Abivax Provides Update on Ulcerative Colitis (UC) Combination Therapy Program Strategy and Announces Early Preclinical Combination Data of Obefazimod and Etrasimod in Inflammatory Bowel Disease (IBD) Mouse Model
Abivax has announced initial preclinical combination data of obefazimod and etrasimod in an inflammatory bowel disease (IBD) mouse model. The company is conducting studies with multiple oral and injectable therapies, with additional data expected in Q4 2024. The preclinical evaluation showed improved body weight protection and Disease Activity Index, with a synergistic and statistically significant reduction of several cytokines compared to individual treatments.
Abivax aims to develop a fixed-dose combination therapy for ulcerative colitis (UC) patients, targeting best-in-disease state induction and maintenance efficacy. The company believes obefazimod's safety and efficacy profile makes it an attractive candidate for combination with other mechanisms of action. Abivax plans to select a candidate in 2025 and develop a fixed-dose combination for clinical development.
Abivax ha annunciato i dati iniziali della combinazione preclinica di obefazimod e etrasimod in un modello murino di malattia infiammatoria intestinale (IBD). L'azienda sta conducendo studi con diverse terapie orali e iniettabili, con ulteriori dati attesi per il quarto trimestre del 2024. La valutazione preclinica ha mostrato una migliorata protezione del peso corporeo e un indice di attività della malattia, con una riduzione sinergica e statisticamente significativa di diversi citochine rispetto ai trattamenti singoli.
Abivax mira a sviluppare una terapia combinata a dose fissa per pazienti con colite ulcerosa (UC), puntando a un'efficacia ottimale sia nella fase di induzione che nel mantenimento della malattia. L'azienda crede che il profilo di sicurezza ed efficacia di obefazimod lo renda un candidato interessante per la combinazione con altri meccanismi d'azione. Abivax prevede di selezionare un candidato nel 2025 e sviluppare una combinazione a dose fissa per lo sviluppo clinico.
Abivax ha anunciado los datos iniciales de combinación preclínica de obefazimod y etrasimod en un modelo de ratón de enfermedad inflamatoria intestinal (IBD). La empresa está llevando a cabo estudios con múltiples terapias orales e inyectables, con datos adicionales esperados para el cuarto trimestre de 2024. La evaluación preclínica mostró una mejor protección del peso corporal y un índice de actividad de la enfermedad, con una reducción sinérgica y estadísticamente significativa de varios citoquinas en comparación con los tratamientos individuales.
Abivax tiene como objetivo desarrollar una terapia combinada a dosis fija para pacientes con colitis ulcerosa (UC), buscando la mejor eficacia en la inducción y el mantenimiento de la enfermedad. La empresa cree que el perfil de seguridad y eficacia de obefazimod lo convierte en un candidato atractivo para combinarlo con otros mecanismos de acción. Abivax planea seleccionar un candidato en 2025 y desarrollar una combinación a dosis fija para el desarrollo clínico.
Abivax는 obefazimod와 etrasimod의 초기 전임상 조합 데이터를 염증성 장질환 (IBD) 마우스 모델에서 발표했습니다. 이 회사는 여러 경구 및 주사 요법에 대한 연구를 진행하고 있으며, 2024년 4분기에 추가 데이터가 기대됩니다. 전임상 평가 결과, 체중 보호와 질병 활동 지수가 개선되었으며, 개별 치료와 비교해 여러 사이토카인의 통계적으로 유의미한 시너지적 감소가 나타났습니다.
Abivax는 궤양성 대장염 (UC) 환자를 위한 고정 용량 комбини치료법을 개발하는 것을 목표로 하며, 질병의 유도 및 유지 효능에서 최상의 결과를 목표로 하고 있습니다. 회사는 obefazimod의 안전성 및 유효성 프로필이 다른 작용 메커니즘과의 조합 후보로 매력적이라고 믿고 있습니다. Abivax는 2025년에 후보를 선정하고 임상 개발을 위한 고정 용량 조합을 개발할 계획입니다.
Abivax a annoncé les premières données de combinaison préclinique d'obefazimod et d'etrasimod dans un modèle animal de maladie inflammatoire intestinale (IBD). L'entreprise mène des études avec plusieurs thérapies orales et injectables, avec des données supplémentaires attendues au quatrième trimestre 2024. L'évaluation préclinique a montré une meilleure protection du poids corporel et un indice d'activité de la maladie, avec une réduction synergique et statistiquement significative de plusieurs cytokines par rapport aux traitements individuels.
Abivax vise à développer une thérapie combinée à dose fixe pour les patients atteints de colite ulcéreuse (UC), visant à obtenir la meilleure efficacité d'induction et de maintenance de la maladie. L'entreprise estime que le profil de sécurité et d'efficacité d'obefazimod en fait un candidat attrayant pour une combinaison avec d'autres mécanismes d'action. Abivax prévoit de sélectionner un candidat en 2025 et de développer une combinaison à dose fixe pour le développement clinique.
Abivax hat die ersten präklinischen Kombinationsdaten von obefazimod und etrasimod in einem Mausmodell für entzündliche Darmerkrankungen (IBD) bekannt gegeben. Das Unternehmen führt Studien mit mehreren oralen und injizierbaren Therapien durch, von denen zusätzliche Daten für das vierte Quartal 2024 erwartet werden. Die präklinische Evaluierung zeigte einen verbesserten Schutz des Körpergewichts und einen Disease Activity Index, mit einer synergistischen und statistisch signifikanten Reduktion mehrerer Zytokine im Vergleich zu einzelnen Behandlungen.
Abivax strebt die Entwicklung einer fixen Kombinationstherapie für Patienten mit Colitis ulcerosa (UC) an, die darauf abzielt, die beste Wirksamkeit bei der Induktion und Erhaltung der Erkrankung zu erreichen. Das Unternehmen ist überzeugt, dass das Sicherheits- und Wirksamkeitsprofil von obefazimod es zu einem attraktiven Kandidaten für die Kombination mit anderen Wirkmechanismen macht. Abivax plant, 2025 einen Kandidaten auszuwählen und eine fixe Kombinationsdosis für die klinische Entwicklung zu entwickeln.
- Preclinical data shows synergistic effects of obefazimod and etrasimod combination in IBD mouse model
- Combination therapy improved body weight protection and Disease Activity Index
- Statistically significant reduction of several cytokines observed in combination therapy
- Abivax aims to develop a fixed-dose combination therapy for UC patients
- Company plans to select a candidate for fixed-dose combination in 2025
- None.
Insights
The preclinical combination study of obefazimod and etrasimod in an IBD mouse model shows promising results, potentially addressing the efficacy ceiling in IBD treatments. Key findings include:
- Improved body weight protection and Disease Activity Index
- Synergistic and statistically significant reduction in inflammatory cytokines (TNF-alpha, IL-17, IL-6, IFN-gamma)
- Potential for a fixed-dose combination therapy with best-in-disease induction and maintenance efficacy
This early data suggests a possible breakthrough in IBD treatment, particularly for ulcerative colitis. However, it's important to note that these are preclinical results and human trials will be necessary to confirm efficacy and safety. Abivax's strategy to explore multiple combination therapies and select a candidate by 2025 indicates a long-term approach to drug development.
The company's focus on developing a combination therapy with an IP runway into the late 2040s could provide a significant competitive advantage if successful. Investors should monitor upcoming scientific conference presentations and year-end updates for further insights into the program's progress.
From a financial perspective, this update on Abivax's combination therapy program has several implications:
- Potential for expanded market opportunity if the combination therapy proves more effective than current treatments
- Long-term IP protection into the late 2040s could secure revenue streams well into the future
- Ongoing R&D expenses for preclinical and future clinical studies may impact short-term financials
- Partnerships or licensing opportunities could arise from this innovative approach
With a market cap of
While this news is positive for long-term prospects, it's unlikely to have an immediate impact on stock performance. Investors should closely monitor future clinical trial results and regulatory milestones as key value inflection points.
Abivax Provides Update on Ulcerative Colitis (UC) Combination Therapy Program Strategy and Announces Early Preclinical Combination Data of Obefazimod and Etrasimod in Inflammatory Bowel Disease (IBD) Mouse Model
- Abivax is actively conducting preclinical studies with multiple oral and injectable therapies and will report additional data in Q4 2024.
- Pre-clinical evaluation of obefazimod combined with etrasimod improved body weight protection and Disease Activity Index with a synergistic and statistically significant reduction of several cytokines (TNF-alpha, IL-17, IL-6, IFN-gamma) in the blood compared to each treatment alone.
PARIS, France, September 25, 2024, 10:00 p.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 results of initial preclinical combination data of obefazimod combined with etrasimod in a mouse model of IBD.
“Despite progress and development of multiple new advanced targeted therapies in IBD, efficacy rates appear to have reached a ceiling. Fewer than half of patients achieve clinical remission, and many of those lose response over time. It is imperative for our field to explore rational and scientifically driven combination therapies to break through the efficacy ceiling, which in turn will lead to improved long-term outcomes for patients,” said David Rubin, MD Professor of Medicine and Chief, Gastroenterology, Hepatology and Nutrition at The University of Chicago.
“Our goal for this program is to develop a fixed-dose combination therapy for UC patients that delivers best-in-disease state induction and maintenance efficacy, a safety profile on par with obefazimod, and an IP runway into the late 2040’s”, said Marc de Garidel, CEO of Abivax. He went on to say, “We believe that obefazimod's emerging safety and efficacy profile, with potentially best-in-disease maintenance efficacy, could provide a meaningful benefit to patients when taken as a monotherapy. Additionally, since obefazimod is an oral therapy that has thus far demonstrated a favorable safety profile, it is an attractive candidate to be combined with other mechanisms of action to attempt to break through the efficacy ceiling observed with advanced therapies."
Fabio Cataldi, MD Chief Medical Officer of Abivax provided key elements of the combination therapy program. “This program involves multiple stages. First, we will perform additional pre-clinical experiments evaluating the efficacy of obefazimod in combination with several other mechanisms of action. Based on our findings, we plan to select a candidate in 2025 and work towards developing a fixed dose combination to move into clinical development.”
“We are setting a high bar for success and are excited about the promising data we are generating with this preclinical combination program,” Mr. de Garidel said. “We are planning to present this data at an upcoming scientific conference and are actively conducting additional combination studies that address various disease pathways. We look forward to providing an update on our progress by year end.”
Pre-Clinical Program and Initial Findings
Preclinical evaluation of obefazimod combined with etrasimod, was conducted in the T-cell adoptive transfer mouse model. In this study, CD4+CD45high or CD4+CD45low cells were intraperitoneally injected to 6-week-old male C57BL/6NRj-Rag2tm1Ciphe/Rj mice (10 mice per group). The mice were then orally treated for 55 days with obefazimod or etrasimod alone or with the combination of both compounds. The results showed that treatment with the combination improved the response on body weight protection and Disease Activity Index with a synergistic and statistically significant reduction of several cytokines (TNF-alpha, IL-17, IL-6, IFN-gamma) in the blood compared to each drug alone.
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 on X, formerly Twitter, @Abivax.
Contact:
Patrick Malloy
SVP, Investor Relations, Abivax
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 “expect,” “plan,” “potential,” “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, the availability and timing of preclinical data to support decision-making on therapy candidates for use in combination with obefazimod in UC, as well as the availability and timing of disclosure of preclinical data of any such combination therapy, the timing of initiation of clinical trials, obefazimod’s potential, as monotherapy or in combination with other therapies, to provide meaningful benefit to patients suffering from UC, Crohn’s disease, IBD or other indications, 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
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