ABX464 for HIV

Functional Cure

ABX464 is an oral, first-in-class, small molecule inhibiting HIV replication through an entirely new mechanism of action, and has completed two Phase 2a clinical trials.

The HIV virus works by infecting immune cells and incorporating instructions for cellular production of new viruses into the cells’ DNA. Antiretroviral-based therapy works by keeping active viruses produced by infected cells out of the blood stream, but this form of treatment is incapable of addressing the root of viral infection within infected cells. With these viral “factories” still in operation, viral rebound can occur if treatment is missed.

For the first time in the treatment of HIV, this molecule could reduce or eliminate the viral reservoirs, and thus potentially deliver a long-lasting reduction in the viral load of HIV-patients.


Long-term Control

ABX464 is the first HIV antiviral that, in transgenic, humanized mice, induced a long-term control of the viral load after treatment arrest.

In two Phase 2a clinical trials, ABX464-004 and ABX464-005, ABX464 demonstrated up to 50% reduction of HIV-DNA in peripheral blood mononuclear cells after 28 days of combination treatment with anti-retroviral therapy.

This unique mode of action and the preclinical data to-date suggest that ABX464 has the potential to:

  • Reduce or eliminate the viral reservoirs in patients with HIV;
  • Induce long term control of the viral load;
  • Prevent the emergence of HIV mutants that are resistant to treatment after six months of treatment in vitro;
  • Be less frequently administered.

In the Clinic

Abivax has released results from ABX464-005, a phase 2a study in HIV infected patients that measured whether ABX464 could reduce the HIV reservoir in blood and in rectal tissue of these fully suppressed HIV patients. ABX464-005 showed that ABX464 reduced HIV-viral reservoirs in the blood as well as in rectal tissue.

Next Steps

In HIV, Abivax continues its clinical development with ABX464 through investigator-initiated trials, conducted independently at clinical research institutes with Abivax to provide the test medication for these studies.