ContraFect Announces Presentation of New Clinical Data From a Study Using Exebacase in the LysinDAIR Procedure on Patients With Chronic Knee Prosthetic Joint Infection
ContraFect Corporation (CFRX) presented positive data on its LysinDAIR procedure for treating chronic knee prosthetic joint infections (PJI) at the European Bone and Joint Infection Society meeting. The exploratory study showed no serious adverse events related to exebacase in patients. In one cohort of patients, no relapses were reported up to 36 months post-treatment. The results suggest potential for exebacase in blinded clinical studies targeting MRSA and coagulase-negative staph infections. Further randomized clinical trials are warranted to validate these findings and explore therapeutic potential.
- Positive clinical data from the LysinDAIR procedure show no significant adverse events related to exebacase.
- Patients showed no relapse of infection or prosthesis loosening for up to 36 months in one cohort.
- The study highlights potential for further clinical investigation of exebacase in treating chronic PJI.
- In the second cohort, one patient experienced a relapse of infection after six months.
- A patient died from an unrelated COVID-19 infection during the study period.
YONKERS, N.Y., Sept. 12, 2022 (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, announces today the presentation by Dr. Tristan Ferry of the Infectious and Tropical Diseases Unit, Croix-Rousse Hospital, Hôspices Civils de Lyon in Lyon, France at the 40th Annual Meeting of the European Bone and Joint Infection Society, held in Graz, Austria from September 8-10, 2022, of data from a single center, exploratory, open-label prospective study using a minimally invasive LysinDAIR procedure in patients with chronic knee prosthetic joint infection (PJI), due to coagulase-negative staphylococci (CoNS), with two different clinical presentations and treatment paradigms.
“The positive clinical data demonstrated in these patients underpins the potential to prosecute exebacase in a blinded clinical study of patients with chronic or recurrent prosthetic joint infections caused by MRSA or coagulase-negative Staph,” stated Roger J. Pomerantz, M.D., ContraFect’s President, Chief Executive Officer, and Chairman. “I am particularly impressed with the durability of patient responses to therapy, in some cases out to 36 months, allowing patients to avoid expensive and potentially debilitating joint removal and reimplantation,” added Dr. Pomerantz.
The presentation outlines the results from two cohorts, each consisting of four patients with chronic CoNS knee PJI (i.e., infections of longer than three months prior to treatment), who each received the LysinDAIR procedure (arthroscopic debridement with retention of the implant, followed by intra-articular administration of exebacase and systemic antibiotic therapy).
The first cohort included patients suffering their first episode of CoNS knee PJI. The Lysin DAIR procedure was followed by three months of clindamycin and levofloxacin. Exebacase was well tolerated by all patients. No local or systemic serious adverse events (SAEs) related to exebacase were reported. The patients, through follow up periods of up to 36 months, have experienced no relapse of infection, no recurrence of the joint effusion and no loosening of the prostheses.
The second cohort included patients suffering from a complex episode of multi-drug resistant CoNS knee PJI. The LysinDAIR procedure was followed by three months of antibiotics plus additional suppressive antimicrobial therapy. Exebacase was well tolerated by all patients. No local or systemic SAEs related to exebacase were reported. Two patients, through follow up periods of up to 12 months, have experienced no relapse of infection, no recurrence of the joint effusion and no loosening of the prostheses. One patient experienced a relapse of infection of Staphylococcus caprae after six months. One patient died from an unrelated COVID-19 infection.
The authors concluded that the minimally invasive LysinDAIR procedure was easy to perform, well tolerated, and may have therapeutic potential to facilitate the success of salvage therapy for chronic relapsing CoNS prosthetic knee infections. Randomized clinical trials evaluating the LysinDAIR procedure in these patients are clearly warranted.
The meeting presentation referenced above will be available on the ContraFect website.
About ContraFect:
ContraFect is a biotechnology company focused on the discovery and development of DLAs, including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. We intend to address life threatening infections using our therapeutic product candidates from our platform of DLAs, which include lysins and amurin peptides. Lysins are a new class of DLAs which are recombinantly produced antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics. Amurin peptides are a novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, including P. aeruginosa, Acinetobacter baumannii, and Enterobacter species. We believe that the properties of our lysins and amurin peptides will make them suitable for targeting antibiotic-resistant organisms, such as MRSA and P. aeruginosa, which can cause serious infections such as bacteremia, pneumonia and osteomyelitis. We have completed a Phase 2 clinical trial for the treatment of Staph aureus bacteremia, including endocarditis, with our lead lysin candidate, exebacase, which is the first lysin to enter clinical studies in the U.S. Exebacase was 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.
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Forward-Looking Statements
This press release contains, and our officers and representatives may make from time to time, “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. Examples of forward-looking statements in this release include, without limitation, statements regarding the presentation, study results, statements made by Dr. Pomerantz, ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, whether the LysinDAIR procedure will have therapeutic potential to facilitate the success of salvage therapy for chronic relapsing CoNS prosthetic knee infections, whether ContraFect will address life-threatening infections using therapeutic candidates from its DLA platform, whether lysins are a new class of DLAs which are recombinantly produced, antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics, whether amurins are a novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, and whether the properties of ContraFect’s lysins and amurins will make them suitable for targeting antibiotic-resistant organisms, such as MRSA and P. aeruginosa. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect’s current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control, including the occurrence of any adverse events related to the discovery, development and commercialization of ContraFect’s product candidates such as unfavorable clinical trial results, insufficient supplies of drug products, the lack of regulatory approval, or the unsuccessful attainment or maintenance of patent protection and other important risks detailed under the caption “Risk Factors” in ContraFect's Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 and its other filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Relations Contacts:
Michael Messinger
ContraFect Corporation
Email: mmessinger@contrafect.com
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