Abivax SA (NASDAQ:ABVX) shared additional clinical data on Monday for obefazimod at the United European Gastroenterology (UEG) Meeting.
These data, from the Phase 3 ABTECT 8-Week Induction Trials investigating obefazimod for moderate-to-severely active ulcerative colitis, highlight additional efficacy endpoint data at week eight for patients with and without prior advanced therapy inadequate response (AT-IR).
A total of 1,272 patients were enrolled across the ABTECT trials.
In the pooled ABTECT 1 & 2 trials, treatment with once-daily obefazimod 50mg achieved clinically meaningful improvements in clinical response across all subgroups, including participants with prior AT-IR.
In participants without prior AT-IR, obefazimod 50mg delivered a placebo-adjusted difference in clinical response of 28%, and in participants with up to four or more prior AT-IR, a placebo-adjusted difference of 29%.
Treatment with obefazimod 50mg also demonstrated a robust clinical response in participants who had previously failed JAK inhibitor therapy, with a placebo-adjusted difference of 34%. It also achieved clinically meaningful improvements in endoscopic and histologic endpoints, regardless of prior AT-IR.
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Additionally, for participants without prior AT-IR, the 25mg and 50mg once-daily doses of obefazimod demonstrated similar efficacy across clinical, endoscopic, and histological endpoints.
Obefazimod continued to be well-tolerated with no new safety signals identified.
On Sunday, the company presented results from its Phase 3 ABTECT 8-Week Induction Trials investigating obefazimod, including previously reported findings and additional safety data at week eight.
No signal for serious, severe, or opportunistic infections or malignancies was observed.
Results from the trials demonstrated that obefazimod met its FDA primary endpoint of clinical remission at Week 8 in the 50 mg once-daily dose regimen for both trials.
ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% and ABTECT-2 demonstrated 13.4%, each at the 50 mg once-daily dose, with all key secondary efficacy endpoints being met.
Price Action: ABVX stock is up 5.71% at $88.72 at the last check on Monday.
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