Abivax Announces ABTECT Phase 3 Trial Achieves Key Enrollment Milestone
Abivax (ABVX) has reached a significant milestone in its Phase 3 ABTECT trial for obefazimod, a treatment for moderately to severely active ulcerative colitis (UC). The trial has surpassed 600 enrolled patients, keeping it on track to achieve full enrollment by early Q1 2025. This progress aligns with the company's expectations and reflects similar baseline characteristics and trends observed in the earlier Phase 2b trial.
The ABTECT trial is a important step in Abivax's development of therapeutics that aim to stabilize the immune response in chronic inflammatory diseases. The company's approach focuses on harnessing the body's natural regulatory mechanisms. With this enrollment milestone, Abivax reaffirms its timeline for the trial's completion, potentially bringing obefazimod closer to market for UC patients.
Abivax (ABVX) ha raggiunto un traguardo significativo nel suo trial di Fase 3 ABTECT per obefazimod, un trattamento per la colite ulcerosa (UC) di grado moderato-severo. Il trial ha superato i 600 pazienti arruolati, mantenendosi in linea con l'obiettivo di completare l'arruolamento entro all'inizio del primo trimestre del 2025. Questo progresso si allinea con le aspettative dell'azienda e riflette caratteristiche di base e tendenze simili osservate nel precedente trial di Fase 2b.
Il trial ABTECT rappresenta un passo importante nello sviluppo di terapie da parte di Abivax, che mirano a stabilizzare la risposta immunitaria nelle malattie infiammatorie croniche. L'approccio dell'azienda si concentra sull'utilizzo dei meccanismi naturali di regolazione del corpo. Con questo traguardo nell'arruolamento, Abivax riafferma la sua tempistica per il completamento del trial, avvicinando potenzialmente obefazimod al mercato per i pazienti affetti da colite ulcerosa.
Abivax (ABVX) ha alcanzado un hito significativo en su ensayo de Fase 3 ABTECT para obefazimod, un tratamiento para la colitis ulcerosa (UC) de moderada a severa. El ensayo ha superado los 600 pacientes inscritos, manteniéndose en camino para lograr el total de inscripción para principios del primer trimestre de 2025. Este progreso está en línea con las expectativas de la empresa y refleja características y tendencias similares observadas en el ensayo anterior de Fase 2b.
El ensayo ABTECT es un paso importante en el desarrollo de terapias de Abivax, que buscan estabilizar la respuesta inmune en enfermedades inflamatorias crónicas. El enfoque de la empresa se centra en aprovechar los mecanismos regulatorios naturales del cuerpo. Con este hito en la inscripción, Abivax reafirma su cronograma para la finalización del ensayo, acercando potencialmente a obefazimod al mercado para los pacientes con UC.
Abivax (ABVX)는 중등도에서 중증의 궤양성 대장염(UC) 치료제인 obefazimod에 대한 3상 ABTECT 임상시험에서 중요한 이정표에 도달했습니다. 이 시험은 600명 이상의 환자를 등록했습니다, 2025년 1분기 초까지 전체 등록을 달성할 목표를 보장하고 있습니다. 이 진행 상황은 회사의 기대에 부합하며 이전의 2b상 시험에서 관찰된 유사한 기초 특성과 경향을 반영합니다.
ABTECT 시험은 Abivax의 만성 염증 질환에 대한 면역 반응을 안정화하는 치료제 개발에 중요한 단계입니다. 회사의 접근 방식은 신체의 자연적인 조절 메커니즘을 활용하는 데 중점을 두고 있습니다. 이 등록 이정표와 함께 Abivax는 시험 완료 일정에 대한 자신감을 재확인하며, obefazimod이 UC 환자들을 위한 시장에 더 가까워질 수 있습니다.
Abivax (ABVX) a atteint un jalon significatif dans son essai de Phase 3 ABTECT pour l'obefazimod, un traitement pour la colite ulcéreuse (UC) modérée à sévère. L’essai a dépasse les 600 patients inscrits, restant sur la bonne voie pour atteindre l'inscription complète d'ici début du premier trimestre 2025. Ce progrès est en ligne avec les attentes de l'entreprise et reflète des caractéristiques de base et des tendances similaires observées dans l'essai précédent de phase 2b.
L'essai ABTECT est une étape importante dans le développement par Abivax de traitements visant à stabiliser la réponse immunitaire dans les maladies inflammatoires chroniques. L'approche de l'entreprise se concentre sur l'exploitation des mécanismes de régulation naturels du corps. Avec ce jalon d'inscription, Abivax réaffirme son calendrier pour l'achèvement de l'essai, rapprochant potentiellement l'obefazimod du marché pour les patients atteints de colite ulcéreuse.
Abivax (ABVX) hat einen bedeutenden Meilenstein in seiner Phase-3-Studie ABTECT für obefazimod erreicht, ein Behandlungsmittel für mäßig bis schwer aktive Colitis ulcerosa (UC). Die Studie hat mehr als 600 eingeschriebene Patienten überschritten, was es ermöglicht, den vollständigen Einschreibungsprozess bis früh im ersten Quartal 2025 abzuschließen. Dieser Fortschritt entspricht den Erwartungen des Unternehmens und spiegelt ähnliche Ausgangsmerkmale und Trends wider, die in der vorherigen Phase-2b-Studie beobachtet wurden.
Die ABTECT-Studie ist ein wichtiger Schritt in der Entwicklung von Therapeutika durch Abivax, die die Immunantwort bei chronisch entzündlichen Erkrankungen stabilisieren sollen. Der Ansatz des Unternehmens konzentriert sich darauf, die natürlichen Regulationsmechanismen des Körpers zu nutzen. Mit diesem Einschreibemeilenstein bekräftigt Abivax seinen Zeitplan für den Abschluss der Studie und bringt obefazimod potenziell näher an den Markt für UC-Patienten.
- Phase 3 ABTECT trial for obefazimod in ulcerative colitis surpassed 600 enrolled patients
- Trial enrollment is on pace to reach full capacity in early Q1 2025, as expected
- Baseline participant characteristics and trial trends align with observations from the Phase 2b trial
- None.
Insights
The ABTECT Phase 3 trial for obefazimod in ulcerative colitis (UC) reaching the 600-patient enrollment milestone is a significant development for Abivax. This progress suggests strong interest from both patients and clinicians in this potential treatment. The trial's pace indicates full enrollment by early Q1 2025, which is important for timely completion of the study.
Importantly, the baseline characteristics and trial trends aligning with the Phase 2b observations provide early confidence in the consistency of the patient population. This could potentially increase the likelihood of replicating positive Phase 2b results in the larger Phase 3 cohort. However, it's essential to note that Phase 3 trials can sometimes yield different outcomes due to their larger scale and longer duration.
For investors, this news signals that Abivax is executing its clinical development plan effectively, which could positively impact the company's valuation and future prospects in the competitive UC treatment market.
Abivax's progress with the ABTECT Phase 3 trial is noteworthy in the context of the ulcerative colitis treatment landscape. The company's obefazimod, if successful, could enter a market dominated by biologics and JAK inhibitors. The enrollment milestone suggests strong investigator interest and potentially addresses an unmet need in UC treatment.
The trial's size and pace are competitive within the industry, indicating Abivax's commitment to robust clinical development. However, investors should consider that successful enrollment doesn't guarantee positive trial outcomes or regulatory approval. The alignment with Phase 2b characteristics is promising but not definitive.
From a market perspective, Abivax's progress could attract partnership interest from larger pharmaceutical companies looking to expand their inflammatory bowel disease portfolios. This milestone may also strengthen Abivax's position in future financing rounds or partnerships, potentially impacting the company's valuation and strategic options.
Abivax Announces ABTECT Phase 3 Trial Achieves Key Enrollment Milestone
- Phase 3 ABTECT Trial evaluating obefazimod in moderately to severely active ulcerative colitis (UC) surpassed the 600-patient enrollment milestone confirming ABTECT currently on pace to reach full enrollment in early Q1 2025
- To date, baseline participants baseline characteristics and trial trends in line with observations from Phase 2b trial
PARIS, France, August 6, 2024, 8:30 a.m. CEST – Abivax SA (Euronext Paris & 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, announced today that in July 2024, the 600th participant was enrolled in the Phase 3 ABTECT Trial. Based on this milestone and current enrollment pace, the Company reaffirms expectations to reach full enrollment in early Q1 2025. An updated version of the Company’s corporate presentation reflecting these updates can be found on its website at www.abivax.com.
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. Initiation of a Phase 2b clinical trial in Crohn’s disease is expected in Q3 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 X (former Twitter).
Contact
| Patrick Malloy SVP, Investor Relations Abivax patrick.malloy@abivax.com +1 847 987 4878 |
| or |
| Abivax Communications communications@abivax.com |
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 “expect,” “potential” 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, Abivax’s expectations regarding timing of enrollment for its Phase 3 ABTECT induction trial, 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. Current results are not necessarily indicative of future results. 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
What is the current status of Abivax's Phase 3 ABTECT trial for obefazimod (ABVX)?
What condition is Abivax's obefazimod (ABVX) being tested for in the ABTECT trial?
When does Abivax (ABVX) expect to complete enrollment for the Phase 3 ABTECT trial?
How do the baseline characteristics of participants in Abivax's Phase 3 ABTECT trial compare to previous trials?
