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Abivax SA (PARIS:FR, NASDAQ:ABVX) ("Abivax" or the "Company"), a clinical-stage biotechnology company focused on developing therapeutics that harness the body's natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced additional clinical data for obefazimod were delivered in a second late-breaking presentation at the United European Gastroenterology (UEG) Meeting in Berlin, Germany. These data, from the Phase 3 ABTECT 8-Week Induction Trials investigating obefazimod for the treatment of moderate-to-severely active ulcerative colitis, highlight additional efficacy endpoint data at week 8 for patients with and without prior advanced therapy inadequate response (AT-IR).
"Despite advances in care, many patients with ulcerative colitis continue to struggle with inadequate disease control and safety concerns that significantly impact their quality of life," said Silvio Danese, MD, PhD, Professor of Gastroenterology, IRCCS San Raffaele Scientific Institute, and UEG President Elect. "The outstanding results shared today demonstrate meaningful improvements across a spectrum of patients with ulcerative colitis, ranging from those who were naïve to advanced therapies to those who have failed up to 4+ lines of prior advanced therapy, including JAK inhibitors. Taken together with the clinically meaningful improvements across all efficacy endpoints and a continued favorable safety profile, these findings highlight obefazimod's potential in becoming the standard of care for treating a broad spectrum of patients with ulcerative colitis."
Study Population: A total of 1272 patients were enrolled across the ABTECT trials, with approximately 60% being classified as having an endoscopic subscore of 3. Of the total pooled population, approximately 47% were classified as having a prior inadequate response to advanced therapy (‘AT-IR Yes') with approximately 21% having failed to respond to a JAK inhibitor. The populations in the pooled ABTECT 1 & 2 trials were generally well balanced.
Results: 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% (p<0.0001), and in participants with up to four or more prior AT-IR, a placebo-adjusted difference of 29% (p=0.0242). Treatment with obefazimod 50mg also demonstrated robust clinical response in participants who had previously failed JAK inhibitor therapy, with a placebo-adjusted difference of 34% (p=0.0017). Treatment with 50mg obefazimod achieved clinically meaningful improvements in endoscopic and histologic endpoints, regardless of prior AT-IR. In addition, for participants without prior AT-IR, the 25mg and 50mg once-daily doses of obefazimod achieved similar efficacy across clinical, endoscopic, and histologic endpoints. Obefazimod continued to be well tolerated with no new safety signals identified.
† ABTECT-1&2 pooled analysis; all p-values are nominal; AT-IR was defined as inadequate response, loss of response, or intolerance to advanced therapies including biologics, JAK inhibitors, and S1P modulators
