ContraFect Initiates Expanded Access to Exebacase for the Treatment of MRSA Bloodstream Infections in COVID-19 Patients

Rhea-AI Summary

ContraFect Corporation (Nasdaq: CFRX) announced the initiation of an expanded access program for exebacase, targeting persistent bacteremia caused by Staphylococcus aureus (MRSA) in COVID-19 patients. This follows FDA's Breakthrough Therapy designation for exebacase. The expanded access allows severely ill COVID-19 patients, ineligible for the ongoing Phase 3 study, to access treatment. Results from a Phase 2 study indicate exebacase may improve clinical outcomes and reduce mortality in MRSA bacteremia cases. The company also continues compassionate use programs for patients with chronic post-operative infections.

Positive

• FDA granted Breakthrough Therapy designation for exebacase in treating MRSA bloodstream infections.
• Expanded access program allows COVID-19 patients with MRSA bacteremia to receive exebacase.
• Phase 2 study showed a clinical responder rate increase of 43% for patients treated with exebacase compared to standard care.
• Potential reduction in 30-day all-cause mortality by 21% in MRSA patients treated with exebacase.

Negative

• None.

YONKERS, N.Y., Oct. 26, 2020 (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 announced that it has initiated an expanded access program to provide exebacase for the treatment of persistent bacteremia caused by methicillin-resistant Staphylococcus aureus (MRSA) in COVID-19 patients. Exebacase has been granted Breakthrough Therapy designation for the treatment of MRSA bloodstream infections by the U.S. Food and Drug Administration (FDA). The Company is providing expanded access to exebacase under a treatment protocol available to clinical sites participating in the ongoing Phase 3 study, which enables physicians to use exebacase to treat severely ill COVID-19 patients with persistent MRSA bacteremia, despite treatment with standard of care antibiotics. These patients who are hospitalized with COVID-19 may now have access to exebacase since they are not eligible to participate in the ongoing Phase 3 study. Based on the results of the completed Phase 2 study, the Company believes that treatment with exebacase in addition to anti-staphylococcal antibiotics has the potential to improve clinical outcomes for many COVID-19 patients who have persistent MRSA bacteremia. More information about the program is available at www.clinicaltrials.gov (NCT04597242).

Roger J. Pomerantz, M.D., F.A.C.P., President, Chief Executive Officer, and Chairman of ContraFect said, “As a company dedicated to defeating serious infectious diseases, it is our responsibility to actively attempt to help severely ill patients with COVID-19. Exebacase has the potential to treat MRSA superinfections in patients infected with COVID-19, a significant cause of severe disease. This enduring crisis, in addition to the upcoming flu season, demands that our potential breakthrough therapy be accessible to all patients who have life-threatening MRSA bacteremia, and we are hopeful that exebacase could have a favorable impact on patient outcomes.”

Respiratory viral infections, such as influenza, SARS and MERS, are commonly associated with secondary infections, or superinfections, by opportunistic pathogens. During previous influenza epidemics, including the 1918-19 “Spanish Flu” pandemic, the majority of deaths likely resulted directly from secondary bacterial pneumonia^1,2. While there is currently limited data, secondary bacterial infections have been noted in China over the course of the COVID-19 pandemic with up to 50% of patients who died experiencing a secondary infection^3,4. This potential role of bacterial superinfections in the clinical outcomes of COVID-19 patients has been recently recognized as an emerging issue in the U.S.^5,6. Staph aureus is one of the most common pathogenic causes of secondary bacterial infections in patients suffering from severe respiratory viral infections.

This represents another compassionate use program for exebacase. ContraFect continues to provide early access to exebacase to individual named patients with chronic post-operative prosthetic joint infections (PJIs) under Temporary Authorizations for Use from the French National Agency for Medicines and Health Products Safety obtained by Dr. Tristan Ferry at the Hôpital de la Croix Rousse in Lyon, France. Staphylococcal PJIs pose significant treatment challenges due to biofilm formation, which renders conventional antibiotics ineffective and necessitates surgical removal and replacement of the prosthetic joint. There are medicinal therapies approved by FDA for the treatment of PJIs and surgical intervention (e.g. removal and replacement of the infected joint) is the current standard of care. Through this compassionate use program, ContraFect is able to gain an early assessment of the safety of intra-articular administration of exebacase and potential early signs of efficacy of exebacase as a potential therapeutic agent for PJIs.

About Exebacase (CF-301):

Exebacase is a recombinantly-produced lysin (cell wall hydrolase enzyme) with potent bactericidal activity against Staph aureus, a major cause of bloodstream infections (BSIs) also known as bacteremia. In the Company’s Phase 2 study of exebacase, a pre-specified analysis of MRSA-infected patients showed that the clinical responder rate at Day 14 in patients treated with exebacase was nearly 43-percentage points higher than in patients treated with standard-of-care (SOC) antibiotics alone (74.1% for patients treated with exebacase compared to 31.3% for patients treated with SOC antibiotics alone (p=0.010)). In addition to the higher rate of clinical response, MRSA-infected patients treated with exebacase showed a 21-percentage point reduction in 30-day all-cause mortality (p=0.056), a four-day lower mean length of hospital stay and meaningful reductions in hospital readmission rates. Exebacase is currently being studied in the Phase 3 DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial) superiority design study of exebacase in patients with Staph aureus bacteremia, including right-sided endocarditis.

Exebacase has the potential to be a first-in-class treatment for Staph aureus bacteremia. Exebacase was licensed from The Rockefeller University and is being developed at ContraFect.

About DISRUPT:

The Phase 3 DISRUPT study of exebacase is a randomized, double-blind, placebo-controlled clinical study conducted in the U.S. to assess the efficacy and safety of exebacase in approximately 350 patients with complicated Staph aureus bacteremia, including right-sided endocarditis. Patients enrolled in the Phase 3 study are randomized 2:1 to receive either exebacase or placebo, with all patients receiving SOC antibiotics. The primary efficacy endpoint of the study is clinical response at day 14 in patients with MRSA bacteremia, including right-sided endocarditis. Secondary endpoints include clinical response at day 14 in the all Staph aureus patients (MRSA and methicillin-sensitive Staph aureus (MSSA)), 30-day all-cause mortality in MRSA patients, and clinical response at later timepoints. The company plans to conduct an interim futility analysis following the enrollment of approximately 60% of the study population.

About ContraFect:

ContraFect is a 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. 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 Pseudomonas aeruginosa (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, currently being studied in a pivotal Phase 3 clinical study, 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 in adult patients.

Follow ContraFect on Twitter @ContraFectCorp and LinkedIn.

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: ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, whether the Company will initiate the expanded access program and provide expanded access to exebacase for COVID-19 patients, whether physicians will use exebacase to treat COVID-19 patients, whether hospitalized COVID-19 patients will have access to exebacase, whether treatment with exebacase in addition to anti-staphylococcal antibiotics has the potential to improve clinical outcomes for many COVID-19 patients who have persistent MRSA bacteremia, statements made by Dr. Pomerantz, statements related to secondary infections and their cited references, whether Staph aureus is one of the most common pathogenic causes of secondary bacterial infections in patients with severe respiratory viral infections, whether the Company continues to provide early access to exebacase to individual named patients with PJIs under ATUs, whether ContraFect will gain an early assessment of the safety of intra-articular administration of exebacase and early signs of efficacy of exebacase as a therapeutic agent, whether exebacase has the potential to be a first-in-class treatment for exebacase, whether ContraFect will address life-threatening infections using 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 those detailed under the caption “Risk Factors” in ContraFect's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, among others, our ability to develop treatments for drug-resistant infectious diseases. 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.

References:

1. David M. Morens, Jeffery K. Taubenberger, and Anthony S. Fauci (2008). Predominant Role of Bacterial Pneumonia as a Cause of Death in Pandemic Influenza: Implications for Pandemic Influenza Preparedness. Journal of Infectious Diseases 198(7): 962–970.
2. Denise E. Morris, David W. Cleary and Stuart C. Clarke (2017). Secondary Bacterial Infections Associated with Influenza Pandemics. Frontiers in Microbiology, June 2017, Volume 8, Article 1041.
3. Fei Zhou, Ting Yu, Ronghui Du, et al (2020). Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. The Lancet. Published online March 9, 2020 https://doi.org/10.1016/S0140-6736(20)30566-3.
4. Xiaobo Yang, Yuan Yu, Jiqian Xu, et al (2020). Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. The Lancet. Published Online February 21, 2020 https://doi.org/10.1016/S2213-2600(20)30079-5.
5. Kenneth Thorpe (2020). Industry Voices—Another enemy emerges in the COVID-19 fight: Antibiotic-resistant bugs. Fierce Healthcare https://www.fiercehealthcare.com/hospitals-health-systems/industry-voices-another-enemy-emerges-covid-19-fight-antibiotic-resistant
6. Dr. Julie Gerberding (2020). Antibiotic resistance: the hidden threat lurking behind Covid-19. STAT https://www.statnews.com/2020/03/23/antibiotic-resistance-hidden-threat-lurking-behind-covid-19/
   

Investor Relations Contacts

Michael Messinger
ContraFect Corporation
mmessinger@contrafect.com

Carlo Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallinvestorrelations.com

FAQ

What is the significance of the expanded access program for CFRX?

The expanded access program allows severely ill COVID-19 patients with persistent MRSA bacteremia to access exebacase, despite being ineligible for the Phase 3 study.

What does the FDA's Breakthrough Therapy designation mean for CFRX?

The Breakthrough Therapy designation indicates that exebacase could offer significant benefits over existing treatments for MRSA bloodstream infections.

What were the results of the Phase 2 study for exebacase?

The Phase 2 study demonstrated a 43% higher clinical responder rate for MRSA patients treated with exebacase compared to standard of care, and a 21% reduction in 30-day mortality.

How does exebacase work against MRSA infections?

Exebacase is a lysin that targets and kills Staphylococcus aureus bacteria, which are common causes of severe infections.