Drugs

ABX464

ABX464

Drug Class: Rev Inhibitor Molecular Formula: C16 H10 Cl F3 N2 Registry Number: 1258453-75-6 (CAS) Chemical Name: 8-chloro-N-[4-(trifluoromethoxy)phenyl]quinolin-2-amine Organization: Abivax S.A. Phase of Development: ABX464 has completed Phase 2a testing and will begin Phase 2b development for HIV treatment in 2019.

(Compound details obtained from ChemIDplus Advanced,1 NIAID Therapeutics Database,2 ClinicalTrials.gov,3 and Abivax website4)

What is ABX464?

What is ABX464?

ABX464 is an investigational drug that is being studied to treat HIV infection.2

ABX464 belongs to a group of HIV drugs called Rev inhibitors.2 A Rev inhibitor interferes with the activity of an HIV protein called Rev. This prevents HIV from multiplying and can reduce the amount of HIV in the body.5

Research suggests that ABX464 may help people with HIV control their viral loads for long periods of time and may help reduce or eliminate the latent HIV reservoir in the body.6,7

To learn about how investigational drugs are tested during clinical trials, read the AIDSinfo What is an Investigational HIV Drug? and HIV/AIDS Clinical Trials fact sheets.

Which clinical trials are studying ABX464?

Which clinical trials are studying ABX464?

Study Names: ABX464-003; NCT02452242
Phase: 2a
Status: This study has been completed.
Location: Mauritius and Thailand
Purpose: The purpose of this study was to evaluate the safety, effectiveness, and pharmacokinetics of ABX464.8,9

Study Names: ABX464-004; NCT02735863
Phase: 2a
Status: This study has been completed.
Location: Belgium, France, and Spain
Purpose: The purpose of this study was to evaluate the safety of two different doses (50 mg and 150 mg) of ABX464. The study also examined the effect of ABX464 on the latent HIV reservoir and on viral load levels during a structured treatment interruption of antiretroviral therapy.3,7

Study Names: ABX464-005; NCT02990325
Phase: 1/2
Status: This study has been completed.
Location: Spain
Purpose: The purpose of this study was to evaluate the safety of ABX464. The study also examined the pharmacokinetics of ABX464 and the drug's effects on the body.10

For more details on the studies listed above, see the Health Professional version of this drug summary.

What side effects might ABX464 cause?

What side effects might ABX464 cause?

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of ABX464 listed above.

ABX464-003 (NCT02452242):
In this study, the majority of participants who received ABX464 experienced side effects, but none of the side effects were serious, and no one quit the study because of a side effect. The most common side effects related to ABX464 were headache, nausea, and vomiting. Other side effects experienced by participants who received ABX464 included upper abdominal pain and skin rash.8

ABX464-004 (NCT02735863):
In this study, there were no drug-related side effects among the participants who received the 50-mg dose of ABX464. However, eight of the participants who received the 150-mg dose of ABX464 had a drug-related side effect. Among those who received the 150-mg dose of ABX464, one participant had severe fatigue, and another participant quit the study early because of abdominal pain that was not related to ABX464.11

Because ABX464 is still being studied, information on possible side effects of the drug is not complete. As testing of ABX464 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying ABX464?

Where can I get more information about clinical trials studying ABX464?

More information about ABX464-related research studies is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.

Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Trials and You.

References

References

  1. United States National Library of Medicine. ChemIDplus Advanced: ABX-464. https://chem.nlm.nih.gov/chemidplus/rn/1258453-75-6. Accessed August 16, 2019
  2. National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Accessed August 16, 2019
  3. Abivax S.A. A multi-center, randomized, double-blind, placebo-controlled Phase IIa trial to compare the safety of ABX464 given at a fixed dose to placebo in fully controlled HIV infected patients treated with boosted protease inhibitor treatment (darunavir/ritonavir or darunavir/cobicistat). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on April 8, 2016. NLM Identifier: NCT02735863. https://clinicaltrials.gov/ct2/show/NCT02735863. Accessed August 16, 2019
  4. Abivax. Pipeline. http://www.abivax.com/pipeline/. Accessed August 16, 2019
  5. Hope TJ, Trono D. Structure, expression, and regulation of the HIV genome. In: Coffey S, Volberding P, eds. HIV InSite Knowledge Base. University of California San Francisco; 2000. http://hivinsite.ucsf.edu/InSite?page=kb-02-01-02#S2.2.2X. Accessed August 16, 2019
  6. Abivax. ABX464 for HIV. http://www.abivax.com/pipeline/abx464-hiv/. Accessed August 16, 2019
  7. Paredes R, Vandekerckhove L, Clotet B, et al. ABX464 decreases total HIV DNA in PBMCs when administered during 28 days to HIV-infected virologically suppressed patients. Poster presented at: International AIDS Society (IAS) Conference on HIV Science; Paris, France; July 23-26, 2017. Poster TULBPEB22. http://programme.ias2017.org//PAGMaterial/eposters/5650.pdf. Accessed August 16, 2019
  8. Steens J-M, Scherrer D, Gineste P, et al. Safety, pharmacokinetics, and antiviral activity of a novel HIV antiviral, ABX464, in treatment-naive HIV-infected subjects in a Phase 2 randomized, controlled study. Antimicrob Agents Chemother. 2017;61(7):e00545-17.
  9. Abivax S.A. A Phase 2, dose escalation, schedule comparison study to evaluate the safety, pharmacokinetics, and viral kinetics of ABX464 in untreated patients with HIV infection in Mauritius. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on April 10, 2015. NLM Identifier: NCT02452242. https://clinicaltrials.gov/ct2/show/NCT02452242. Accessed August 16, 2019
  10. Abivax S.A. An open-label study of the safety, pharmacokinetics, and pharmacodynamics of ABX464 in HIV-1 seronegative and seropositive adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on December 7, 2016. NLM Identifier: NCT02990325. https://clinicaltrials.gov/ct2/show/NCT02990325. Accessed August 16, 2019
  11. Rutsaert S, Steens J-M, Gineste P, et al. Safety, tolerability and impact on viral reservoirs of the addition to antiretroviral therapy of ABX464, an investigational antiviral drug, in individuals living with HIV-1: a Phase IIa randomised controlled study. J Virus Erad. 5(1):10-22.

Last Reviewed: August 16, 2019

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