French biotechnology firm Abivax has reported positive preliminary results from the Phase IIa ABX464-004 clinical trial of ABX464 to treat patients infected with HIV.
ABX464 is a first-in-class, small molecule therapeutic candidate currently being developed to prevent HIV replication.
The results showed that the product has reduced HIV reservoirs as measured by total HIV DNA found in peripheral blood mononuclear cells (PBMCs).
The ABX464-004 trial evaluated ABX464 over a period of 28 days in patients who were already receiving anti-retroviral treatment.
The trial's primary endpoint was safety and included 30 patients recruited in Spain, Belgium and France.
Abivax chief medical officer Jean-Marc Steens said: "In this Phase IIa clinical trial, during which patients were treated only for a short period of 28 days, we did not yet see an impact on the time to rebound after treatment interruption.
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"Therefore, the next step will be to evaluate longer treatment duration with ABX464, which could lead to a profound reduction of the HIV reservoir and potentially become part of a functional cure for HIV patients.”
At the beginning of the trial, viral load was controlled with boosted darunavir and the treatment was discontinued after 28 days until viral load rebound.
The potential effect of ABX464 on HIV reservoir was assessed using baseline and blood samples from day 28.
ABX464 was found to be well tolerated without severe adverse events.
The effect of ABX464 on HIV reservoirs in gut tissues is being investigated in another Phase IIa trial, ABX464-005.
Based on the ABX464-004 results, the firm intends to extend the treatment period of ABX464-005 in order to study the longer-term effects that ABX464 might have on HIV reservoir suppression.
The initial results from the ABX464-005 trial are estimated to be reported in the third quarter of this year.