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Abivax: its drug candidate declared "national research priority" for its fight against Covid-19

Institut Curie
01/05/2021
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Abivax, a biotech resulting from the collaboration between Institut Curie and the IGMM, has announced that the French government has granted "national research priority" status to the clinical trial of its drug candidate ABX464 to prevent inflammation in patients with Covid-19.
Abivax

Abivax, a biotech resulting from the collaboration between Institut Curie and Institut de Génétique Moléculaire de Montpellier (IGMM), announced on December 22, 2020, that it has obtained the status of "national research priority" for the clinical trial (miR-AGE) of its molecule ABX464 aimed at preventing inflammation in patients suffering from Covid-19, issued by the French government's steering committee for therapeutic trials. Abivax is a clinical stage biopharmaceutical company that leverages its multiple drug development platforms to treat patients with inflammatory diseases, viral infections and cancer.

ABX464: lead molecule from Institut Curie

Institut Curie is associated with this major and promising breakthrough since Abivax - initially named Splicos - was founded on results obtained during screening of Institut Curie's chemical library, from which the ABX464 molecule was derived. Managed by Florence Mahuteau-Betzer, this collection of small molecules contains more than 10,000 substances for high-throughput testing of drug candidates.

This breakthrough by a company whose main product is the result of the work of Institut Curie’s researchers demonstrates the importance of the valorization of research for companies (Technology Transfer) to strengthen the therapeutic arsenal. Since its creation in 2009, Abivax (formerly Splicos) has been developing products under license from Institut Curie, CNRS and the University of Montpellier, based on a portfolio of more than 20 patents, and is developing its projects through several R&D contracts at Institut Curie site in Orsay

said Amaury Martin, PhD, head of Technology Transfer Office and Carnot Curie Cancer.

A glimmer of hope for the fight against Covid-19

In clinical and preclinical trials, Abivax' lead drug candidate, ABX464, demonstrated a particularly innovative triple effect against Covid-19, as Florence Mahuteau-Betzer explains:

The Abivax molecule has a novel triple action linked to an antiviral, anti-inflammatory and tissue repair effect. This could prove highly beneficial in treating high-risk and elderly patients with Covid-19.

In addition, with its unique mechanism of action (increased expression of a specific microRNA; miR-124) and easy oral administration, ABX464 has the potential to prevent and treat "cytokine storm" and hyper-inflammation leading to acute respiratory distress syndrome (ARDS) and death in Covid-19 patients.

The trial is now in phase 2b1/32, and has been declared a "national research priority" by the ad-hoc National Steering Committee for Therapeutic Trials and Other Research (CAPNET). This committee, advised by the REACTing scientific council, was created by the French government to identify the most promising and high-impact Covid-19 clinical studies. The aim is to help investigators focus their recruitment efforts on these priority studies and to make the first results available as soon as possible.

Should the results of the phase 2b/3 study of ABX464 in Covid-19, expected in the second quarter of 2021, be positive, Abivax will immediately seek approval for commercialization in the main geographical areas in 2021, while preparing the scale-up of industrial production and the potential commercialization of ABX464.

The oral administration of the drug candidate is particularly advantageous as it could potentially avoid hospitalizations and relieve the pressure on healthcare systems. Another advantage is that the mechanism of action of ABX464 is not expected to be impacted by possible mutations in the virus.

 

ABX464, Abivax's most advanced compound, has already demonstrated its ability to reduce viral reservoirs in HIV patients by completing two phase 2a1 clinical trials. To date, ABX464 is in clinical development in a phase 2b trial in ulcerative colitis (UC), a Phase 2a trial in rheumatoid arthritis (RA), and a pivotal phase 2b/3 trial in Crohn's disease is in preparation.

 

 

1. Phase 2: divided into two phases, phase 2a studying the dosage of the treatment and phase 2b evaluating its efficacy. It is conducted on a limited number (100 to 200) of patients.

2. Phase 3: comparative efficacy study phase, also known as a "pivotal study". In the event of a positive result, it leads to a marketing authorization application.