AB103: Lead Product:
This unique technology generated AB103, Atox Bio’s lead product, which has both anti infective and tissue protective activities. 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 has been initiated on December 2011. The phase 2 will evaluate AB103 in up to 56 patients with NSTI. Patients will receive one of two doses of AB103 in addition to standard of care. The study will be conducted at 7 leading surgical trauma centers in the US.
Pre clinical experience:
In pre-clinical models, IV administration of AB103 demonstrated significant protection, rescuing 80-100% of mice from both gram-negative and gram-positive lethal bacterial infections, including necrotizing soft tissues infections, peritonitis, pneumonia and bacteremia.
AB103 was effective either alone or in combination with antibiotics demonstrating a strong synergistic effect, improving overall survival and extending the therapeutic window for administering antibiotics.
AB103 has been also shown to significantly increase survival when administrated in combination with Tamiflu in animals following viral infections of H1N1 (swine flu) and H5N1 (bird flu).