Abivax Announces Positive Phase 3 Results from Both ABTECT 8-Week Induction Trials Investigating Obefazimod, its First-in-Class Oral miR-124 Enhancer, in Moderate to Severely Active Ulcerative Colitis
Abivax (NASDAQ:ABVX) announced positive Phase 3 results from its ABTECT-1 and ABTECT-2 trials evaluating obefazimod, a first-in-class oral miR-124 enhancer, for treating moderate to severe ulcerative colitis. The 50mg once-daily dose achieved a compelling pooled 16.4% placebo-adjusted clinical remission rate at Week 8.
Key highlights include: 19.3% placebo-adjusted remission in ABTECT-1 and 13.4% in ABTECT-2, meeting all primary and secondary endpoints. The trials involved 1,275 patients across 600 sites in 36 countries, with 47.3% having inadequate response to prior advanced therapy. The drug demonstrated favorable safety with no new safety signals.
The company plans to submit FDA and EMA applications in H2 2026, pending successful maintenance trial results expected in Q2 2026.
Abivax (NASDAQ:ABVX) ha annunciato risultati positivi di Fase 3 dai suoi studi ABTECT-1 e ABTECT-2 che valutano obefazimod, un potenziatore orale di miR-124 di prima classe, per il trattamento della colite ulcerosa da moderata a grave. La dose di 50 mg una volta al giorno ha raggiunto un convincente tasso di remissione clinica aggiustato per placebo del 16,4% alla settimana 8.
I punti salienti includono: 19,3% di remissione aggiustata per placebo in ABTECT-1 e 13,4% in ABTECT-2, con il raggiungimento di tutti gli endpoint primari e secondari. Gli studi hanno coinvolto 1.275 pazienti in 600 centri in 36 paesi, con il 47,3% che aveva una risposta insufficiente a terapie avanzate precedenti. Il farmaco ha mostrato un profilo di sicurezza favorevole senza nuovi segnali di sicurezza.
L'azienda prevede di presentare le domande alla FDA e all'EMA nella seconda metà del 2026, in attesa dei risultati positivi dello studio di mantenimento previsti per il secondo trimestre del 2026.
Abivax (NASDAQ:ABVX) anunció resultados positivos de la Fase 3 de sus ensayos ABTECT-1 y ABTECT-2 que evalúan obefazimod, un potenciador oral de miR-124 de primera clase, para el tratamiento de la colitis ulcerosa de moderada a grave. La dosis de 50 mg una vez al día logró una tasa de remisión clínica ajustada por placebo del 16,4% a las 8 semanas.
Los puntos clave incluyen: 19,3% de remisión ajustada por placebo en ABTECT-1 y 13,4% en ABTECT-2, cumpliendo con todos los objetivos primarios y secundarios. Los ensayos involucraron a 1.275 pacientes en 600 sitios en 36 países, con un 47,3% que mostró respuesta insuficiente a terapias avanzadas previas. El medicamento demostró un perfil de seguridad favorable sin nuevas señales de seguridad.
La compañía planea presentar solicitudes a la FDA y EMA en la segunda mitad de 2026, pendiente de resultados exitosos del ensayo de mantenimiento esperados para el segundo trimestre de 2026.
Abivax (NASDAQ:ABVX)는 중등도에서 중증 궤양성 대장염 치료를 위한 최초의 경구 miR-124 증강제인 오베파지모드의 ABTECT-1 및 ABTECT-2 3상 임상시험에서 긍정적인 결과를 발표했습니다. 50mg 1일 1회 용량은 8주차에 위약 대비 16.4%의 임상 관해율을 달성했습니다.
주요 내용으로는 ABTECT-1에서 위약 대비 19.3% 관해율, ABTECT-2에서 13.4%를 기록하며 모든 1차 및 2차 평가변수를 충족했습니다. 총 36개국 600개 기관에서 1,275명의 환자가 참여했으며, 47.3%는 이전 고급 치료에 불충분한 반응을 보였습니다. 약물은 새로운 안전성 문제 없이 우수한 안전성을 입증했습니다.
회사는 2026년 하반기에 FDA 및 EMA 신청을 계획하고 있으며, 2026년 2분기에 예상되는 유지 임상시험 결과 성공 여부에 따라 진행할 예정입니다.
Abivax (NASDAQ:ABVX) a annoncé des résultats positifs de phase 3 issus de ses essais ABTECT-1 et ABTECT-2 évaluant l'obefazimod, un amplificateur oral de miR-124 de première classe, pour le traitement de la colite ulcéreuse modérée à sévère. La dose quotidienne unique de 50 mg a atteint un taux de rémission clinique ajusté sur placebo de 16,4% à la semaine 8.
Les points clés incluent : 19,3% de rémission ajustée sur placebo dans ABTECT-1 et 13,4% dans ABTECT-2, atteignant tous les critères principaux et secondaires. Les essais ont impliqué 1 275 patients répartis sur 600 sites dans 36 pays, dont 47,3% présentaient une réponse insuffisante aux traitements avancés antérieurs. Le médicament a démontré une sécurité favorable sans nouveaux signaux de sécurité.
La société prévoit de soumettre les dossiers à la FDA et à l'EMA au second semestre 2026, sous réserve des résultats positifs de l'essai de maintien attendus au deuxième trimestre 2026.
Abivax (NASDAQ:ABVX) gab positive Phase-3-Ergebnisse aus den Studien ABTECT-1 und ABTECT-2 bekannt, in denen Obefazimod, ein neuartiger oraler miR-124-Enhancer, zur Behandlung von mittelschwerer bis schwerer Colitis ulcerosa untersucht wurde. Die einmal tägliche Dosis von 50 mg erreichte eine überzeugende poolspezifische klinische Remissionsrate von 16,4% gegenüber Placebo in Woche 8.
Wesentliche Highlights umfassen: 19,3% placebo-adjustierte Remission in ABTECT-1 und 13,4% in ABTECT-2, wobei alle primären und sekundären Endpunkte erfüllt wurden. Die Studien umfassten 1.275 Patienten an 600 Standorten in 36 Ländern, wobei 47,3% eine unzureichende Reaktion auf vorherige fortgeschrittene Therapien zeigten. Das Medikament zeigte ein günstiges Sicherheitsprofil ohne neue Sicherheitsbedenken.
Das Unternehmen plant die Einreichung bei der FDA und EMA in der zweiten Hälfte 2026, vorbehaltlich erfolgreicher Ergebnisse der Erhaltungsstudie, die für das zweite Quartal 2026 erwartet werden.
- Achieved statistically significant clinical remission rates in both Phase 3 trials
- Met all key secondary endpoints with clinically meaningful benefits
- Demonstrated favorable safety profile with no new safety signals
- Strong enrollment of 678 patients into maintenance trial
- Largest Phase 3 UC trial population with prior JAK inhibitor exposure
- 25mg dose failed to achieve statistical significance in ABTECT-2 trial
- Maintenance trial results not expected until Q2 2026
- Higher rate of treatment-emergent adverse events in 50mg groups (59.4% and 61.0%) vs placebo
Insights
Abivax's obefazimod shows compelling efficacy in Phase 3 ulcerative colitis trials with strong safety profile, positioning it as a potential first-in-class therapy.
The results from Abivax's ABTECT-1 and ABTECT-2 trials demonstrate robust efficacy for obefazimod in moderate-to-severe ulcerative colitis (UC). The 50mg dose achieved an impressive pooled placebo-adjusted clinical remission rate of 16.4% (p<0.0001) at Week 8, with individual trial rates of 19.3% and 13.4% respectively - both highly statistically significant.
What's particularly notable is that this novel oral miR-124 enhancer succeeded in a challenging patient population - 47.3% had inadequate response to prior advanced therapies, including the largest population of JAK inhibitor failures in any Phase 3 UC program to date. This suggests potential efficacy in treatment-refractory patients where options are limited.
The favorable safety profile is equally compelling. Treatment-emergent adverse events leading to discontinuation were low (0-5.3%) and comparable to placebo. Serious adverse events were similarly balanced, with very few serious infections reported. This clean safety profile distinguishes obefazimod from some existing UC therapies known for significant safety concerns.
The study's design is robust with 1,275 patients across 600+ sites in 36 countries, making it one of the largest Phase 3 UC programs ever conducted. This scale, combined with the inclusion of both biologic-naïve and experienced patients, strengthens the generalizability of these findings.
The mechanism as a first-in-class miR-124 enhancer represents a novel approach to treating inflammatory bowel disease by targeting an entirely different pathway than existing therapies. With maintenance results expected in Q2 2026 and regulatory submissions planned for H2 2026, obefazimod could potentially address significant unmet needs in UC management, particularly as an oral therapy with efficacy comparable to injectable biologics but with a more favorable safety profile.
Abivax Announces Positive Phase 3 Results from Both ABTECT 8-Week Induction Trials Investigating Obefazimod, its First-in-Class Oral miR-124 Enhancer, in Moderate to Severely Active Ulcerative Colitis
- 50 mg once-daily dose of obefazimod led to a compelling pooled
16.4% (p<0.0001) placebo-adjusted clinical remission rate at Week 8 in the ABTECT-1 (Study 105) and ABTECT-2 (Study 106) trials. Individually, the 50 mg dose demonstrated a placebo-adjusted remission rate of19.3% (p<0.0001) in ABTECT-1 and a placebo-adjusted remission rate of13.4% (p=0.0001) in ABTECT-2. - 50 mg once-daily dose of obefazimod met all key secondary endpoints demonstrating highly statistically significant and clinically meaningful benefits.
- ABTECT included a well-balanced distribution of advanced therapy naïve and advanced therapy experienced participants, with
47.3% of participants having had inadequate response to prior advanced therapy, including the largest population of patients with inadequate response to JAK inhibitor therapy in Phase 3 UC trials to date. - Obefazimod demonstrated favorable tolerability results, with no new safety signals observed. The treatment was generally well tolerated across both dose groups.
- The ABTECT Maintenance Trial (ABX464-107) is ongoing with top-line results expected to report out in Q2 2026. Among the 1,275 patients randomized in the induction trials, 678 achieved clinical response and enrolled into part 1 of the maintenance trial. The ABTECT program is one of the largest Phase 3 ulcerative colitis trials ever conducted.
- Abivax to host a conference call and webcast today at 4:30 p.m. EDT (10:30 p.m. CEST) to discuss the results.
PARIS, France – July 22, 2025 – 10:05 PM CEST – 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 positive topline results from its Phase 3 ABTECT-1 (Study 105) and ABTECT-2 (Study 106) 8-week induction trials evaluating its oral, first-in-class miR-124 enhancer, obefazimod (ABX464), in adult patients with moderately to severely active ulcerative colitis (“UC”).
Marc de Garidel, Chief Executive Officer of Abivax, commented: “Today marks a significant milestone for Abivax, and more importantly, for the ulcerative colitis community. The strength of these results reinforces our belief in obefazimod, our first-in-class miR-124 enhancer, and its potential to become a transformative new treatment modality for patients with UC. Pending successful results from the 44-week maintenance trial, we are preparing to submit a New Drug Application to the FDA in the second half of 2026. We would like to thank the patients who participated in the trials as well as the investigators and staff at over 600 sites in 36 countries who contributed to the landmark trials.”
David Rubin, M.D., Chief, Section of Gastroenterology, Hepatology and Nutrition, and Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, commented: “The results of the two induction studies for this first-in-class therapy for ulcerative colitis are both statistically significant and clinically meaningful. Based on the impressive safety and tolerability profile demonstrated to date, and pending similar results in the maintenance study, obefazimod will offer a welcome new option for those who suffer from ulcerative colitis, both as an attractive early option as well as for those who have had inadequate response or loss of response to prior advanced therapies.”
Topline Results
The ABTECT-1 and ABTECT-2 induction trials are global, multicenter, randomized, double-blind, placebo-controlled trials assessing once-daily oral administration of obefazimod at 25 mg or 50 mg doses in adult patients with moderately to severely active UC. Eligible participants had inadequate response, loss of response, or intolerance to conventional and/or advanced therapies. ABTECT-1 and ABTECT-2 were conducted simultaneously and have enrolled 1,275 patients from over 600 participating clinical trial sites in 36 countries with the intent to satisfy regulatory requirements globally. The ABTECT Program is one of the largest Phase 3 ulcerative colitis trials ever conducted and includes the largest population of patients with inadequate response to JAK inhibitor therapy.
| FDA Primary Endpoint and Key Secondary Endpoints | ||||||
| ABTECT-1 (Study 105) | ABTECT-2 (Study 106) | |||||
| Placebo (N=158) | 25 mg (N=160) | 50 mg (N=318) | Placebo (N=159) | 25 mg (N=159) | 50 mg (N=318) | |
| Clinical Remission | ||||||
| Week 8 - n (%) | 4 ( | 38 ( | 69 ( | 10 ( | 18 ( | 63 ( |
| P value | <0.0001 | <0.0001 | 0.1034 | 0.0001 | ||
| Placebo-Adjusted ∆ | ∆ | ∆ | ∆ | ∆ | ||
| Endoscopic Improvement | ||||||
| Week 8 - n (%) | 9 ( | 60 ( | 106 ( | 16 ( | 35 ( | 113 ( |
| P value | <0.0001 | <0.0001 | 0.0029 | <0.0001 | ||
| Clinical Response | ||||||
| Week 8 - n (%) | 45 ( | 105 ( | 194 ( | 53 ( | 85 ( | 201 ( |
| P value | <0.0001 | <0.0001 | 0.0002 | <0.0001 | ||
| HEMI1 | ||||||
| Week 8 - n (%) | 5 ( | 38 ( | 73 ( | 12 ( | 21 ( | 76 ( |
| P value | <0.0001 | <0.0001 | 0.0932 | <0.0001 | ||
Results from the ABTECT-1 and ABTECT-2 trials demonstrated that obefazimod met its FDA primary endpoint of clinical remission at Week 8 in the 50 mg once-daily dose regimens for both trials. Individually, ABTECT-1 showed a placebo-adjusted clinical remission rate of
The 25 mg once-daily dose of obefazimod achieved the FDA primary endpoint of clinical remission at Week 8 in ABTECT-1 demonstrating a placebo-adjusted remission rate of
The safety profile of obefazimod remained consistent with prior clinical experience. No new safety signals were observed in either trial and the treatment was generally well tolerated across both dose groups.
| Summary of Adverse Events | ||||||
| ABTECT-1 (Study 105) | ABTECT-2 (Study 106) | |||||
| Placebo (N=158) | 25 mg (N=160) | 50 mg (N=318) | Placebo (N=159) | 25 mg (N=159) | 50 mg (N=318) | |
| TEAE2, n (%) | ||||||
| Any TEAE | 84 ( | 75 ( | 189 ( | 77 ( | 81 ( | 194 ( |
| TEAE leading to study drug discontinuation | 6 ( | 0 ( | 17 ( | 9 ( | 8 ( | 15 ( |
| Serious TEAE | 3 ( | 1 ( | 14 ( | 7 ( | 6 ( | 6 ( |
| Malignancy | 0 ( | 0 ( | 1 ( | 0 ( | 0 ( | 0 ( |
| Serious/severe (grade ≥3) infections and opportunistic infections | 1 ( | 1 ( | 2 ( | 0 ( | 0 ( | 2 ( |
Ongoing ABTECT Phase 3 Maintenance Trial:
- Maintenance Trial: 678 of 1,275 participants entered Part 1, the responder cohort.
- Topline maintenance results are expected in Q2 2026, which are intended to support regulatory filings globally.
- Regulatory Strategy: Contingent on positive 44-week maintenance results, Abivax intends to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (“MAA”) to the European Medicines Agency (EMA) in the second half of 2026.
Fabio Cataldi, M.D. Chief Medical Officer, stated: "The exemplary results from the ABTECT induction trials reflect our dedication to scientific rigor and disciplined execution. We are thrilled to report outcomes that not only met but exceeded the bar set by our Phase 2b trial, a remarkable achievement that speaks volumes about the quality of our development program. We look forward to presenting more detailed analysis, including patients with inadequate response to prior JAK therapy at an upcoming medical conference."
Please note that the Company will be postponing reporting H1 2025 financial results that were originally scheduled for August 11, 2025 to September 8, 2025. Preliminary cash and cash equivalents as of June 30, 2025, were approximately
Investor Conference Call and Webcast
Abivax management will host an investor and analyst conference call today at
4:30 p.m. EDT / 10:30 p.m. CEST to discuss the topline results. To participate, please use the following dial-in or webcast link:
https://register-conf.media-server.com/register/BI48058afba0d840b4b027a59daa065dd8
About the ABTECT Ulcerative Colitis Program
The global obefazimod ulcerative colitis program evaluates more than 1,200 patients with moderately to severely active ulcerative colitis across three pivotal trials. These studies include assessments of efficacy and safety of obefazimod. More information on these trials can be found at www.clinicaltrials.gov (NCT05507203, NCT05507216, NCT05535946).
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 NDA and MAA submissions, the potential therapeutic benefit of obefazimod and the timing of release of its half-year 2025 financials. 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.
1HEMI = Histological Endoscopic Mucosal Improvement
2 TEAE = Treatment Emergent Adverse Events; The final safety database lock will not occur until August 2025, but is more than
¥ Bronchopulmonary aspergillosis; ‡ Appendicitis; δ Anal abscess, pneumonia
3 The preliminary cash and cash equivalents as of June 30, 2025 is unaudited and subject to adjustment related to quarterly closing procedures and could differ from the Company’s announcement of complete financial results for H1 2025. Accordingly, you should not place undue reliance on these preliminary estimates.
FAQ
What were the key results of Abivax's Phase 3 ABTECT trials for obefazimod?
How many patients participated in the ABVX ABTECT Phase 3 trials?
What was the safety profile of obefazimod in the ABVX Phase 3 trials?
When does Abivax (ABVX) plan to submit regulatory applications for obefazimod?
What is unique about obefazimod's mechanism of action for ulcerative colitis?
