Product Development Portfolio

Inflammation

  • Ulcerative Colitis Anti-inflammatory
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
    ABX464 Phase 2a complete; Phase 2b ongoing

    Description/Summary:

    ABX464 is an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory activity in preclinical trials and in a Phase 2a clinical trial, ABX464-101, to treat ulcerative colitis (UC). Patients who completed the induction study had the option to roll over into a 12-month open-label extension study, ABX464-102, in which 22 out of 23 eligible patients were enrolled.

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    Milestones:

    • Phase 2a data from maintenance study reported in H2 2019
    • Phase 2b trial ongoing
  • Crohn’s Disease Anti-inflammatory
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
    ABX464 Phase 2b/3 pivotal study in preparation

    Description/Summary:

    ABX464 is an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory efficacy in a completed Phase 2a induction study as well as a 24-month maintenance study in patients with moderate-to-severe ulcerative colitis (UC).
    Due the clinical similarities of Crohn’s disease (CD) and UC, and the predictability of the DSS model for both UC and CD, several key opinion leaders (KOLs) are confident that ABX464 will also show beneficial effects in patients suffering from CD.

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  • Rheumatoid Arthritis Anti-inflammatory
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
    ABX464 Phase 2a ongoing

    Description/Summary:

    ABX464 is an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory activity in a completed Phase 2a induction study as well as a 12-month maintenance study in patients with moderate-to-severe ulcerative colitis (UC). In addition to the clinical observations in UC patients, Abivax generated promising pre-clinical data from collagen-induced arthritis animal models.

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    Milestones:

    • Phase 2a study ongoing

Inflammation and Antiviral

  • COVID-19 Antiviral and Anti-inflammatory
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
    ABX464 Phase 2b/3 ongoing

    Description/Summary:

    ABX464 is an oral, first-in-class, small molecule that has been shown to inhibit the replication of the HIV virus and to have a sustainable anti-inflammatory effect in patients suffering from ulcerative colitis along with tissue repair properties. In addition, new in vitro data also have shown the ability of ABX464 to inhibit the replication of SARS-CoV-2 (COVID-19). With a potential triple effect that includes 1) inhibition of the SARS-CoV-2 virus replication, 2) prevention and treatment of the acute respiratory distress syndrome (ARDS) caused by hyperinflammation, as well as 3) limit longer-term pulmonary dysfunction due to resulting tissue damage in the lungs, ABX464 could be a promising candidate for the treatment of the COVID-19 disease, especially in its severe form. Therefore, a Phase 2b/3 study with ABX464 in 1,034 patients with COVID-19 is being conducted in Europe and Latin America to assess whether the drug candidate can prevent the cytokine storm and ARDS in these patients.

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    Milestones:

    • New preclinical data shows ABX464 ability to inhibit SARS-CoV-2 viral replication in human lung tissue
    • Regulatory approval received in France and Germany for a Phase 2b/3 trial in 1,034 patients

Antiviral

  • HIV Lasting viral remission
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
    ABX464 Phase 2a complete; investigator-initiated trials

    Description/Summary:

    ABX464 is an oral, first-in-class, novel, small molecule inhibiting HIV replication through an entirely new mechanism of action. 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 virological suppression in HIV-patients.

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    Milestones:

    • Phase 2a data delivered in H1 2018
    • Continued clinical development through investigator-initiated trials
  • Respiratory Syncytial Virus Antiviral drug
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
  • Dengue Antiviral drug
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
  • Influenza Antiviral drug
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3

Cancer

  • Hepatocellular Cancer Immune Enhancer
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
    ABX196 in Phase 1/2 POC clinical trial in HCC ongoing

    Description/Summary:

    ABX196 has been developed as a synthetic agonist of iNKT cells from a proprietary platform technology that identifies cells with immune enhancing potential in cancer models.

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    Milestones:

    • Phase 1/2 trial ongoing