Key Highlights

• 37.2% of Non-Responders Achieved Remission: Patients who failed induction had a 37.2% clinical remission rate in the ABTECT Maintenance Part 2 study, a meaningful result for a refractory population.

• Dose Escalation Rescues Relapsed Patients: 45.5% of patients who relapsed during maintenance successfully regained remission through dose escalation, demonstrating treatment flexibility.

• Long-Term Safety Favorable: Malignancy rates in long-term Phase 3 data aligned with standard ulcerative colitis background rates, addressing a key safety concern.

Abivax (NASDAQ: ABVX) reported encouraging data from its ABTECT Maintenance Part 2 study evaluating obefazimod for ulcerative colitis, with the results driving a 39% share price gain to close at $133.69 as investors responded positively to evidence of clinical activity in a challenging patient population.

The study's findings revealed that 37.2% of patients who had initially not responded during the induction phase of treatment subsequently achieved clinical remission during the maintenance period, a meaningful efficacy signal in a population typically considered more resistant to therapeutic intervention.

Additionally, 45.5% of patients who relapsed during maintenance successfully regained remission following dose escalation, demonstrating an important clinical flexibility for the drug that could translate into meaningful real-world utility as physicians seek to manage relapsing-remitting disease courses over time.

Long-term Phase 3 safety results showed malignancy rates aligned with standard ulcerative colitis background levels, addressing what had been a key area of investor scrutiny for a drug targeting a chronic inflammatory condition requiring potentially long-duration treatment. Favorable malignancy safety data is critical for chronic disease therapeutics seeking broad commercial adoption.

Obefazimod's ability to rescue both initial non-responders and relapsed patients positions it potentially as a versatile treatment option in the ulcerative colitis therapeutic landscape, where a meaningful proportion of patients fail or lose response to first-line biologics and face limited subsequent treatment options. Abivax (NASDAQ: ABVX) will need to continue building out its regulatory submissions to convert this clinical momentum into an approval pathway.

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