ContraFect Wins BARDA Contract, Provides Business Outlook

 ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs) as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, today announced that it has been awarded a cost-share contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS). Under the terms of the contract, the Company will receive $9.8 million in initial funding and up to an additional $77.0 million. The initial funding will be used to support ContraFect’s ongoing pivotal Phase 3 DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial) superiority study of exebacase in patients with Staph aureus bacteremia, including right-sided endocarditis. Under the terms of the agreement, and if supported by Phase 3 DISRUPT study data, BARDA may provide the Company with additional funding upon achievement of key milestones to continue the advancement of exebacase through FDA product approval and completion of post-approval commitments.

“We are grateful for, and thrilled by, BARDA’s support to fund the advancement of exebacase toward the completion of our ongoing Phase 3 study and a potential product approval. This award represents a critical milestone and a transformational infusion of funds for ContraFect. Exebacase, which received Breakthrough Therapy Designation last year from the FDA, is the first direct lytic agent in Phase 3 trials and the lead program of our DLA platform, representing a completely new medical modality to address life-threatening infectious diseases. We believe that this award, and the expected acceleration of Phase 3 study enrollment, provides ContraFect with strong momentum as we move toward the interim futility analysis, currently anticipated in the second half of 2021,” said Roger J. Pomerantz, M.D., President, Chief Executive Officer, and Chairman of ContraFect.

“Antibiotic-resistant infections are rising at an alarming rate, and developing effective medical countermeasures against these infections has become one of the most pressing health security challenges of this century,” said BARDA Director Gary Disbrow, Ph.D. “ContraFect Corporation is the latest partner to work with BARDA on potential solutions to life-threatening infections and help save lives in future public health emergencies.”

Overview of Programs and Anticipated Milestones

Exebacase: a first-in-class recombinantly-produced lysin with the potential to become a new standard-of-care, compared to using antibiotics alone, for the treatment of Staph aureus bacteremia.

• In 2020, the Company began enrolling patients in the Phase 3 DISRUPT study and exebacase was granted Breakthrough Therapy designation by the FDA for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections, including right-sided endocarditis, when used in addition to standard-of-care anti-staphylococcal antibiotics in adult patients. The Phase 3 DISRUPT study 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 Staph aureus bacteremia, including right-sided endocarditis.
  

• Despite the onset of the COVID-19 pandemic shortly after the initiation of the DISRUPT study, the Company has continued to enroll patients and has expanded the number of clinical trial sites to over 40 sites across the United States. The pandemic has caused delays in patient enrollment, as hospitals have struggled to support intensive care units and the critical care of patients with severe COVID-19 infections. Assuming that the recent initiation of nationwide COVID-19 vaccinations expands to encompass a significant portion of the population, the Company believes the hospital burden will lighten during the first half of 2021 and expects an acceleration of DISRUPT study enrollment. ContraFect expects to conduct an interim futility analysis to assess the superiority of exebacase versus SOC alone, based on approximately 60% of the study population, in the second half of 2021. Topline data for the full study population are expected in 2022.
  

CF-370: a first-in-class, engineered lysin with the potential to become the first direct lytic agent in clinical development for the treatment of Pseudomonas aeruginosa infections.

• In 2020, the Company began IND-enabling activities to advance CF-370 towards clinical development and received a CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator) award for up to $18.9 million in non-dilutive capital to progress CF-370 through these activities.
  
  

• The Company continues to progress the IND-enabling studies of CF-370 towards completion and expects to initiate Phase 1 studies of CF-370 in the first half of 2022.
  

Amurin peptides: a new class of direct lytic agents with the potential to become an entirely new modality for broad-spectrum coverage of Gram-negative pathogens.

• Characterization of the Company’s lead amurin peptides is ongoing and the Company expects to select an amurin peptide as its next IND candidate by the end of 2021.
  

Conference Call and Webcast Information

ContraFect will host a live conference call and webcast at 8:30 a.m. ET on March 12, 2021. To access the live conference call, please dial (866) 691-5817 and refer to conference ID 4278833. A webcast of the call will also be available under “Events” in the Investors & Media section of the ContraFect website at www.contrafect.com. The archived webcast will be available on the Company’s website after the conference call.

https://finance.yahoo.com/news/contrafect-announces-barda-contract-award-210500328.html