Abivax has reported positive top-line data from the first cohort of Phase IIa ABX464-005 clinical trial of its drug candidate ABX464 in patients with HIV.
The results showed that ABX464 significantly decreased the HIV viral reservoir in blood, confirming the data obtained from the previous Phase IIa ABX464-004 trial.
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Based on the firm’s anti-viral platform, ABX464 is being developed to inhibit the HIV replication through a new mechanism that involves modulation of RNA biogenesis.
The trial’s first cohort included 11 patients administered with 150mg ABX464 for 28 days, along with their anti-retroviral therapy.
Analysis has been performed on blood samples and rectal biopsies collected at pre-specified time intervals to quantify changes in the viral reservoir and mucosal inflammation over time.
Of the total participants, two were reported to have discontinued the trial because of grade 1/2 adverse events, while eight of the remaining nine subjects demonstrated reduced HIV DNA in peripheral blood CD4+ T cells between day zero and day 28.
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By GlobalDataThe median decrease was found to be statistically significant, with patients showing a reduction from the initial 191 copies/million CD4+ T cells to 116 copies/million CD4 + T cells.
Abivax chief medical officer Dr Jean-Marc Steens said: “In this first cohort, the rectal biopsies did not yield enough HIV DNA to make an assessment of the viral reservoir.
“For the ongoing second cohort, we have made changes to the procedures to ensure that enough high-quality viral DNA is available for the generation of the appropriate data.”
The second cohort of the trial will involve evaluation of 50mg ABX464 over three months in 12 patients who are receiving their antiretroviral treatment.
It is expected that the initial results from this cohort will be available in the second quarter of next year.
