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 is in Phase IIa development for HIV treatment.

(Compound details obtained from ChemIDplus Advanced,1 NIAID Therapeutics Database,2 and ClinicalTrials.gov3)

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 Rev is an HIV protein that helps to transport HIV’s genetic information within an infected immune cell. The Rev protein is essential for HIV to replicate and produce new virus.4 By interfering with the activity of the Rev protein, Rev inhibitors prevent HIV from multiplying and may reduce the amount of HIV in the body.5

Researchers suggest that ABX464 may also help a person’s own immune system to recognize and reduce or eliminate latent HIV reservoirs in the body.5,6 A latent HIV reservoir is a group of immune cells in the body that are infected with HIV but are not actively producing new HIV. Because current HIV medicines do not work against HIV that's hidden in latent reservoirs, these reservoirs are one of the main obstacles to curing HIV infection.

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: IIa
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 ABX464.7,8

Study Names: ABX464-004; NCT02735863
Phase: IIa
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 latent HIV reservoirs and on viral load levels during a treatment interruption.3,6

Study Names: ABX464-005; NCT02990325
Phase: I/II
Status: This study is currently recruiting participants.
Location: Spain
Purpose: The purpose of this study is to evaluate the safety of ABX464. The study will also examine the pharmacokinetics of ABX464 and the drug’s effects on the body.9

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 receiving ABX464 reported a side effect, 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 on ABX464 included upper abdominal pain and skin rash.7

ABX464-004 (NCT02735863):
In this study, there were no drug-related side effects among the participants receiving the 50-mg doseof ABX464. However, 8 of the participants receiving the 150-mg dose of ABX464 had a drug-related side effect, most often moderate abdominal pain and headache. Among those receiving the 150-mg dose of ABX464, 1 participant had severe fatigue related to ABX464 treatment, and another participant quit the study early because of ABX464-related moderate abdominal pain and mild epigastric pain.3,6,10

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 information, visit NIH Clinical Trials and You.

References

References

  1. United States National Library of Medicine. ChemIDplus Advanced: ABX464. https://chem.nlm.nih.gov/chemidplus/rn/1258453-75-6. Accessed October 11, 2018.
  2. National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Accessed October 11, 2018.
  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 October 11, 2018.
  4. 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 October 11, 2018.
  5. Abivax website. ABX464/HIV. http://www.abivax.com/en/development-products/abx464.html. Accessed October 11, 2018.
  6. 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 October 11, 2018.
  7. 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). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5487684/. Accessed October 11, 2018.
  8. 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 October 11, 2018.
  9. 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 October 11, 2018.
  10. Vandekerckhove L, Paredes R, Clotet B, et al. ABX464 decreases total HIV DNA and integrated HIV DNA in PBMCs when administered during 28 days to HIV-infected virologically suppressed patients. http://www.natap.org/2017/EACS/EACS_35.htm. Accessed October 11, 2018.

Last Reviewed: October 11, 2018