NESS ZIONA, Israel--(BUSINESS WIRE)-- 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".
AB103, a novel immunomodulator, offers a unique approach in the treatment of infectious diseases by modulating but not inhibiting the host immune system. This approach of targeting the host immune response rather than the pathogen precludes the rapid generation of drug resistance and provides a multisystem solution for bacterial infections with broad-spectrum coverage, independent of pathogen type.
The phase 1 was supported by a grant from the Israel-U.S. Binational Industrial Research and Development (BIRD) foundation.
About Atox Bio
Established in 2003 by Prof. Raymond Kaempfer, Dr. Gila Arad from the faculty of Medicine and Yissum, the technology transfer company of the Hebrew University of Jerusalem, Atox Bio is a clinical stage biotechnology company that develops peptides and small molecules therapeutics for diseases mediated by an excessive inflammatory response.
Atox Bio focuses on novel modulators that act broadly to attenuate excessive cytokine responses, with therapeutic applications ranging from infectious to inflammatory/autoimmune diseases. These applications represent areas with major unmet medical need.
For more information, please visit http://www.atoxbio.com
Dan Teleman - CEO
E-mail: [email protected]
KEYWORDS: United States North America Maryland Middle East Israel
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Pharmaceutical Research Science