Date: 2011-05-12
Type of information: Initiation of preclinical development
phase: 1
Announcement: completion of the study
Company: Atox Bio (Israel)
Product: AB103
Action
mechanism: AB103 is a rationally designed short peptide acting as a CD28 modulator regulating the host’s inflammatory response.
Disease:
Therapeutic area: Infectious diseases
Country: USA
Trial
details: 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.
Latest
news: Atox Bio has announced that it successfully completed a phase 1 clinical study of AB103, a novel therapy for the treatment of severe bacterial infections and sepsis. 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.
The phase 1 was supported by a grant from the Israel-U.S. Binational Industrial Research and Development (BIRD) foundation
