Ness Ziona, Israel and Chapel Hill, NC – September 25, 2017 – Atox Bio today announced that it has been awarded the next option on a performance-based contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of Reltecimod in patients with Necrotizing Soft Tissue Infections (NSTI). The award of this option brings the current commitment from BARDA to $20 million. The contract covers the pivotal Phase 3 study of Reltecimod, manufacturing and regulatory activities. “We appreciate and continue to benefit from BARDA’s ongoing support in the development of Reltecimod as a novel, host-based, immunomodulatory therapy to treat severe infections,” said Dan Teleman, Chief Executive Officer of Atox Bio. “We have a very collaborative partnership with BARDA and look forward to continuing to work together.”
Reltecimod (AB103) is a rationally designed peptide that binds to the CD28 co-stimulatory receptor to modulate the host’s immune response to severe infections. By limiting, but not inhibiting, the body’s acute inflammatory response, Reltecimod helps control the cytokine storm that could quickly lead to morbidity and mortality.
Reltecimod received Orphan Drug status from the FDA and EMA as well as Fast Track designation.
About NSTI NSTIs, commonly referred to as “flesh eating bacteria”, represent the most severe, rare types of infections involving the skin, skin structure and soft tissues. NSTIs progress rapidly and often result in significant tissue destruction and systemic disease leading to multiple organ dysfunction, failure and death. Currently, there are no approved treatments for NSTIs – the standard of care includes prompt and repeated surgical debridement, aggressive resuscitation and physiologic support, in addition to antibiotics.
The phase 3 ACCUTE (AB103 Clinical Composite endpoint StUdy in necrotizing soft Tissue infEctions) study is an ongoing randomized, placebo-controlled study, that plans to enroll 290 patients with NSTI at approximately 60 level 1 trauma sites in the U.S. Patients receive Reltecimod or placebo, administered as a single dose during or shortly after surgical debridement, in addition to standard of care treatment. The primary end point is a clinical composite that evaluates both the local and systemic components of this disease.
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies. This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400013C.
About Atox Bio
Atox Bio is a late stage clinical biotechnology company with operations in the US and Israel that develops novel immune modulators for critically ill patients with severe infections. Atox Bio is exploring the potential of Reltecimod in NSTI and additional critical care indications such as Acute Kidney Injury.
Atox Bio is supported by an investment syndicate including SR One, OrbiMed and Lundbeckfonden Ventures. Atox Bio was established by Prof. Raymond Kaempfer and Dr. Gila Arad from the Hebrew University of Jerusalem and Yissum.