Ongoing Clinical Development of ABX464: ABIVAX Launches ABX464-004 Study First p

[gorka]

ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), an emerging leader in developing and commercializing anti-viral therapies and immunotherapeutics for infectious diseases like HIV/AIDS and chronic hepatitis B (CHB), today announced that the first patient in the ABX464-004 study has been enrolled, effectively launching the second Phase IIa trial in HIV/AIDS patients with drug candidate ABX464. The first patient treatment in this trial is scheduled to take place at University Hospital Germans Trias i Pujol in Badalona, Barcelona, Spain. The trial will be conducted at clinical centers in Spain and Belgium, where all regulatory and ethics committees authorizations have been received, and in France where pending ethics committees approvals are expected imminently.

Prof. Bonaventura Clotet, Director of the IrsiCaixa AIDS Research Institute at the University Hospital Germans Trias i Pujol in Barcelona, Spain commented: “We are very excited to enroll the first patient into this important clinical trial. The outcome of this study aims to provide a proof of concept that ABX464 could potentially be part of a functional cure for HIV.”

Study ABX464-004, the second Phase IIa trial conducted with ABX464, is designed to demonstrate the long-lasting effect of ABX464, which has been observed in preclinical studies. The study will enroll twenty-eight patients whose HIV infection is already fully controlled by boosted Darunavir. ABX464 will be administered to 21 of these patients in combination with their current drug regimen, while the remaining 7 patients will be given placebo in combination with their current therapy. After 28 days, all treatment will be discontinued and the study will then measure the time elapsed until the HIV virus reappears in the blood of the ABX464-treated patients and the control group. The efficacy endpoint of the study is the time to rebound of the viral load. This rebound will originate from the HIV reservoirs, which are not affected by current combination antiretroviral treatment. Preliminary results of this study are expected in Q4 2016.

http://www.businesswire.com/news/home/20160530005192/en/Ongoing-Clinical-Development-ABX464-ABIVAX-Launches-ABX464-004