Abivax Announces First Patient Enrolled in ENHANCE-CD, the Phase 2b Trial of Obefazimod in Crohn’s Disease
Abivax has announced the enrollment of the first patient in its Phase 2b ENHANCE-CD trial for obefazimod in Crohn's disease. The trial aims to evaluate the efficacy and safety of obefazimod, an oral, once-daily treatment, in adults with moderately to severely active Crohn's disease. The study is designed as a multicenter, double-blind, randomized, placebo-controlled trial.
The trial consists of three phases: a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. It will assess obefazimod's performance compared to placebo in patients who have shown inadequate response to conventional and/or advanced therapies. The primary objective of the Extension Phase is to evaluate the long-term safety and tolerability of obefazimod.
Abivax ha annunciato l'arruolamento del primo paziente nel suo trial di fase 2b ENHANCE-CD per obefazimod nella malattia di Crohn. L'obiettivo del trial è valutare l'efficacia e la sicurezza di obefazimod, un trattamento orale da assumere una volta al giorno, in adulti con una malattia di Crohn moderatamente o gravemente attiva. Lo studio è progettato come un trial multicentrico, in doppio cieco, randomizzato e controllato con placebo.
Il trial è composto da tre fasi: una fase di induzione di 12 settimane, una fase di mantenimento di 40 settimane e una fase di estensione di 48 settimane. Sarà valutata la performance di obefazimod rispetto al placebo in pazienti che hanno mostrato una risposta inadeguata a terapie convenzionali e/o avanzate. L'obiettivo principale della fase di estensione è valutare la sicurezza e la tollerabilità a lungo termine di obefazimod.
Abivax ha anunciado la inclusión del primer paciente en su ensayo de fase 2b ENHANCE-CD para obefazimod en la enfermedad de Crohn. El ensayo tiene como objetivo evaluar la eficacia y seguridad de obefazimod, un tratamiento oral que se toma una vez al día, en adultos con enfermedad de Crohn moderadamente a severamente activa. El estudio está diseñado como un ensayo multicéntrico, doble ciego, aleatorizado y controlado con placebo.
El ensayo consta de tres fases: una fase de inducción de 12 semanas, una fase de mantenimiento de 40 semanas y una fase de extensión de 48 semanas. Evaluará el rendimiento de obefazimod en comparación con el placebo en pacientes que han mostrado una respuesta inadecuada a terapias convencionales y/o avanzadas. El objetivo principal de la fase de extensión es evaluar la seguridad y tolerabilidad a largo plazo de obefazimod.
Abivax는 크론병에 대한 obefazimod의 2b상 ENHANCE-CD 임상시험에 첫 번째 환자가 등록되었음을 발표했습니다. 이번 시험의 목표는 중증도에서 심각한 활동성 크론병을 앓고 있는 성인을 대상으로 하루에 한 번 복용하는 경구용 치료제인 obefazimod의 효능과 안전성을 평가하는 것입니다. 이 연구는 다기관, 이중 눈가림, 무작위, 위약 대조 시험으로 설계되었습니다.
이번 시험은 세 가지 단계로 구성됩니다: 12주 유도 단계, 40주 유지 단계, 그리고 48주 연장 단계입니다. obefazimod가 기존 및/또는 고급 치료에 부적절한 반응을 보인 환자에서 위약과 비교할 성과를 평가할 것입니다. 연장 단계의 주요 목표는 obefazimod의 장기적인 안전성과 내약성을 평가하는 것입니다.
Abivax a annoncé l'inscription du premier patient dans son essai de phase 2b ENHANCE-CD pour obefazimod dans la maladie de Crohn. L'essai vise à évaluer l'efficacité et la sécurité d'obefazimod, un traitement oral à prendre une fois par jour, chez les adultes atteints de maladie de Crohn modérément à sévèrement active. L'étude est conçue comme un essai multicentrique, en double aveugle, randomisé et contrôlé par placebo.
L'essai se compose de trois phases : une phase d'induction de 12 semaines, une phase de maintenance de 40 semaines et une phase d'extension de 48 semaines. Il évaluera les performances d'obefazimod par rapport à un placebo chez des patients ayant montré une réponse inadéquate aux thérapies conventionnelles et/ou avancées. L'objectif principal de la phase d'extension est d'évaluer la sécurité et la tolérabilité à long terme d'obefazimod.
Abivax hat die Einschreibung des ersten Patienten in seine Phase 2b ENHANCE-CD Studie für obefazimod bei Morbus Crohn bekannt gegeben. Ziel der Studie ist es, die Wirksamkeit und Sicherheit von obefazimod, einer oral einzunehmenden Behandlung, die einmal täglich verabreicht wird, bei Erwachsenen mit moderat bis stark aktiven Morbus Crohn zu bewerten. Die Studie ist als multizentrische, doppelblinde, randomisierte, placebokontrollierte Studie konzipiert.
Die Studie umfasst drei Phasen: eine 12-wöchige Induktionsphase, eine 40-wöchige Erhaltungsphase und eine 48-wöchige Verlängerungsphase. Es wird die Wirksamkeit von obefazimod im Vergleich zu Placebo bei Patienten bewertet, die auf konventionelle und/oder fortgeschrittene Therapien unzureichend reagiert haben. Das Hauptziel der Verlängerungsphase ist es, die langfristige Sicherheit und Verträglichkeit von obefazimod zu bewerten.
- Initiation of Phase 2b trial for obefazimod in Crohn's disease
- Potential for a convenient, oral, once-daily treatment option
- Addressing unmet needs in Crohn's disease treatment
- None.
Insights
The initiation of the Phase 2b ENHANCE-CD trial for obefazimod in Crohn's disease is a significant milestone for Abivax. This study aims to address a critical unmet need in the treatment of moderate to severe Crohn's disease, particularly for patients who have not responded adequately to existing therapies.
Key points to consider:
- The trial design, including induction, maintenance and extension phases, is comprehensive and aligns with regulatory standards for demonstrating both short-term and long-term efficacy and safety.
- Obefazimod's once-daily oral administration could offer a convenient alternative to injectable biologics, potentially improving patient compliance and quality of life.
- The focus on patients with inadequate response to conventional and advanced therapies targets a challenging subset of the Crohn's disease population, potentially opening a new market segment if successful.
While promising, it's important to note that Phase 2b results are still several years away and success is not guaranteed. Investors should monitor enrollment progress and any interim data releases for early indicators of efficacy and safety.
Abivax Announces First Patient Enrolled in ENHANCE-CD, the Phase 2b Trial of Obefazimod in Crohn’s Disease
PARIS, France, October 3, 2024 – 10:00 p.m. 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 the first patient was enrolled in its Phase 2b ENHANCE-CD (NCT06456593) trial evaluating obefazimod in patients with Crohn’s disease (CD).
The multicenter, double-blind, randomized, placebo-controlled trial will evaluate the efficacy and safety of obefazimod, administered once daily, in adults with moderately to severely active Crohn’s disease.
Fabio Cataldi, MD, Abivax Chief Medical Officer, said, “The enrollment of the first patient in our Phase 2b trial marks a significant step forward in meeting the need for a convenient, oral, once-daily treatment option for people with moderately to severely active Crohn's disease. This milestone brings us closer to addressing the unmet needs of patients seeking effective therapies with fewer burdens on their daily lives."
Trial Design
This trial has 3 treatment phases: a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies. The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared to placebo in subjects who are enrolled in the Extension Phase.
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About Obefazimod
Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with UC have generated positive data, resulting in the initiation of a pivotal global phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. A Phase 2b clinical trial in Crohn’s disease is ongoing, with the first patient enrolled in October 2024, and exploration of potential combination therapy opportunities in UC is ongoing.
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. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @Abivax.
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 “continue,” “could,” “expect,” “goal,” “intend,” “objective,” ”will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax's drug candidates, including obefazimod’s potential to provide meaningful benefit to patients suffering from CD, and other statements that are not historical fact. 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 our 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. 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 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 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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