Abivax Phase 2a HIV med data ‘mixed’

• Paris-based Abivax announced topline results from the second cohort of its Phase 2a study of ABX464 in patients with HIV, with mixed findings.
• Twelve patients were given a dose of 50 mg per day of ABX464 for three months. From the available data at 12 weeks, eight patients had completed the study.
• Four patients showed a reduction in total HIV DNA in peripheral blood CD4+ T cells, ranging from 2% to 85%, while the other four patients experienced an increase in HIV DNA, ranging from 5% to 36%.

The treatment aims to reduce the reservoirs of infected immune cells that can lay dormant in a patient’s blood, brain, gut and lymph nodes even after viral load has been reduced to undetectable levels by other regimens.

In the first cohort of the study, which included nine patients given 150 mg per day of ABX 464 for 28 days, eight patients showed a decrease in HIV DNA in peripheral blood CD4+ T cells up to 52%.

The second cohort was designed to see if a lower dose of the drug could also decrease levels — so far the results are mixed — and to see if the drug could be tolerated for a longer period of time. Abivax did not release any safety data, but said the drug was well-tolerated.

Rectal tissue biopsies were also conducted, with four patients showing a reduction in HIV DNA ranging from 16% to 71%, and four patients showing an increase in HIV DNA from 14% to 123%.

Abivax intends to present the full data at an upcoming medical meeting.

“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,” said Ian McGowan, a professor at the University of Pittsburgh School of Medicine and chair of Abivax’s Scientific Advisory Board, in a statement.

Shares of Abivax were up nearly 7% on the news in trading on the Euronext Paris stock exchange.

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