Abivax SA, a French biotech company listed on Euronext Paris and Nasdaq, is developing a new class of drugs that target the body’s own immune regulators to treat chronic inflammatory diseases.

The company’s lead candidate, obefazimod, is in late-stage clinical trials for ulcerative colitis (UC), a type of inflammatory bowel disease (IBD) that affects the large intestine. Abivax also plans to test obefazimod in Crohn’s disease (CD), another form of IBD that can affect any part of the digestive tract.

Marc de Garidel, Chief Executive Officer of Abivax, says: “We are on track to deliver our strategic roadmap as laid out in September last year to prepare obefazimod for commercialization if approved, starting with ulcerative colitis in the US. Our US office has recently been opened and we have completed the recruitment of a very experienced team with a particular focus in the US. For 2024, our priority stays on the completion of patient recruitment into the ABTECT Phase 3 induction trials.”

Didier Blondel, Chief Financial Officer of Abivax, adds: “With the successful Nasdaq IPO in October 2023, the largest ever Nasdaq IPO of a French-listed biotech company, we expect to be fully financed through the planned data read-outs of the UC and CD induction trials. In parallel, we continue to implement our multi-pronged financing strategy to fund our ambitious projects in 2024 and beyond, with the objective to increase shareholder value.”

Obefazimod Phase 3 program in UC

Obefazimod is a small molecule that modulates the expression of microRNA-124, a key regulator of inflammation and immune tolerance. By restoring the balance of microRNA-124, obefazimod aims to reduce inflammation and promote tissue repair in patients with UC.

Abivax is conducting a global Phase 3 program, called ABTECT, to evaluate the efficacy and safety of obefazimod in adults with moderate to severe UC who have failed or are intolerant to conventional therapies. The program consists of two identical induction trials, ABTECT-1 and ABTECT-2, followed by a maintenance trial. The primary endpoint of the induction trials is clinical remission at week 8, defined as a Modified Mayo Score of 2 or less with no individual subscore greater than 1. The primary endpoint of the maintenance trial is clinical remission at week 52, which is week 44 of the maintenance period.

Abivax expects to enroll 1,200 UC patients across 36 countries in over 600 trial sites. The company plans to complete the enrollment of the last patient into the induction trials by the fourth quarter of 2024, and to report the top-line results of the induction trials in the first quarter of 2025. The top-line results of the maintenance trial are expected in the first quarter of 2026.

The ABTECT program is designed to support the regulatory approval of obefazimod as a potentially differentiated oral treatment option for UC patients. Abivax believes that obefazimod could become a first-line advanced therapy for UC, given its favorable safety profile, convenient dosing, and novel mechanism of action.

Obefazimod 25 mg long-term extension trial in UC

Abivax has also initiated a long-term extension trial for UC patients who have completed the Phase 2a or Phase 2b maintenance trials with obefazimod. The extension trial allows patients to continue receiving obefazimod at a reduced dose of 25 mg once daily, which is half of the dose used in the Phase 3 program.

The interim analysis of the extension trial, as of July 31, 2023, showed that obefazimod maintained disease control in 84% of the 63 patients who completed their 48-week visit. Disease control was measured by the Modified Mayo Score, which assesses the severity of UC symptoms such as stool frequency, rectal bleeding, and endoscopic appearance. No new safety signals were detected in UC patients treated with obefazimod for up to five years.

Abivax plans to report new data from the extension trial in the third quarter of 2024, after one and two years of continued treatment with the 25 mg dose of obefazimod. The company hopes to confirm the long-term safety and efficacy of obefazimod, as well as its potential to reduce the dose for chronic use. Abivax will also conduct further analyses of clinical laboratory parameters to validate obefazimod’s mechanism of action and its ability to relieve UC symptoms.

Obefazimod Phase 2 trial in Crohn’s disease

Based on the encouraging preclinical and clinical data of obefazimod in IBD, Abivax is expanding its development program to include CD, a chronic inflammatory condition that can affect any part of the digestive tract and cause symptoms such as abdominal pain, diarrhea, weight loss, and fistulas.

Abivax is preparing to launch a Phase 2 trial, called ENHANCE-CD, to test the efficacy and safety of obefazimod in adults with moderate to severe CD who have failed or are intolerant to conventional therapies. The primary endpoint of the trial is clinical remission at week 12, defined as a Crohn’s Disease Activity Index (CDAI) score of less than 150.

Abivax submitted an Investigational New Drug (IND) application for ENHANCE-CD to the US Food and Drug Administration (FDA) in the fourth quarter of 2023, and received clearance to proceed with the trial. The company is currently evaluating the FDA comments and will consider any recommended adjustments to the trial design. Abivax expects to report the top-line results of the induction phase of the trial in the second half of 2025, pending the decision to modify the trial design after the evaluation of the FDA comments.

The ENHANCE-CD trial is intended to demonstrate the safety and efficacy of obefazimod in CD, and to replicate the positive results obtained in UC. Abivax aims to establish obefazimod as a potential oral treatment for both forms of IBD, which affect millions of people worldwide.

R&D progress

Abivax is also exploring other opportunities to leverage the potential of obefazimod and its compound library. The company is conducting a formal process to evaluate the possibility of combining obefazimod with other oral or injectable candidates in UC, based on its early clinical profile. Abivax expects to generate preclinical data to support the decision-making on a combination agent in the second half of 2024.

In addition, Abivax is working on selecting the first follow-on drug candidate from its compound library, which contains over 1,000 molecules that modulate microRNA-124 or other immune regulators. The company expects to announce the selection of the first follow-on candidate in the third quarter of 2024, to further strengthen its pipeline and diversify its portfolio.

Abivax is confident that its innovative approach to modulating the immune system could lead to breakthrough therapies for patients with chronic inflammatory diseases, as well as other indications such as viral infections, cancer, and neurodegenerative disorders. The company is committed to advancing its clinical programs and delivering value to its shareholders and stakeholders.

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