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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #21.14

Abivax reports positive phase 2b results of ABX464 in ulcerative colitis

In the evening of May 24, Abivax, a Paris-based biotechnology company, released remarkable results of ABX464 in a randomized, double-blind phase 2b clinical trial in ulcerative colitis and announced plans to proceed to phase 3 by the end of the year. Abivax shares were up 52% to €33.6 on Wednesday, May 25.

The top-line data showed significant clinical efficacy, on primary and key secondary endpoints in 254 patients with moderate to severe ulcerative colitis, of ABX464 (at 25mg, 50mg and 100mg) during 8 weeks of induction treatment.

In addition, after 48 weeks of open-label maintenance treatment with ABX464, preliminary data from the first 51 patients showed further increased clinical and endoscopic efficacy. Furthermore, ABX464 was also effective at the lowest dose of 25 mg including in patients who previously failed biologic and/or JAK treatment and had a durable effect during maintenance treatment.

ABX464 was well tolerated at all dose levels including in the several hundreds of COVID-19 patients were the drug failed to show efficacy earlier this year.

ABX464 acts through a novel mechanism of action based on the upregulation of a single microRNA (miR-124) which downregulates pro-inflammatory cytokines and chemokines in acting as a “putting brake” on inflammation processes. ABX464 is well suited to become a potential important new treatment for all kinds of chronic inflammation.

For the time being, Abivax will concentrate its efforts in the treatment of chronic inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease, a market worth $25 billion by 2025, the year ABX464 is expected to reach the market.

Abivax is also currently running a phase 2 clinical trial in rheumatoid arthritis and in other chronic inflammatory diseases, where the overall estimated world market is currently around $65 billion.

Abivax management announced that it has cash to cover all expenses until the end of Q4 2021 and that its preferred current option is to find a large biopharmaceutical partner, with a strong footprint in the U.S., to finance the costly phase 3 clinical trials which are planned to start at the end of 2021 and sometime in 2022.

Following the publication of the excellent efficacy and safety results obtained with ABX464, we can easily forecast that, right now, business development and financial departments in a dozen of biopharmaceutical companies are actively assessing the potential value of ABX464 in order to fine tune their offer. Many questions addressing Abivax’s strategic vision will probably be raised at the forthcoming shareholder’s annual general meeting of June 4, 2021.

Paris, May 26, 2021.

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