Atox Bio’s co-founders elucidated the role of the CD28 dimer interface as a novel therapeutic target in the co-stimulatory process. Defining this functional domain allowed the company to target the critical co-stimulatory pathway in a completely new way and modulate multiple components of the inflammatory response using rationally designed short peptides, 8 to 12 amino acids in length. Modulating, but not inhibiting, the co-stimulatory response significantly improves the host’s ability to effectively fight the infection. It also reduces the tissue damage caused to key organs during acute inflammatory situation such as severe infections or ischemia/reperfusion injuries as well as in chronic inflammatory diseases. Atox Bio is implementing this novel mode of action into a unique approach to treating infectious diseases by targeting the host immune system, rather than the pathogen, thereby providing solution for bacterial infections with broad-spectrum coverage, independent of pathogen type and eliminating the risk of drug resistance. The peptides provide protection from superantigen toxins and lethal bacterial infections in experimental models of a wide range of bacterial pathogens (gram positive, gram negative and polymicrobial infections), and block symptoms of disease in models of inflammatory/autoimmune diseases. The uniqueness of Atox Bio's technology is in attenuating multiple pathways responsible for the deregulated inflammatory response, commonly the cause of pathology and organ failure in infectious and inflammatory diseases.
AB103: Lead product
This unique technology generated AB103, Atox Bio’s lead product. Under an IND approved in June 2010, AB103 has successfully completed a phase 1 clinical study. The phase 1 was a double blind, placebo controlled, study that included 25 healthy volunteers receiving escalating single doses of AB103. The study was conducted at the University of Maryland in Baltimore, US. AB103 was safe and well tolerated without any significant drug-related adverse events. The clinical indications for which AB103 is initially being developed include (i) necrotizing soft tissue infections (NSTI) for which it has received an Orphan Drug Designation from the FDA in October 2011 and (ii) severe intra-abdominal infections. A phase 2 study was initiated in Decenber 2011. The phase 2 evaluates AB103 in up to 56 patients with NSTI. Patients receive one of two doses of AB103 in addition to standard of care. The study is conducted at 7 leading surgical trauma centers in the US.