Abivax's Obefazimod Soars 800% in 2023: Is There Still Upside?

Abivax's shares have surged by 800% this year following positive clinical trial results for its lead candidate, obefazimod. The medicine could be more effective than existing drugs for ulcerative colitis, and there may be upside left if obefazimod produces more positive results in further trials. Abivax's market capitalization is now 3.7 billion euros, and analysts estimate peak sales of around $4 billion.

Abivax's shares have surged by 800% this year following positive clinical trial results for its lead candidate, obefazimod. The medicine could be more effective than existing drugs for ulcerative colitis, and there may be upside left if obefazimod produces more positive results in further trials. Abivax's market capitalization is now 3.7 billion euros, and analysts estimate peak sales of around $4 billion.

Topline data were announced from two phase 3 trials evaluating obefazimod in adults with moderately to severely active ulcerative colitis (UC). Obefazimod is an oral small molecule drug believed to reduce inflammation by enhancing the expression of microRNA-124 (miR-124), which then inhibits the overexpression of multiple proinflammatory cytokines [1].

The randomized, double-blind, placebo-controlled phase 3 trials, ABTECT-1 and ABTECT-2, evaluated the safety and efficacy of obefazimod in participants with UC who had an inadequate response to conventional therapies. Study participants were randomly assigned to receive obefazimod 25mg, 50mg, or placebo once daily with food in the morning for 8 weeks. The primary endpoint was the proportion of patients who achieved clinical remission per Modified Mayo Score at week 8 [1].

Findings showed a higher proportion of patients treated with obefazimod 50mg achieved clinical remission compared with those who received placebo at week 8 (ABTECT-1: placebo-adjusted remission rate, 19.3%; P .0001 and ABTECT-2: placebo-adjusted remission rate, 13.4%; P =.0001). All key secondary endpoints were also met with the 50mg obefazimod dose [1].

The 25mg dose of obefazimod met the primary endpoint of clinical remission in the ABTECT-1 trial but did not meet it in ABTECT-2. The safety profile of obefazimod was consistent with previously reported data, with no new safety signals identified [1].

A 44-week phase 3 maintenance trial is currently underway to evaluate the long-term efficacy and safety of obefazimod 25mg and 50mg in patients with moderately to severely active UC. Topline data are expected to be announced in the second quarter of 2026 [1].

Abivax's CEO, Marc de Garidel, stated, "The strength of these results reinforces our belief in obefazimod, our first-in-class miR-124 enhancer, and its potential to become a transformative new treatment modality for patients with UC. Pending successful results from the 44-week maintenance trial, we are preparing to submit a New Drug Application to the FDA in the second half of 2026" [1].

Abivax's stock reached the stratosphere this past week after the company dazzled investors and analysts with its data from a pair of Phase III induction trials assessing obefazimod in adults with moderately to severely active UC. Abivax's ADSs and European shares rocketed into the stratosphere, leaping nearly six- and seven-fold in U.S. and European trading, respectively [2].

The offering and its expansion capped an historic week for Abivax, in which its ADSs and European shares rocketed into the stratosphere, leaping nearly six- and seven-fold in U.S. and European trading, respectively. On Nasdaq, Abivax ADSs catapulted an eye-popping 586% Wednesday from $10 to $68.60, then rose nearly 2% Thursday to $69.36 before sliding nearly 5% to $66.49 on apparent profit taking. On Euronext Paris, shares soared 510% from €8.90 ($10.45) to €54.30 ($63.73) Wednesday, then advanced another 7% to €58.30 ($68.43) Thursday before dipping 2% to an even €57 ($66.90) on Friday [2].

Abivax plans to spend approximately $140 million to $185 million toward clinical development of obefazimod for UC and approximately $30 million to $65 million toward clinical development of obefazimod for Crohn’s disease. The remainder will be used for working capital and other general corporate purposes, including preparation of commercialization, additional research and development, and financing expenses [2].

Additional positive data for obefazimod was the lower-than-expected placebo response rate, which was 4.4% for the pooled patient population of the ABTECT 8-week studies (2.5% in ABTECT-1, 6.3% in ABTECT-2). While Abivax expected a lower placebo response rate than 12.5% seen in an earlier Phase IIb study, the result exceeded expectations [2].

Obefazimod is a small molecule upregulator of miR-124, an anti-inflammatory microRNA. Obefazimod enhances the selective splicing of a single long noncoding RNA to generate miR-124, which downregulates cytokines and chemokines shown to promote inflammation, including tumor necrosis factor (TNF) alpha, IL-6, monocyte chemoattractant protein-1 (MCP-1) and IL-17, as well as Th17+ cells [2].

If data from the maintenance trial prove positive, Abivax will pursue a New Drug Application (NDA) in the second half of next year, with the aim of launching obefazimod to market in the second half of 2027. Additional positive data for obefazimod was the lower-than-expected placebo response rate, which was 4.4% for the pooled patient population of the ABTECT 8-week studies (2.5% in ABTECT-1, 6.3% in ABTECT-2). While Abivax expected a lower placebo response rate than 12.5% seen in an earlier Phase IIb study, the result exceeded expectations [2].

References:
[1] https://www.gastroenterologyadvisor.com/news/obefazimod-induces-clinical-remission-in-ulcerative-colitis-trials/
[2] https://www.genengnews.com/topics/drug-discovery/stockwatch-abivax-shares-leap-on-phase-iii-ulcerative-colitis-data-747-5m-offering/