Ness Ziona, Israel – June 15, 2016 - Atox Bio, a clinical stage company developing novel immunemodulators for critically ill patient with severe infections, today announced that it has been awarded the next option on a performance-based contract with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of AB103 in patients with Necrotizing Soft Tissue Infections (NSTI).
The award of this upsized option brings the current commitment from BARDA to $17.4 million. The value of the increased contract in total is approximately $29 million if all options are exercised. The contract covers the pivotal phase 3 study of AB103, manufacturing and regulatory activities. The contract, initiated in 2014, runs through 2018.
Dan Teleman, CEO of Atox Bio, stated, “We appreciate BARDA’s recognition of the progress made in the development of AB103 during this key period and the importance of developing a novel, host-based therapy to treat severe infections. We have enjoyed a very productive collaboration and look forward to continuing to work with BARDA.”
About AB103
AB103 is a rationally designed peptide binding to the CD28 co-stimulatory receptor that modulates the host’s immune response. By modulating, but not inhibiting, the immune response, AB103 acts to significantly dampen the ‘out-of-control’ acute inflammatory response that leads to tissue and organ damage.
AB103 is currently being evaluated in the phase 3 ACCUTE (AB103 Clinical Composite endpoint StUdy in necrotizing soft Tissue InfEctions) study. ACCUTE is an ongoing randomized, placebo-controlled study, that plans to enroll 290 patients with NSTI at approximately 60 centers in the U.S. Patients are receiving AB103 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.
Atox Bio is exploring the potential for AB103 in NSTI and additional critical care indications such as Acute Kidney Injury. AB103 has received Orphan Drug status from the FDA and EMA as well as Fast Track designation.
About Atox Bio
Established by Prof. Raymond Kaempfer and Dr. Gila Arad from the Hebrew University of Jerusalem and Yissum, Atox Bio is a clinical stage biotechnology company with operations in Israel and the U.S. that develops novel immune modulators for critically ill patients with severe infections. Atox Bio is supported by an investment syndicate consisting of SR One, OrbiMed and Lundbeckfond Ventures.
