Abivax Achieves Key Milestone in Phase 3 ABTECT Trial Enrollment
Abivax (ABVX) has reached a significant milestone in its Phase 3 ABTECT trial for obefazimod, enrolling 1,003 out of 1,224 targeted participants (82%) for treating moderately to severely active ulcerative colitis. The company expects to complete enrollment in Q2 2025, with top-line results for the 8-week induction trial anticipated in Q3 2025.
The 44-week maintenance data is expected in Q2 2026, followed by NDA submission in H2 2026 if successful. The blinded baseline characteristics align with the pre-specified target population and are consistent with the Phase 2b UC trial. The company confirms its cash runway extends through the ABTECT induction trial readout and into Q4 2025, with no additional financing needed.
The trial's safety profile shows no new safety signals under the oversight of the independent Data Monitoring Committee. Obefazimod is being developed as a potentially first-in-class oral treatment option for UC patients.
Abivax (ABVX) ha raggiunto un traguardo importante nel suo studio di Fase 3 ABTECT per obefazimod, arruolando 1.003 partecipanti su 1.224 previsti (82%) per il trattamento della colite ulcerosa attiva moderata-severa. L'azienda si aspetta di completare l'arruolamento nel secondo trimestre del 2025, con i risultati preliminari per lo studio di induzione di 8 settimane previsti nel terzo trimestre del 2025.
I dati di mantenimento di 44 settimane sono attesi nel secondo trimestre del 2026, seguiti dalla presentazione della NDA nel secondo semestre del 2026, se avrà successo. Le caratteristiche di base, in cieco, sono in linea con la popolazione target predefinita e sono coerenti con lo studio di Fase 2b sulla colite ulcerosa. L'azienda conferma che il suo capitale è sufficiente fino alla lettura dei risultati dello studio di induzione ABTECT e fino al quarto trimestre del 2025, senza necessità di ulteriore finanziamento.
Il profilo di sicurezza dello studio non mostra nuovi segnali di sicurezza sotto la supervisione del Comitato Indipendente di Monitoraggio dei Dati. Obefazimod viene sviluppato come un'opzione di trattamento orale potenzialmente innovativa per i pazienti con colite ulcerosa.
Abivax (ABVX) ha alcanzado un hito significativo en su ensayo de Fase 3 ABTECT para obefazimod, inscribiendo a 1,003 de los 1,224 participantes previstos (82%) para el tratamiento de la colitis ulcerosa activa moderada a severa. La compañía espera completar la inscripción en el segundo trimestre de 2025, con resultados preliminares del ensayo de inducción de 8 semanas anticipados para el tercer trimestre de 2025.
Se esperan los datos de mantenimiento de 44 semanas en el segundo trimestre de 2026, seguidos de la presentación de la NDA en la segunda mitad de 2026 si tiene éxito. Las características iniciales ciegas están alineadas con la población objetivo preespecificada y son consistentes con el ensayo de Fase 2b para UC. La compañía confirma que su capital es suficiente hasta la lectura de los resultados del ensayo de inducción ABTECT y hasta el cuarto trimestre de 2025, sin necesidad de financiamiento adicional.
El perfil de seguridad del ensayo no muestra nuevas señales de seguridad bajo la supervisión del Comité Independiente de Monitoreo de Datos. Obefazimod se está desarrollando como una opción de tratamiento oral potencialmente innovadora para pacientes con UC.
Abivax (ABVX)는 활성 중등도에서 중증 궤양성 대장염 치료를 위한 obefazimod의 3상 ABTECT 임상시험에서 1,224명의 목표 참여자 중 1,003명을 등록하여(82%) 중요한 이정표에 도달했습니다. 회사는 2025년 2분기까지 등록을 완료할 것으로 예상하며, 8주 유도 시험의 최종 결과는 2025년 3분기에 발표될 것으로 보입니다.
44주 유지 데이터는 2026년 2분기에 예상되며, 성공적으로 진행될 경우 2026년 하반기에 NDA 제출이 예정되어 있습니다. 블라인드 기준 특성은 미리 설정된 목표 모집단과 일치하며 2b상 UC 시험과 일관성이 있습니다. 회사는 자금이 ABTECT 유도 시험 결과 발표 시점까지 지속되며 2025년 4분기까지 필요한 추가 자금 조달이 없음을 확인합니다.
시험의 안전성 프로필은 독립 데이터 모니터링 위원회의 감독 하에 새로운 안전 신호가 없음을 보여줍니다. Obefazimod는 UC 환자를 위한 잠재적인 최초의 경구 치료 옵션으로 개발되고 있습니다.
Abivax (ABVX) a atteint une étape significative dans son essai de Phase 3 ABTECT pour obefazimod, en inscrivant 1 003 des 1 224 participants ciblés (82%) pour le traitement de la colite ulcéreuse modérée à sévère. La société prévoit de terminer l'inscription au 2ème trimestre 2025, avec des résultats préliminaires pour l'essai d'induction de 8 semaines attendus au 3ème trimestre 2025.
Les données de maintenance sur 44 semaines sont attendues au 2ème trimestre 2026, suivies de la soumission de la NDA au 2ème semestre 2026 si tout se passe bien. Les caractéristiques de base en aveugle correspondent à la population cible prédéfinie et sont cohérentes avec l'essai UC de Phase 2b. L'entreprise confirme que sa liquidité s'étend jusqu'à la lecture des résultats de l'étude d'induction ABTECT et dans le 4ème trimestre 2025, sans besoin de financement supplémentaire.
Le profil de sécurité de l'essai ne montre aucun nouveau signal de sécurité sous la supervision du Comité Indépendant de Surveillance des Données. Obefazimod est en cours de développement en tant qu'option de traitement orale potentiellement innovante pour les patients atteints de colite ulcéreuse.
Abivax (ABVX) hat einen bedeutenden Meilenstein in seiner Phase-3-Studie ABTECT für Obefazimod erreicht und 1.003 von 1.224 angestrebten Teilnehmern (82%) zur Behandlung von mäßig bis schwer aktiver Colitis ulcerosa eingeschlossen. Das Unternehmen erwartet, die Einschreibung im 2. Quartal 2025 abzuschließen, wobei die vorläufigen Ergebnisse der 8-wöchigen Induktionsstudie im 3. Quartal 2025 erwartet werden.
Die Daten zur 44-wöchigen Erhaltungstherapie werden für das 2. Quartal 2026 erwartet, gefolgt von der NDA-Einreichung im 2. Halbjahr 2026, falls erfolgreich. Die blinden Basismerkmale stimmen mit der vordefinierten Zielpopulation überein und sind konsistent mit der Phase-2b-UC-Studie. Das Unternehmen bestätigt, dass es genügend Kapital hat, um die Ergebnisse der ABTECT-Induktionsstudie bis ins 4. Quartal 2025 finanzieren zu können, ohne dass zusätzliche Finanzierungen nötig sind.
Das Sicherheitsprofil der Studie zeigt unter der Aufsicht des unabhängigen Datenüberwachungsausschusses keine neuen Sicherheitszeichen. Obefazimod wird als potenzielle erstmalige orale Behandlungsmöglichkeit für UC-Patienten entwickelt.
- 82% enrollment completion (1,003 of 1,224 participants) in Phase 3 ABTECT trial
- Sufficient cash runway through Q4 2025 with no additional financing needed
- No new safety signals observed in the trial
- Baseline characteristics align with Phase 2b trial expectations
- Enrollment completion delayed to Q2 2025 due to UC trial recruitment competition
- Top-line results timeline pushed to Q3 2025
Insights
The Phase 3 ABTECT trial's 82% enrollment completion with 1,003 participants represents a important advancement in obefazimod's development pathway. The trial's rapid enrollment pace, despite intense competition in UC trials, suggests strong investigator confidence and patient interest. The balanced recruitment strategy between bio-naïve and bio-experienced patients enhances the study's potential real-world applicability.
The trial design demonstrates robust scientific methodology, with the 8-week induction period followed by a 44-week maintenance phase allowing comprehensive efficacy assessment. The alignment of blinded baseline characteristics with Phase 2b data strengthens internal validity and increases confidence in potential outcome reproducibility. The absence of new safety signals under DMC oversight is particularly encouraging for this novel oral therapeutic approach.
This milestone carries significant market implications. The confirmed cash runway extending through Q4 2025 provides important operational flexibility and de-risks the path to top-line data readout. The strategic timing of anticipated NDA submission in H2 2026 positions ABVX to potentially capture share in the
The trial's progression timeline, particularly the Q3 2025 readout, creates a clear catalyst pathway for potential value creation. The company's market cap of
Obefazimod's development as a first-in-class oral treatment for UC represents a potential paradigm shift in treatment options. The current standard of care often relies on biologics, creating a substantial market opportunity for an effective oral alternative. The large trial size of 1,224 participants provides robust statistical power to demonstrate efficacy.
The dual-phase trial design (8-week induction + 44-week maintenance) aligns with regulatory requirements and enables comprehensive safety and efficacy evaluation. The balanced recruitment strategy between treatment-naïve and experienced patients will provide valuable insights into obefazimod's potential positioning in the treatment algorithm. The maintained safety profile at this advanced stage of development is particularly encouraging for chronic inflammatory disease therapeutics.
Abivax Achieves Key Milestone in Phase 3 ABTECT Trial Enrollment
- Phase 3 ABTECT Trial evaluating obefazimod for moderately to severely active ulcerative colitis (“UC”) reaches 1,003 of 1,224 participants, representing
82% of target enrollment. Enrollment completion expected in Q2 2025. - Top-line results for the 8-week induction trial 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 consistent with Phase 2b UC trial
- Cash runway through ABTECT induction trial readout and into Q4 2025
PARIS, France – January 9, 2025 – 5:35 PM CET – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company developing innovative therapies to address chronic inflammatory diseases, today announced a significant milestone in the Phase 3 ABTECT clinical trial evaluating obefazimod for the treatment of moderately to severely active UC.
Marc de Garidel, Chief Executive Officer of Abivax, commented: “We are thrilled to announce that the ABTECT Phase 3 trial has reached a significant milestone, with over 1,000 participants enrolled, representing
Mr. de Garidel went on to say, “In order to ensure a balanced representation of bio-naïve and bio-experienced participants amid heightened competition in UC trial recruitment, we now anticipate completing enrollment in Q2 2025 and delivering top-line results for the 8-week induction trial in Q3 2025. With the ABTECT trial, we aim to validate the value of obefazimod as a potentially first-in-class safe and effective oral treatment option, which remains a significant unmet need for patients with UC.”
Looking Ahead to 2025
With Phase 3 enrollment nearing completion and key data readouts on the horizon, the Company believes 2025 is shaping up to be a pivotal year. Beyond the ABTECT trial, the Company is advancing its broader portfolio to address chronic inflammatory conditions that affect millions worldwide.
Didier Blondel, Chief Financial Officer of Abivax, added: “Without the need for additional financing, our cash runway extends beyond the expected top-line results from the ABTECT induction trial and into Q4 2025, ensuring we remain well-positioned to execute our strategy.”
ABTECT Phase 3 Update
- Enrollment Progress: 1,003 of the targeted 1,224 participants enrolled to date.
- Top-Line Results: Induction trial results expected in Q3 2025, with 44-week maintenance data to follow in Q2 2026.
- Regulatory Pathway: NDA submission planned for H2 2026, assuming positive clinical data.
- Participant Characteristics: Blinded baseline data aligns with the target population defined during Phase 2b.
- Safety Profile: No new safety signals observed to date with the oversight of the independent Data Monitoring Committee.
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 expectations for 2025 and 2026, including anticipated timing for top-line data readout of its ABTECT clinical trials and NDA submission, 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 April 5, 2024 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
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