Abivax SA (NASDAQ:ABVX, EPA:ABVX, FRA:2X10, FRA:2X1) shares surged more than 40% on Tuesday after the French biotech released updated safety data from its late-stage ulcerative colitis program for its investigational drug obefazimod, easing earlier market concerns around reported cancer cases in the study.
The company said the additional analysis showed that observed malignancy rates across its Phase 2 and Phase 3 program were consistent with background rates typically seen in patients with ulcerative colitis.
In the latest update, Abivax highlighted integrated exposure data covering 1,704 patient-years across its clinical program. It reported exposure-adjusted incidence rates for malignancies excluding non-melanoma skin cancer of 0.35 and 0.64 events per 100 patient-years in combined and 50 mg cohorts respectively, alongside rates for non-melanoma skin cancer of 0.59 and 0.64 events per 100 patient-years. The company said these figures were in line with expected background incidence in the ulcerative colitis population.
In the ABTECT Maintenance Part 2 study, which included more refractory patients who had not responded to induction therapy or had relapsed during earlier maintenance treatment, the company also reported continued efficacy signals for obefazimod. At week 44, 37.2% of induction non-responders achieved clinical remission, while 34.5% achieved endoscopic remission under continued 50 mg dosing.
The study also found that dose escalation to 50 mg helped restore clinical remission in 45.5% of patients who had relapsed during an earlier maintenance phase, supporting the use of a flexible dosing approach to regain disease control.
Abivax SA (NASDAQ:ABVX, EPA:ABVX)id the expanded dataset strengthens the overall safety database for obefazimod ahead of a planned regulatory submission later this year.
“The results from ABTECT Maintenance Part 2 represent an important milestone in the clinical development of obefazimod, demonstrating meaningful clinical benefit in patients with highly refractory ulcerative colitis while substantially expanding our long-term safety database,” Abivax CEO Marc de Garidel said in a statement.
“Together with the unprecedented efficacy results from the ABTECT Phase 3 program, these findings build a comprehensive body of evidence supporting the potential of obefazimod to address significant unmet needs across a broad spectrum of patients living with ulcerative colitis.”
The update comes roughly a month after Abivax stock fell as much as 40% following a prior readout that disclosed seven cancer diagnoses across the trial population. Investigators had previously assessed those cases as unlikely to be related to treatment, but the disclosure weighed heavily on sentiment at the time.
