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Abivax (NASDAQ:ABVX) announced late-breaking results from the Phase 3 ABTECT 8-week induction trials for obefazimod presented Oct 5, 2025 at UEG. The PR states the pooled 50 mg once-daily dose produced a 16.4% placebo-adjusted clinical remission rate at Week 8 (p and that both ABTECT 1 and 2 met the FDA primary endpoint and all key secondary endpoints at 50 mg.
The trials enrolled 1,272 patients with a refractory population (47% with prior inadequate response to advanced therapy; 21% with prior JAK inhibitor inadequate response). The PR reports no signal for serious, severe, or opportunistic infections or malignancies and provides updated TEAE rates by dose.
Abivax (NASDAQ:ABVX) ha annunciato risultati di ultima ora dai trial di induzione di 8 settimane di fase 3 ABTECT per obefazimod presentati il 5 ottobre 2025 a UEG. Il comunicato stampa afferma che la dose combinata di 50 mg una volta al giorno ha prodotto un tasso di remissione clinica aggiustato per placebo del 16,4% all’8ª settimana (p e che sia ABTECT 1 sia ABTECT 2 hanno raggiunto l’obiettivo primario della FDA e tutti i principali endpoint secondari a 50 mg.
Gli studi hanno arruolato 1.272 pazienti con una popolazione refrattaria (47% con risposte inadeguate a terapie avanzate precedenti; 21% con risposta inadeguata a inibitore JAK precedente). Il comunicato riporta nessun segnale di infezioni gravi, severe o opportunistiche o malignità e fornisce tassi TEAE aggiornati per dose.
Abivax (NASDAQ:ABVX) anunció resultados de última hora de los ensayos de inducción de 8 semanas de la fase 3 ABTECT para obefazimod presentados el 5 de octubre de 2025 en UEG. El comunicado de prensa indica que la dosis combinada de 50 mg una vez al día produjo una tasa de remisión clínica ajustada por placebo del 16,4% en la Semana 8 (p y que tanto ABTECT 1 como ABTECT 2 cumplieron el objetivo primario de la FDA y todos los principales endpoints secundarios a 50 mg.
Los ensayos incluyeron 1.272 pacientes con una población refractaria (47% con respuesta inadecuada previa a terapias avanzadas; 21% con respuesta inadecuada a inhibidor de JAK previo). El comunicado informa que no hay señal de infecciones graves, severas u oportunistas o de malignidades y ofrece tasas actualizadas de TEAE por dosis.
Abivax (NASDAQ:ABVX)는 OBefazimod의 8주 발현 단계 3상 ABTECT의 깨달음 결과를 2025년 10월 5일 UEG에서 발표했습니다. 보도자료에 따르면 50 mg 1일 1회 복용 용량이 8주 차에 무작위 대조군 대비 임상 관해율 16.4% (p을 산출했고, ABTECT 1과 2 모두 50 mg에서 FDA 주요 1차 평가점수 및 모든 주요 보조 평가점수를 충족했습니다.
임상시험은 1,272명의 환자를 모집했으며 난치성 인구(전 신약 치료에 대한 반응 불량 47%; 이전 JAK 억제제에 대한 반응 불량 21%)를 포함했습니다. 보도자료는 중대한 감염, 심각한 감염 또는 기회감염, 악성 종양 신호가 없다고 보고하며 용량별 TEAE 비율을 업데이트합니다.
Abivax (NASDAQ:ABVX) a annoncé des résultats de dernière minute des essais d’induction de phase 3 ABTECT sur 8 semaines pour l’obefazimod présentés le 5 octobre 2025 à l’UEG. Le communiqué précise que la dose combinée de 50 mg une fois par jour a produit un taux de rémission clinique ajusté sur placebo de 16,4% à la semaine 8 (p et que ABTECT 1 et 2 ont atteint l’objectif principal de la FDA et tous les principaux critères secondaires à 50 mg.
Les essais ont recruté 1 272 patients dans une population réfractaire (47% avec une réponse insuffisante à un traitement avancé antérieur; 21% avec une réponse insuffisante à un inhibiteur JAK antérieur). Le communiqué indique qu’aucun signal d’infections graves, sévères ou opportunistes ou de malignités n’est présent et fournit des taux TEAE mis à jour par dose.
Abivax (NASDAQ:ABVX) kündigte späte Ergebnisse aus den Phase-3-8-Wochen-Induktionsstudien ABTECT für Obefazimod an, vorgestellt am 5. Oktober 2025 bei der UEG. Die Pressemitteilung besagt, dass die 50 mg-Dosis einmal täglich eine um 16,4 % imputationsbereinigte klinische Remissionsrate in Woche 8 (p produzierte und dass sowohl ABTECT 1 als auch ABTECT 2 das primäre Endziel der FDA und alle wichtigen sekundären Endpunkte bei 50 mg erreicht haben.
Die Studien rekrutierten 1.272 Patienten mit einer refraktären Population (47% mit vorheriger unzureichender Reaktion auf fortgeschrittene Therapie; 21% mit vorheriger unzureichender Reaktion auf JAK-Hemmer). Die Pressemitteilung berichtet keinen Hinweis auf schwere, schwere oder opportunistische Infektionen oder Malignitäten und liefert aktualisierte TEAE-Raten nach Dosis.
Abivax (NASDAQ:ABVX) أعلنت نتائج عاجلة من تجارب التهيئة من المرحلة الثالثة ABTECT لمدة 8 أسابيع لأوبيفازيمود المقدمة في 5 أكتوبر 2025 في UEG. تنص البيانات الصحفية على أن جرعة 50 مجم مرة يوميًا أنتجت معدل انعدام الأعراض السريرية المعدل بالدواء الوهمي 16.4% في الأسبوع 8 (p وأن كلا ABTECT 1 و ABTECT 2 حققا الهدف الأساسي لإدارة الغذاء والدواء FDA وجميع الأهداف الثانوية الرئيسية عند 50 مجم.
شملت التجارب 1,272 مريضا من فئة مقاومة (47% مع استجابة غير كافية لعلاج متقدم سابق؛ 21% مع استجابة غير كافية لمثبط JAK سابق). التقرير الصحفي يشير إلى أنه لا يوجد إشارة لعدوى خطيرة أو شديدة أو عدوى انتهازية أو أورام ويقدم معدلات TEAE المحدثة حسب الجرعة.
Abivax (NASDAQ:ABVX) 公布了来自第3阶段 ABTECT 的8周诱导试验的最新结果，针对 obefazimod 的结果于2025年10月5日在UEG发表。新闻稿称，50 mg 一日一次的联合剂量在第8周产生了一个相对于安慰剂的临床缓解率为16.4%（p，且 ABTECT 1 和 2 均在50 mg下达到了 FDA 的主要终点和所有关键次要终点。
试验共入组 1,272 例患者，包含难治性人群（47% 对高阶治疗前无效反应；21% 对先前 JAK 抑制剂无效反应）。新闻稿表示没有对严重、严重感染或机会性感染或恶性肿瘤的信号，并按剂量提供 TEAE 率的更新。
Positive
- Pooled clinical remission +16.4% placebo-adjusted at Week 8 (50 mg)
- ABTECT-1 placebo-adjusted remission 19.3% (p
- ABTECT-2 placebo-adjusted remission 13.4% (p=0.0001)
- Large refractory cohort enrolled: 1,272 patients; 47% prior advanced-therapy failure
- No signal for serious/severe/opportunistic infections or malignancies (pooled)
Negative
- Headache rates increased with dose: 6% placebo, 16% (25 mg), 24.1% (50 mg)
- Nausea rates: 1.3% placebo, 5.0% (25 mg), 7.2% (50 mg)
- Study discontinuation for headache
Insights
Positive Phase 3 induction results: obefazimod 50mg met primary and all key secondary endpoints at Week 8 in refractory UC.
The article states a pooled placebo-adjusted clinical remission of 16.4% (p at Week 8 for the 50 mg once-daily dose and individual trial effects of 19.3% (ABTECT-1) and 13.4% (ABTECT-2).
What it means: meeting the FDA primary endpoint in both trials in a population with high prior advanced-therapy failure (47% overall; 21% prior JAK failure) shows the drug produced a measurable induction benefit in a difficult-to-treat cohort. Why it matters: regulators and clinicians weigh consistent, statistically significant induction effects in refractory patients more heavily; this result strengthens the clinical case for obefazimod as an oral option for induction therapy.
Monitorable item: management will host a conference call on October 6, 2025 to discuss both late-breaking abstracts.
Safety profile appears acceptable at Week 8 with no new serious infection, opportunistic infection, or malignancy signals reported.
The press release reports no signal for serious, severe, or opportunistic infections or malignancies across 1,272 enrolled patients and lists the most common TEAEs: headache (6% placebo, 16% at 25mg, 24.1% at 50mg) and nausea (1.3% placebo, 5.0% at 25mg, 7.2% at 50mg), with discontinuations 1.1% at 50mg.
What it means: early safety signals reported are tolerable for an induction study and show low discontinuation rates; absence of opportunistic infections or malignancy through Week 8 is favorable but limited to short-term data. Why it matters: induction safety supports further regulatory review, but longer-term maintenance and larger exposure data remain necessary to fully assess risk.
10/05/2025 – 11:00 AM
Abivax Announces Positive Phase 3 Results for Obefazimod in Ulcerative Colitis, Shares Surge
Paris, France – October 5, 2025 – Abivax SA (NASDAQ:ABVX) today announced promising results from its Phase 3 ABTECT induction trials evaluating obefazimod as a treatment for moderate-to-severely active ulcerative colitis. The data, presented at the United European Gastroenterology (UEG) Meeting in Berlin, sent Abivax shares soaring as investors reacted to the drug’s efficacy and safety profile in a challenging patient population.
The ABTECT trials enrolled 1,272 patients, a significant portion of whom (47%) had previously failed advanced therapies, including 21% who had an inadequate response to JAK inhibitors. This refractory patient cohort underscores the unmet need for novel therapeutic options in ulcerative colitis.
According to the company’s press release, a pooled analysis of the data showed that a 50mg once-daily dose of obefazimod achieved a 16.4% placebo-adjusted clinical remission rate at Week 8 (pObefazimod also demonstrated a statistically significant benefit on key secondary endpoints. Breaking down the results by trial, ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% (p=0.00003) and ABTECT-2 showed a 13.4% rate (p=0.0001), both at the 50mg dose.
In terms of safety, the company reported no new signals for serious, severe, or opportunistic infections or malignancies in the pooled data. The most common treatment-emergent adverse events (TEAEs) were headache (placebo: 6%, 25mg: 16%, 50mg: 24.1%) and nausea (placebo: 1.3%, 25mg: 5.0%, 50mg: 7.2%). Discontinuation rates due to headache were low, at 1.1% in the 50mg group.
Analysts’ Take
Early reactions from analysts appear positive, noting that the drug’s efficacy in a difficult-to-treat patient group could position obefazimod favorably in the ulcerative colitis market. The absence of significant safety concerns is also viewed as a key differentiator.
However, some analysts caution that the headache and nausea rates at the 50mg dose could potentially impact patient compliance. Further data from longer-term maintenance studies will be crucial to fully assess the risk-benefit profile of obefazimod.
What’s Next?
Abivax is scheduled to present a second late-breaking abstract on October 6th. This information may provide more insights into the molecular mechanisms of obefazimod and its potential long-term benefits. Management will host a conference call to discuss the results of the presentations at 9 am ET/3 pm CET on October 6th.
“The results from the ABTECT trials are encouraging and suggest that obefazimod could become an important new treatment option for ulcerative colitis, particularly in patients who have failed other therapies,” said one analyst. “However, it remains to be seen how the drug will perform in the long-term and whether the tolerability issues can be effectively managed.”
FAQ
What Week 8 clinical remission did Abivax report for obefazimod 50 mg in ABVX trials?
The PR states a pooled 16.4% placebo-adjusted clinical remission at Week 8 for the 50 mg once-daily dose (p
Did ABTECT-1 and ABTECT-2 (ABVX) meet primary endpoints and key secondaries?
According to the company, both ABTECT-1 and ABTECT-2 met the FDA primary endpoint and all key secondary endpoints at 50 mg.
How many patients were enrolled across ABTECT 1 & 2 and how refractory was the population?
The PR reports 1,272 patients enrolled with 47% having prior inadequate response to advanced therapy and 21% prior inadequate response to JAK inhibitors.
What safety signals did Abivax report for obefazimod in the ABTECT pooled data?
The company reports no signal for serious, severe, or opportunistic infections or malignancies and lists TEAEs by dose (e.g., headache 24.1% at 50 mg).
When will Abivax discuss the late-breaking ABTECT results and how can investors listen?
Abivax will host a conference call on October 6, 2025 at 9:00 a.m. ET / 3:00 p.m. CET with a webcast link provided in the PR.
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