Atox Bio Inc. today announced that it successfully completed a phase 1 clinical study of AB103, a novel therapy for the treatment of severe bacterial infections and sepsis.
The trial was designed to evaluate the safety, tolerability and pharmacokinetics of AB103. It 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. Ex vivo analysis has demonstrated that AB103 does not alter the normal immune response. PK analysis indicated a dose proportional response in all kinetic parameters.
"This is a major milestone for Atox Bio and we look forward to continuing the development of AB103" stated Dan Teleman, Atox Bio's CEO. "Atox Bio is now working diligently to initiate a phase 2 proof of concept study in necrotizing soft tissue infections, a severe and life threading infection".
Alan S. Cross, M.D., Professor of Medicine at University of Maryland in Baltimore, Center for Vaccine Development, and the study's Principal Investigator stated that "AB103was extremely well tolerated by the subjects at every dose tested. The subject could not tell when the drug was being infused".
Half of sepsis patients face death within two years