Abivax Announces Patient-Reported Outcomes Data from the Phase 3 ABTECT Induction Trials of Obefazimod, Demonstrating Significant Improvements in Quality of Life for Patients with Moderate-to-Severely Active Ulcerative Colitis
Abivax (NASDAQ:ABVX) reported patient-reported outcomes from its Phase 3 ABTECT 8-week induction trials of obefazimod in adults with moderate-to-severely active ulcerative colitis on November 3, 2025. Across PRO instruments, the company observed improvements from baseline to Week 8 for both 50mg and 25mg doses.
Key week‑8 results: 37% of patients on 50mg reported no bowel urgency versus 18.1% on placebo; 47.6% on 50mg reported no nocturnal bowel movements versus 24.7% on placebo; 17.1% on 50mg achieved fatigue remission versus 7.7% on placebo. Detailed PRO data and full analyses will be submitted for upcoming medical meetings; a 44-week maintenance readout is expected Q2 2026.
Abivax (NASDAQ:ABVX) ha riportato i risultati riferiti dai pazienti dai suoi trial di induzione di 8 settimane di fase 3 ABTECT con obefazimod in adulti con colite ulcerosa moderata-severa attiva il 3 novembre 2025. Attraverso gli strumenti PRO, l’azienda ha osservato miglioramenti dal basale fino alla Settimana 8 per entrambe le dosi 50mg e 25mg.
Risultati chiave alla settimana 8: 37% dei pazienti in 50mg non hanno riferito urgenza intestinale rispetto al 18,1% in placebo; 47,6% in 50mg non hanno movimenti intestinali notturni rispetto al 24,7% in placebo; 17,1% in 50mg hanno raggiunto la remissione della stanchezza contro 7,7% in placebo. Verranno presentati dati PRO dettagliati e analisi complete nei prossimi congressi medici; è atteso un risultato di mantenimento a 44 settimane nel secondo trimestre del 2026.
Abivax (NASDAQ:ABVX) presentó resultados reportados por los pacientes de sus ensayos de inducción de 8 semanas de fase 3 ABTECT de obefazimod en adultos con colitis ulcerosa activa moderada-severa el 3 de noviembre de 2025. A través de los instrumentos PRO, la empresa observó mejoras desde el inicio hasta la Semana 8 para ambas dosis de 50mg y 25mg.
Resultados clave en la semana 8: 37% de los pacientes con 50mg reportaron no urgencia intestinal frente a 18,1% con placebo; 47,6% con 50mg reportaron ausencia de movimientos intestinales nocturnos frente a 24,7% placebo; 17,1% con 50mg lograron la remisión de la fatiga frente a 7,7% placebo. Se presentarán datos PRO detallados y análisis completos en próximas reuniones médicas; se espera un resultado de mantenimiento a 44 semanas para el segundo trimestre de 2026.
Abivax (NASDAQ:ABVX)는 성인에서 중등도에서 중증의 활성 궤양성 대장염에 대한 Phase 3 ABTECT의 8주 유도 임상에서 obefazimod에 대한 환자 보고 결과를 2025년 11월 3일에 발표했습니다. PRO 도구를 통해 두 용량 50mg과 25mg 모두에서 기저선 대비 8주 차의 개선이 관찰되었습니다.
주요 8주 차 결과: 50mg 투여군에서 배변 긴급감이 없다고 보고한 환자 비율은 37%로 위약의 18.1%에 비해 높았고, 50mg 투여군에서 야간 배변이 없다고 보고한 비율은 47.6%로 위약의 24.7%에 비해 높았습니다; 피로 완전 관해는 50mg에서 17.1%로 위약의 7.7% 대비 높았습니다. 자세한 PRO 데이터와 전체 분석은 향후 학술대회에서 제출될 예정이며, 2026년 2분기에 44주 유지 관찰 결과가 예정되어 있습니다.
Abivax (NASDAQ:ABVX) a publié les résultats rapportés par les patients de ses essais d’induction de phase 3 ABTECT sur 8 semaines avec obefazimod chez des adultes atteints de colite ulcéreuse active modéréeà sévère, le 3 novembre 2025. À travers les instruments PRO, la société a observé des améliorations depuis la ligne de base jusqu’à la Semaine 8 pour les deux doses 50mg et 25mg.
Résultats clés à la semaine 8 : 37% des patients sous 50mg n’ont rapporté aucune urgence intestinale contre 18,1% sous placebo ; 47,6% sous 50mg n’ont pas eu de mouvements intestinaux nocturnes contre 24,7% sous placebo ; 17,1% sous 50mg ont atteint une rémission de la fatigue contre 7,7% sous placebo. Des données PRO détaillées et des analyses complètes seront soumises lors de prochaines réunions médicales; un résultat de maintenance à 44 semaines est attendu au Q2 2026.
Abivax (NASDAQ:ABVX) berichtete Patientenberichte aus den Phase-3-8-Wochen-Induktionsstudien ABTECT von obefazimod bei Erwachsenen mit moderat bis schwer aktivem Colitis ulcerosa am 3. November 2025. Über PRO-Instrumente hinweg zeigte das Unternehmen Verbesserungen vom Ausgangswert bis Woche 8 für beide Dosen 50mg und 25mg.
Wichtige Ergebnisse nach Woche 8: 37% der Patienten unter 50mg berichteten keine Darmdrängel, verglichen mit 18,1% Placebo; 47,6% unter 50mg berichteten keine nächtlichen Darmbewegungen verglichen mit 24,7% Placebo; 17,1% unter 50mg erreichten Remission von Fatigue gegenüber 7,7% Placebo. Detaillierte PRO-Daten und vollständige Analysen werden bei kommenden medizinischen Meetings eingereicht; eine 44-Wochen-Wartungs-Readout wird für das zweite Quartal 2026 erwartet.
Abivax (NASDAQ:ABVX) أصدرت نتائج مُبلَّغ عنها من قبل المرضى ل trials المرحلة 3 الخاصة بتحفيز 8 أسابيع من ABTECT لـ obefazimod لدى البالغين المصابين بالتهاب القولون التقرحي النشط من الدرجة المتوسطة إلى الشديدة في 3 نوفمبر 2025. عبر أدوات PRO، لاحظت الشركة تحسينات من خط الأساس حتى الأسبوع 8 لكِلا الجرعتين 50mg و25mg.
نتائج أسبوع-8 الرئيسية: 37% من المرضى على 50mg أبلغوا عن عدم وجود urgency في الأمعاء مقابل 18.1% في الدواء الوهمي؛ 47.6% من 50mg أبلغوا عن عدم وجود حركات أمعاء ليليّة مقابل 24.7% في-placebo؛ 17.1% من 50mg حققوا انخفاضًا في التعب مقابل 7.7% في-placebo. ستُقدَّم بيانات PRO مفصّلة وتحليلات كاملة في المؤتمرات الطبية القادمة؛ ومن المتوقع قراءة صيانة لمدة 44 أسبوعًا في الربع الثاني من 2026.
- No bowel urgency in 37% of 50mg patients at Week 8
- No nocturnal bowel movements in 47.6% of 50mg patients at Week 8
- Fatigue remission in 17.1% of 50mg patients at Week 8
- Consistent PRO improvements across multiple instruments (QoL, WPAI, FACIT-F)
- Data reported are short‑term (8‑week induction) with no long‑term results yet
- Detailed PRO datasets not yet publicly presented—full analysis pending conference
Insights
Phase 3 patient‑reported outcomes show statistically significant quality‑of‑life gains for obefazimod; key next steps are dataset disclosure and maintenance results.
Abivax reported consistent improvements across multiple patient‑reported outcome measures at Week 8 in the ABTECT induction trials, including
The business mechanism is straightforward: demonstrable, statistically significant PRO benefits strengthen the clinical profile of obefazimod by showing symptomatic and quality‑of‑life improvements that payers and clinicians value when assessing treatment adoption. Dependencies and risks include the need for full, peer‑reviewed PRO datasets to confirm subgroup consistency, durability beyond eight weeks, and regulatory reviewers’ assessment of PROs alongside primary clinical endpoints. The company explicitly plans to present detailed PRO data at upcoming medical meetings and to report 44‑week maintenance trial results in
Abivax Announces Patient-Reported Outcomes Data from the Phase 3 ABTECT Induction Trials of Obefazimod, Demonstrating Significant Improvements in Quality of Life for Patients with Moderate-to-Severely Active Ulcerative Colitis
- Improvements across all patient reported outcomes (PROs) were observed from baseline to Week 8 in all PRO instruments utilized in the ABTECT induction trials evaluating bowel urgency, sleep interruption, fatigue, quality of life, and work productivity for both 50mg and 25mg once-daily obefazimod.
- At week 8 in the ABTECT 1 & 2 trials,
37% of patients taking once daily 50mg obefazimod reported no bowel urgency (BU) compared to18.1% of patients in the placebo group (18.9, p<0.00011), with improvements in BU observed as early as week two 47.6% of patients on 50mg obefazimod reported no nocturnal bowel movements (NBM) at week 8 compared to24.7% in the placebo group (23.1, p<0.00011)- In the 50 mg group
17.1% of patients reported fatigue remission as measured with the Fatigue Numerical Rating Scale (NRS) at week 8, compared to7.7% in the placebo group ( 9.5, p=0.00011) - Detailed data across PROs, including data for both 25mg and 50mg groups, to be submitted for presentation at upcoming medical meetings
PARIS, France – November 3, 2025 – 10:05 PM CET – Abivax SA (Euronext Paris: FR0012333284 – ABVX / 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 patient-reported outcomes (PRO) from its Phase 3 ABTECT 8-week induction trials evaluating obefazimod in adult patients with moderate-to-severely active ulcerative colitis (UC). In addition to the trials’ clinical efficacy endpoints, PRO instruments are important in determining how patients perceived changes in their symptoms, quality of life, and activities of daily living.
“Ulcerative colitis can be a devastating condition that affects every aspect of a person’s daily life, including their ability to work, socialize, and maintain their emotional well-being,” said Marla Dubinsky, MD2, Professor of Pediatrics and Medicine, Chief, Division of Pediatric Gastroenterology and Nutrition, Co-Director, Susan and Leonard Feinstein IBD Clinical Center, Mount Sinai Kravis Children’s Hospital, Icahn School of Medicine Mount Sinai New York. “For these patients, improvement isn’t just about controlling inflammation, it’s about regaining a sense of normalcy. That’s why measures of quality of life are so important when evaluating potential new therapies so that we also capture the outcomes that truly matter to patients, and bowel urgency is one of these key factors. The consistency of improvements across all PRO instruments utilized in this program underscores the meaningful benefit obefazimod provided to patients’ daily experience and supports the positive Phase 3 efficacy results observed at week 8. Together, these results highlight obefazimod’s potential to meaningfully advance care for patients with UC."
PRO instruments evaluated in the ABTECT trials include:
- Bowel urgency
- Nocturnal bowel movement
- Fatigue numerical rating scale (NRS)
- Fatigue and ability to function (FACIT-F)
- Inflammatory bowel disease questionnaire (IBDQ)
- Overall quality of life (EQ-5D-5L)
- Workplace productivity (WPAI Domains)
Detailed analysis of these PROs will be submitted for presentation at an upcoming medical conference.
Marc de Garidel, MBA, Chief Executive Officer of Abivax, commented, “The data shared today further support obefazimod's potential as a meaningful treatment option for patients with ulcerative colitis (UC). Our development efforts, guided by the recognized need for more effective and tolerable long-term therapies, are focused on advancing treatments that can significantly improve patients' quality of life. Taken together with the previously reported positive ABTECT 8-week induction trial results, we are one step closer to realizing this goal. We will be submitting more detailed aspects of this dataset for presentation at an upcoming medical meeting and look forward to sharing results from our 44-week maintenance trial in the second quarter of 2026.”
About Abivax
Abivax is 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. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis.
Contact:
Patrick Malloy
SVP, Investor Relations
Abivax SA
patrick.malloy@abivax.com
+1 847 987 4878
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business. Words such as “anticipate,” “expect,” “potential” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the Company’s anticipated timing for data readouts of its ABTECT induction and maintenance clinical trials and the potential therapeutic benefit of obefazimod. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 24, 2025 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.
1 ABTECT-1&2 pooled analysis; all p-values are nominal. Endpoints are secondary and not alpha controlled.
2 Marla Dubinsky, MD is a paid consultant for Abivax.
FAQ
What PRO improvements did Abivax (ABVX) report on November 3, 2025 for obefazimod Week 8?
How soon did bowel urgency improve in ABTECT trials for ABVX obefazimod?
When will Abivax (ABVX) release detailed ABTECT PRO data and maintenance results?
Which patient‑reported instruments were used in ABTECT Phase 3 for ABVX obefazimod?
What doses of obefazimod were evaluated in the ABTECT Phase 3 induction trials (ABVX)?
