Abivax’s Phase II study of HIV drug, ABX464, produces mixed data

Abivax (paris, France) have unveiled top-line results from their Phase IIa ABX464-005 study, demonstrating the new treatment ABX464 reduced HIV DNA levels in blood and rectal tissues in patients with a HIV infection at a 150mg/day dose.

The trail was conducted at the Hospital Germans Trias i Pujol (Barcelona, Spain) and was composed of two cohorts. In the first intake, nine patients were treated with 150mg of ABX464 per day for 28 days, with eight of these patients demonstrating a decrease in HIV DNA in peripheral blood CD4+ T cells (up to 52%).

The second cohort examined 12 patients, who were given a smaller ABX464 dose (50mg/day) for 3 months in order to evaluate the potential of this lower dose to eliminate the HIV reservoir. The researchers observed from week 12 data (comprising eight patients) four individuals had a reduction in total HIV DNA in peripheral blood CD4+ T cells, ranging from 2–85%, and four patients experienced an increase in HIV DNA between 5% and 36%.

In rectal biopsies the data were similar, with four patients experiencing a reduction in HIV DNA (16–71%) and four patients experiencing an increase (14–23%).

Ian McGowan, Professor at the University of Pittsburgh (PA, USA) and Chair of ABIVAX’s Scientific Advisory Board, commented: “The study results demonstrate that some HIV-infected patients receiving 50mg of ABX464 had a relevant drop in the HIV DNA reservoir. Further studies will identify the characteristics of the patients most likely to benefit from ABX464 in different dosing regimens, alone or in combination with other HIV cure strategies.”

Abivax noted that a Phase IIb trial is currently planned.

Jean-Marc Steens, Chief Medical Officer at ABIVAX, concluded: “These findings show, for the first time, that ABX464 has the ability to reduce HIV DNA in both blood and rectal tissue reservoirs. The longer 12 week duration of treatment with ABX464 was safe and generally well tolerated and supports extended dosing. ”

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Source: www.abivax.com/en/news-events/press-releases/656-abivax-releases-positive-top-line-data-from-abx464-005-phase-2a-study-in-hiv-infection.html


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