ABIVAX Successfully Completes First-in-Man Study of Small Molecule Targeting HIV

ABIVAX recently announced the successful completion of its Phase I first-in-man study of ABX464, which has been designed to potentially deliver a number of important clinical benefits when treating patients with HIV.

AXB464 is a novel, small molecule with the potential to inhibit HIV replication. Through its unique mode of action, ABX464 is the first anti-HIV drug able to induce a long-lasting HIV viral load reduction even after treatment has been stopped, in pre-clinical testing in mice. ABX464 has also shown an absence of resistance in vitro.

ABX464 is the first candidate molecule coming from ABIVAX’s proprietary technology platform and chemical library, generated from its deep understanding of the processing of viral RNA within the human host cell and the ability of compounds from its novel library to inhibit RNA-protein interactions. This platform allows ABIVAX to potentially address a broad range of viral targets.

The successful first-in-man trial of ABX464 in healthy volunteers assessed pharmacokinetic properties and biological safety. The Phase I study was completed with single administration of 4 doses: 50, 100, 150 and 200 mg, and saw no serious adverse event and no clinically significant abnormal result in physical examinations, laboratory test results, vital signs, and ECG.

ABIVAX plans to start a Phase II study in patients with HIV in the coming months.
Prof. Hartmut Ehrlich, MD, CEO of ABIVAX, said “We are very pleased with the results of the first-in-man study of ABX464. ABX464 is one of our flagship products currently under development and these results pave the way for the upcoming launch of our Phase 2 study. We are confident that ABX464, with its unique properties and mode of action, has the potential to induce a long-lasting control of the virus for the benefit of the more than 35 million people worldwide living with HIV.”

ABIVAX is a leading clinical-stage biotech company focused on becoming a global leader in the discovery, development, and commercialization of anti-viral compounds and human vaccines to treat some of the world’s most important infectious diseases, including HIV/AIDS and Hepatitis B. ABIVAX has 2 compounds in clinical stage research: ABX464 a novel small molecule against HIV with a number of important potential competitive advantages, and ABX203, a therapeutic vaccine candidate that could be a cure for chronic hepatitis B. The broader ABIVAX portfolio includes additional anti-viral compounds and vaccines that may enter the clinical stage in the coming 12-18 months. ABX464 has been developed using ABIVAX’s anti-viral platform that allows the company to address a broad range of viral targets. ABIVAX has access to a number of cutting-edge technologies, including RNA-protein interaction Interference, B cell and cytotoxic TH1 cell amplification which it is using to generate proprietary breakthrough therapies to help patients clear important pathogenic viruses.

Headquartered in Paris, France, ABIVAX conducts its research and development in Évry (France) and Montpellier (France). In addition, ABIVAX benefits from long term partnerships with the Cuban Center for Genetic Engineering and Biotechnology (Havana, Cuba), The Finlay Institute (Havana, Cuba), the British Columbia Cancer Agency (Vancouver, Canada), the CNRS (Montpellier, France), the Scripps Research Institute (La Jolla, CA, USA), the University of Chicago (Chicago, IL, USA), Brigham Young University (Provo, UT, USA) and the Institut Pasteur (Paris, France). ABIVAX intends to pursue further business development opportunities to access commercial products as part of its overall corporate strategy. For more information, visit www.abivax.com.