Abivax Announces Completion of Enrollment for the Phase 3 ABTECT Trials in Patients with Moderately to Severely Active Ulcerative Colitis
Abivax has successfully completed enrollment for its Phase 3 ABTECT trials studying obefazimod in patients with moderate to severe ulcerative colitis. The trials exceeded their target by enrolling 1,275 participants (4% above target of 1,224).
Key timeline expectations include:
- Top-line results from 8-week induction trials in Q3 2025
- 44-week maintenance data in Q2 2026
- New Drug Application submission planned for H2 2026
The study's baseline characteristics match the Phase 2b trial profile, with 65% of participants having severe disease (MMS 7-9), 48% experiencing prior advanced therapy failure, and 42% using corticosteroids. The trial spans multiple regions, with significant participation from Eastern Europe (38%), Asia (24%), and Western/Central Europe (22%). The company's cash runway extends through the induction trials readout into Q4 2025.
Abivax ha completato con successo il reclutamento per i suoi studi di Fase 3 ABTECT che indagano l'obefazimod in pazienti con colite ulcerosa da moderata a grave. Gli studi hanno superato l'obiettivo previsto, arruolando 1.275 partecipanti (4% in più rispetto al target di 1.224).
Le principali scadenze previste sono:
- Risultati principali dai trial di induzione di 8 settimane nel terzo trimestre 2025
- Dati di mantenimento a 44 settimane nel secondo trimestre 2026
- Presentazione della domanda di Nuovo Farmaco prevista per la seconda metà del 2026
Le caratteristiche di base dello studio corrispondono al profilo del trial di Fase 2b, con il 65% dei partecipanti affetti da malattia grave (MMS 7-9), il 48% con fallimento di terapie avanzate precedenti e il 42% in trattamento con corticosteroidi. Lo studio si svolge in diverse regioni, con un'importante partecipazione dall'Europa dell'Est (38%), dall'Asia (24%) e dall'Europa Occidentale/Centrale (22%). La liquidità dell'azienda copre il periodo fino ai risultati dei trial di induzione, previsti per il quarto trimestre 2025.
Abivax ha completado con éxito el reclutamiento para sus ensayos de Fase 3 ABTECT que estudian obefazimod en pacientes con colitis ulcerosa de moderada a grave. Los ensayos superaron su objetivo al inscribir a 1,275 participantes (4% por encima del objetivo de 1,224).
Las expectativas clave en el cronograma incluyen:
- Resultados principales de los ensayos de inducción de 8 semanas en el tercer trimestre de 2025
- Datos de mantenimiento a 44 semanas en el segundo trimestre de 2026
- Presentación de la Solicitud de Nuevo Medicamento prevista para la segunda mitad de 2026
Las características basales del estudio coinciden con el perfil del ensayo de Fase 2b, con un 65% de participantes con enfermedad grave (MMS 7-9), un 48% con fracaso previo de terapias avanzadas y un 42% usando corticosteroides. El ensayo abarca múltiples regiones, con participación significativa de Europa del Este (38%), Asia (24%) y Europa Occidental/Central (22%). La liquidez de la compañía cubre hasta la publicación de resultados de los ensayos de inducción en el cuarto trimestre de 2025.
Abivax는 중등도에서 중증 궤양성 대장염 환자를 대상으로 하는 3상 ABTECT 시험의 등록을 성공적으로 완료했습니다. 시험은 목표 인원 1,224명보다 4% 많은 1,275명을 등록했습니다.
주요 일정 예상은 다음과 같습니다:
- 8주 유도 시험의 주요 결과는 2025년 3분기 발표 예정
- 44주 유지 데이터는 2026년 2분기 발표 예정
- 신약 신청서 제출은 2026년 하반기 계획
연구의 기본 특성은 2b상 시험 프로필과 일치하며, 참가자의 65%가 중증 질환(MMS 7-9), 48%가 이전 고급 치료 실패 경험, 42%가 코르티코스테로이드를 사용 중입니다. 시험은 동유럽(38%), 아시아(24%), 서유럽/중앙유럽(22%) 등 여러 지역에서 진행됩니다. 회사의 현금 유동성은 유도 시험 결과 발표 시점인 2025년 4분기까지 유지됩니다.
Abivax a réussi à terminer le recrutement pour ses essais de Phase 3 ABTECT étudiant l'obefazimod chez des patients atteints de colite ulcéreuse modérée à sévère. Les essais ont dépassé leur objectif en recrutant 1 275 participants (4 % au-dessus de l'objectif de 1 224).
Les principales échéances prévues sont :
- Résultats principaux des essais d'induction de 8 semaines au troisième trimestre 2025
- Données de maintien à 44 semaines au deuxième trimestre 2026
- Soumission de la demande d'autorisation de mise sur le marché prévue pour le second semestre 2026
Les caractéristiques de base de l'étude correspondent au profil de l'essai de Phase 2b, avec 65 % des participants présentant une maladie sévère (MMS 7-9), 48 % ayant échoué à des traitements avancés antérieurs et 42 % utilisant des corticostéroïdes. L'essai couvre plusieurs régions, avec une participation importante d'Europe de l'Est (38 %), d'Asie (24 %) et d'Europe de l'Ouest/Centrale (22 %). La trésorerie de l'entreprise couvre la période jusqu'aux résultats des essais d'induction, attendus au quatrième trimestre 2025.
Abivax hat die Rekrutierung für seine Phase-3-Studien ABTECT zur Untersuchung von Obefazimod bei Patienten mit mittelschwerer bis schwerer Colitis ulcerosa erfolgreich abgeschlossen. Die Studien übertrafen ihr Ziel und rekrutierten 1.275 Teilnehmer (4 % über dem Ziel von 1.224).
Wichtige Zeitplan-Erwartungen umfassen:
- Ergebnisse aus den 8-wöchigen Induktionsstudien im 3. Quartal 2025
- Daten zur 44-wöchigen Erhaltung im 2. Quartal 2026
- Geplante Einreichung des Zulassungsantrags für das 2. Halbjahr 2026
Die Baseline-Charakteristika der Studie entsprechen dem Profil der Phase-2b-Studie, wobei 65 % der Teilnehmer eine schwere Erkrankung (MMS 7-9) aufweisen, 48 % zuvor eine fortgeschrittene Therapie nicht erfolgreich hatten und 42 % Kortikosteroide verwenden. Die Studie erstreckt sich über mehrere Regionen mit bedeutender Beteiligung aus Osteuropa (38 %), Asien (24 %) und Westeuropa/Zentraleuropa (22 %). Die Liquiditätsausstattung des Unternehmens reicht bis zum Ergebnisbericht der Induktionsstudien im 4. Quartal 2025.
- Exceeded Phase 3 trial enrollment target by 4% with 1,275 participants
- Blinded baseline characteristics align with Phase 2b trial, increasing confidence in potential efficacy
- Cash runway secured through Q4 2025, covering crucial induction trials readout
- No new safety signals observed in latest DSMB review (April 25, 2025)
- Maintenance study enrollment already exceeds minimum statistical requirements with 597 participants
- Final trial results not expected until Q3 2025 (induction) and Q2 2026 (maintenance)
- NDA submission delayed until H2 2026, extending time to potential market entry
- Cash runway only extends through Q4 2025, may require additional funding before NDA submission
- Geographic distribution shows limited North American presence (10% of trial participants)
Insights
Abivax hits milestone with Phase 3 enrollment completion, exceeding targets with 1,275 patients and confirming key 2025-2026 readout timeline.
Abivax's announcement marks a significant operational achievement with completed enrollment for their Phase 3 ABTECT program, exceeding their 1,224 patient target by 4% with 1,275 participants. This enrollment success positions their obefazimod trials among the largest ulcerative colitis (UC) studies conducted. The maintenance study has already enrolled 597 participants in the responder arm, surpassing the statistical power requirements.
The consistency between Phase 3 and Phase 2b baseline characteristics is methodologically important: 65% of participants exhibit high disease severity scores (MMS 7-9) and 48% have failed prior advanced therapies - identical to Phase 2b figures. This participant profile targets a challenging-to-treat UC population, potentially strengthening the drug's clinical positioning if successful.
The geographic distribution shows diversity with significant representation from Eastern Europe (38%), Asia (24%), and Western/Central Europe (22%). The April 25th Data Safety Monitoring Board review revealed no new safety signals, reinforcing obefazimod's developing safety profile.
The company has established clear development milestones: topline induction results in Q3 2025, maintenance data in Q2 2026, and potential NDA submission in H2 2026. This defined timeline provides concrete benchmarks for tracking the program's progress through clinical development and regulatory phases.
Abivax demonstrates operational efficiency with trial enrollment success and confirms cash runway aligned with Q3 2025 data readout milestone.
Abivax's successful completion of Phase 3 ABTECT trial enrollment represents efficient clinical execution in a complex therapeutic area. The 1,275 participant enrollment (4% above target) demonstrates operational capabilities crucial for advancing late-stage assets. Most significantly, the company has confirmed cash runway through the induction trial readout and into Q4 2025, aligning financial resources with their next potential value inflection point.
This financial positioning is strategically important for a clinical-stage company, as it ensures they can reach their primary Phase 3 data readout without immediate financing pressure. The well-defined clinical and regulatory timeline creates visibility around key value-driving events: induction data in Q3 2025, maintenance data in Q2 2026, and potential NDA submission in H2 2026.
The consistency between Phase 3 and Phase 2b participant characteristics (identical 48% prior advanced therapy failure rates) reinforces the methodological rigor of the program. For a company developing a potential treatment for moderately to severely active ulcerative colitis, this operational execution in maintaining enrollment timelines and target population characteristics represents important progress in their clinical development strategy.
Abivax Announces Completion of Enrollment for the Phase 3 ABTECT Trials in Patients with Moderately to Severely Active Ulcerative Colitis
- The Phase 3 ABTECT trials (Studies 105 and 106) evaluating obefazimod in patients with moderately to severely active ulcerative colitis successfully enrolled 1,275 participants, exceeding the target enrollment of 1,224 by
4% . - Top-line results from the 8-week induction trials anticipated in Q3 2025, with 44-week maintenance data on track for Q2 2026 and, if successful, NDA submission planned for H2 2026.
- Blinded baseline characteristics align with pre-specified target population and are consistent with Phase 2b UC trial participant characteristics
- Cash runway through ABTECT induction trials readout and into Q4 2025
PARIS, France – April 29, 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 the completion of enrollment for the Phase 3 ABTECT trials in patients with moderately to severely active ulcerative colitis.
Marc de Garidel, Chief Executive Officer of Abivax, commented:
“Completing enrollment for our Phase 3 ABTECT trials—one of the largest and fastest enrolling ulcerative colitis programs of its kind ever conducted—is a landmark achievement for both Abivax and the UC patient community. Obefazimod has already shown compelling potential to address the significant unmet needs of patients with moderately to severely active disease. We remain fully committed to advancing this pivotal program: we expect to report top‑line induction results in Q3 2025, followed by comprehensive long‑term maintenance data in Q2 2026. Should these data confirm obefazimod’s safety and efficacy, we plan to submit a New Drug Application to the FDA in the second half of 2026, bringing us ever closer to delivering a desperately needed new therapeutic option.”
Fabio Cataldi, MD, Chief Medical Officer of Abivax added: "Importantly, the blinded baseline characteristics of participants in the Phase 3 ABTECT trials closely align with those observed in our Phase 2b trial. This consistency reinforces our confidence in obefazimod’s potential efficacy and safety profile as we advance through the pivotal stage of its clinical development."
Trial Participant Baseline Characteristics: ABTECT Phase 3 vs. Obefazimod Phase 2b
| ABTECT Phase 3 | Phase 2b | |
| Study Participants | 1,275 | 252 |
| Baseline MMS (7-9) | ||
| Prior Advanced Therapy Failure | ||
| Corticosteroids | ||
| Geographic Distribution | North America: Western / Central Europe: Eastern Europe: Asia: ROW: | North America: Western/Central Europe: Eastern Europe: |
ABTECT Phase 3 Trials Update:
- Enrollment Completion: 1,275 participants successfully enrolled into two Phase 3 pivotal studies across multiple clinical sites.
- Maintenance Study: To date, 597 of the 1,111 participants—comprising both completers of the induction study and those who were randomized but discontinued during the induction phase—have been enrolled in Part 1 (the 'responder arm') of the 44-week maintenance trial. This exceeds the minimum enrollment required to meet the statistical power assumptions. The Maintenance Study will continue to enroll participants through completion of induction study (end of June 2025).
- Top-Line Results: Induction trials topline data expected in Q3 2025, with 44-week maintenance topline data expected in Q2 2026.
- Participant Characteristics: Blinded baseline data aligns with the target population identified in the Phase 2b UC study.
- Safety Monitoring: No new safety signals observed in the latest Data Safety Monitoring Board (DSMB) review conducted on April 25, 2025.
- Regulatory Strategy: Pending positive results, a New Drug Application (NDA) submission in the US is targeted for H2 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 and financial objectives. 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 top-line data readout of its ABTECT clinical trials and NDA submission, the potential therapeutic benefit of obefazimod, and the Company’s expected cash runway. 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.
FAQ
When will Abivax (ABVX) release Phase 3 ABTECT trial results for ulcerative colitis?
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What are the safety findings from Abivax's (ABVX) latest DSMB review for obefazimod?
