The funding led by by BPI France consists of a €20.1m grant and €15.9m loan refundable upon success of the company’s miR-AGE Phase II/III clinical trial with ABX464 in high-risk patients with COVID-19, which Abivax expects to start soon. Additionally, Abivax will use the cash injection for manufacturing scale-up and additional development costs related to the potential filing of ABX464 Marketing Authorisation Applications
ABX464 is an orally dosed immunesuppressive antiviral upregulating a microRNA, miR-124, that has shown antiviral, anti-inflammatory and tissue repair properties. With its triple effect, hopes to limit replication of SARS-CoV-2 virus, prevent and treat the cytokine storm, hyper-inflammation, and acute respiratory failure syndrome in later COVID-19 disease stages. ABX464 produced mixed results in a Phase IIa clinical trial in patients with HIV, the viral infection, which produced the most deaths so far.
“Our goal is to now implement the 1,034 patients ABX464 miR-AGE trial as rapidly as possible and, if we get positive results, bring with no delay ABX464 to the market and manufacture sufficient drug product for patients”, said Philippe Pouletty, founder and Chairman of Abivax and CEO of Truffle Capital.
Prof. Hartmut Ehrlich, CEO of Abivax, added: “Now, with funding for the clinical and development program in place, we are rapidly initiating this rigorously designed clinical trial to hopefully translate the promising features of ABX464 into tangible clinical benefits for the patients. In parallel, we continue the ABX464 Phase 2b trial for ulcerative colitis, Phase 2a for rheumatoid arthritis, and the preparation of a Phase 2b trial for Crohn’s disease. Securing this financing from Bpifrance is a first major step towards funding Abivax for the next 18-24 months.”
Bpifrance is the investment bank of the French state, supporting entrepreneurial activities that are in the public interest.