Btobioinnovation.com 

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

SPECIAL REPORT 25.07

Abivax: Ahead of a bright future?

On Tuesday, July 22, just after the closure of Wall Street, Abivax announced positive phase 3 results for the treatment of ulcerative colitis (UC). The Paris and Boston-based biotechnology company conducted two clinical studies (ABTECT-1 and ABTECT-2 in 8 week induction trials) investigating its drug obefazimod in moderate and severe active ulcerative colitis patients. The 50 mg dose achieved a 16,4% placebo-adjusted remission rate at week 8 in 636 patients, a result which was superior to the one reported in previous phase 2 studies. The results for the 25 mg dose did reach statistical significance in the 160 patients from ABTECT-1 study but not in the 159 patients in the ABTECT-2 study. Upon the announcement of these results Abivax stock soars to 56 euros on the Paris exchange, after closing at 8.90 euros the previous day, an increase of more than 500% in a single day, an exceptional soaring in recent time.  “Today marks a significant milestone for Abivax and more importantly for the ulcerative colitis community. The strength of these results reinforces our belief in obefazimod, a first in class agent and its potential to become a transformative new treatment modality for patients with UC”, said Marc de Garidel, the CEO of Abivax

Obefazimod is a small orally active molecule, with a novel mechanism of action, which enhances the expression of miR-124, a naturally occurring microRNA that plays a critical role in regulating the immune response.

Abivax will now be conducting a 44 week maintenance trial with results expected in the second quarter of 2026, allowing the company to submit applications in Europe and in the US in the second half of next year.

Obefazimod is a first in class treatment for inflammatory bowel diseases (IBD), a therapeutic area which has attracted many large pharmaceutical companies around the world. The ulcerative colitis market was estimated to hit $9.6 billion in 2031 and according to Leerink Partners the market for IBD which includes both ulcerative colitis and Crohn’s disease could reach $30 billion by 2030.  Leerink Partners analyst Thomas Smith forecasts obefazimod to generate peak sales of about $4 billion for IBD compared to $2.6 billion previously. “More detailed analysis including patients with inadequate response to prior JAK therapy will be presented at an upcoming medical conference“ wrote Fabio Cataldi, Abivax Chief Medical Officer.

Why was the stock market value of Abivax so strongly undervalued previously? The question requests more than a single answer.

1. The mechanism of action of obefazimod is novel and had only be proven in phase 2 studies but not in a large, more than 1 200 patients with moderate to severe UC, phase 3 study. The associated risk of failure is now fully alleviated. The drug has a a great potential based on its “compelling balance of efficacy, safety and convenience” wrote Thomas Smith in a note to Leerink Partners clients.
2. The UC market is pretty crowed with major players such as AbbVie, Eli Lilly, Merck, Roche and Pfizer already in place in the US.
3. Abivax has not yet evidence in phase 2 studies that obefazimod is acting as efficiently and safely in Crohn’s disease as it does in ulcerative colitis. The Crohn’s disease market is two to three times bigger than the UC one.
4. Obefazimod is a molecule with an original patent issued many years ago when it was assessed as an anti HIV agent and its exclusivity in the IBD market needs to be thoroughly assessed.
5. European biotechnology companies, and in particular French ones, are valued two to three times lower than their US competitors.

Paris, July 24, 2025.

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