Abivax receives ANSM and Ethics Committee clearance to test its development candidate ABX464 in 1,034 Covid-19 patients in randomized Phase 2b/3 clinical trial
French regulator, ANSM, as well as Ethics Committee, CPP, have cleared ABX464 for Phase 2b/3 “miR-AGE” testing
The anti-inflammatory mechanism of action could prevent and treat cytokine storm and hyper-inflammation, which lead to acute respiratory distress syndrome (ARDS) and death of COVID-19 patients
New data[1] show ABX464 inhibits SARS-CoV-2 viral replication in vitro in a human respiratory epithelium model, making ABX464 a molecule with a potential triple action, antiviral, anti-inflammatory and tissue repair
50 French and European clinical trial sites to treat high-risk patients with complications early
Rigorous, randomized and placebo-controlled miR-AGE trial will include 1,034 patients with convenient oral administration
Discussions being finalized with Bpifrance and SGPI for ABX464 COVID-19 project grant funding
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PARIS, France, May 14, 2020 – 06:00 a.m. (CET) – Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announces today it has received clearance from France’s National Agency for the Safety of Medicines (ANSM) and French Ethics Committee (CPP) to initiate a randomized, double-blind, placebo-controlled Phase 2b/3 trial of ABX464 to prevent severe inflammation that leads to acute respiratory distress syndrome (ARDS) in 1,034 COVID-19 elderly or high-risk patients (miR-AGE trial).
Oral, once-daily ABX464 has demonstrated impressive efficacy in a Phase 2a trial in another severe inflammatory disease, ulcerative colitis, and its unique molecular mechanism of action supports the rationale to treat the cytokine storm and hyper-inflammation syndrome observed in COVID-19 patients. The hyper-inflammation in the lung is the primary cause of the respiratory distress and potential death of patients. ABX464 has been shown to upregulate miR-124[2],[3], a “physiological brake” of inflammation, and miR-124, a micro-RNA, down-regulates the multiple chemo- and cytokines involved in the COVID-19 cytokine storm, including TNF alpha, IL-1 beta, G-CSF, IL-6, MCP-1 and IL-17. In addition, unlike other potent anti-inflammatories that specifically target a single cytokine, ABX464 has not been associated with increased vulnerability to opportunistic infections.
Furthermore, new breakthrough data (see Abivax second press release) show that ABX464 inhibits replication of SARS-CoV-2 (COVID-19 virus) in an in vitro stringent human pulmonary epithelium model, making ABX464 the only drug candidate with the desirable triple action to treat COVID-19 patients: anti-inflammatory, antiviral and tissue repair, thanks to its overexpression of miR-124. In addition, convenient oral dosing (one capsule per day) allows for early treatment of hospitalized as well as non-hospitalized patients.
This rigorous Phase 2b/3 trial will be performed according to high international clinical standards at 50 hospitals in France and other European countries, following the past six weeks of already completed intense preparation. The study will include robust procedures for patient selection, randomization against placebo and study monitoring as well as data collection, management, and statistical analysis.
Key elements of the trial:
ABX464 oral dosing (50 mg once-daily) vs placebo and standard of care, 2 to 1 randomization
1,034 high-risk COVID-19 patients (older than 65 years or adults with risk factors)
Enrolling hospitalized and non-hospitalized patients with confirmed SARS-CoV-2 infection, recruitment is expected to be completed within a few months
Main evaluation criterion: absence of high-flow oxygen use or assisted ventilation or death within 28 days
Multiple clinical and biological secondary endpoints
Treatment (ABX464 or placebo and standard of care) duration: 28 days
50 French and European hospitals
This study will also address a number of crucial questions, notably ABX464’s ability to prevent the acute respiratory distress syndrome (ARDS) in elderly patients with or without risk factors, in younger patients with risk factors, and secondary impacts of a SARS-CoV-2 infection on pulmonary function. In times of crisis, treatment decisions are often based on small and sometimes not correctly controlled clinical trials. This rigorously conducted study is designed in a way to provide comprehensive clinical data on the safety and efficacy of ABX464 in COVID-19 patients.