Abivax starts second phase IIa trial of ABX464 in HIV/AIDS patients

The patient will be treated at University Hospital Germans Trias i Pujol in Badalona, Barcelona, Spain.

Abivax will undertake the trial at clinical centers in Spain and Belgium, where it secured all regulatory and ethics committees authorizations, and in France where pending ethics committees approvals are anticipated imminently.

The second phase IIa trial will demonstrate the long-lasting effect of ABX464 that was observed in preclinical studies.

About 28 patients will be enrolled in the study whose HIV infection is already fully controlled by boosted Darunavir.

ABX464 will be administered to 21 patients in combination with their existing drug regimen, while the remaining seven subjects will be given placebo in combination with their current therapy.

All treatment will be discontinued after 28 days 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 time to rebound of the viral load the study’s efficacy endpoint. The rebound will start from the HIV reservoirs, which are not affected by existing combination antiretroviral treatment.

Preliminary results of the trial are anticipated in the fourth quarter of this year.

Abivax CEO Hartmut Ehrlich said: "This Phase IIa clinical trial is designed to test the promising preclinical data observed in an animal model, which showed evidence of long lasting control of viral load following cessation of ABX464 treatment.

"If confirmed in HIV patients in this study, such a long-lasting effect would differentiate ABX464 from all existing HIV therapies."