical development, we look forward to advancing our second program CF-370 into Phase 1 study later this year, which could potentially be used to treat respiratory and other infections due to Gram-negative pathogens, including antibiotic-resistant strains.
The Phase 1b/2 study of exebacase is an exciting, randomized, double-blind, placebo-controlled clinical study exploring 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, while Part II will explore the long-term clinical safety and efficacy of the drug over the course of two years.
Patients will be randomized 3:1 to either exebacase or placebo, all of whom will receive the study drug in the setting of a DAIR Procedure. This is the perfect opportunity to evaluate the potential of this new treatment option, and to help improve the lives of those suffering from PJI of the knee.
About ContraFect
ContraFect is a biotechnology company revolutionizing the treatment of life-threatening, antibiotic-resistant infections with their novel, cutting-edge platform of DLAs. Lysins and amurin peptides are two types of DLAs that have been developed to rapidly kill target bacteria, eradicate biofilms, and work synergistically with conventional antibiotics.
In addition, lysins have been found to have broad-spectrum activity against a wide range of Gram-negative pathogens. Our lead lysin candidate, exebacase, is the first lysin to enter clinical studies in the U.S. and has been granted Breakthrough Therapy designation by the FDA for the treatment of MRSA bloodstream infections, including right-sided endocarditis, when used in addition to SOC anti-staphylococcal antibiotics.
We are proud to be leading the charge in tackling the global problem of antimicrobial-resistant infections, which are estimated to cause over 700,000 deaths each year.