Abivax to Present Three Abstracts for Obefazimod in Ulcerative Colitis at the UEG Week 2024
Abivax announced that three scientific abstracts on its lead drug candidate, obefazimod, will be presented at the United European Gastroenterology (UEG) Week meeting in Vienna, Austria, from October 12-15, 2024. The presentations will focus on obefazimod's efficacy and safety in treating ulcerative colitis (UC).
The presentations include:
- An oral presentation by Prof. Bruce E. Sands on the efficacy and safety of obefazimod at week 48 in UC patients who were non-responders at week 8 of the Phase 2b induction trial.
- Two moderated poster presentations: one by Prof. Séverine Vermeire on corticosteroid-free efficacy and safety at weeks 48 and 96, and another by Prof. Britta Siegmund on the impact of obefazimod on histologic and endoscopic outcomes at week 8.
Abivax's Chief Medical Officer, Fabio Cataldi, MD, expressed optimism about obefazimod's potential to advance the treatment paradigm for UC as a once-daily oral therapy.
Abivax ha annunciato che tre abstract scientifici sul suo principale candidato farmacologico, obefazimod, saranno presentati al meeting della United European Gastroenterology (UEG) Week che si terrà a Vienna, Austria, dal 12 al 15 ottobre 2024. Le presentazioni si concentreranno sull'efficacia e sulla sicurezza di obefazimod nel trattamento della colite ulcerosa (UC).
Le presentazioni includono:
- Una presentazione orale del Prof. Bruce E. Sands sull'efficacia e sulla sicurezza di obefazimod alla settimana 48 in pazienti con UC che non hanno risposto alla settimana 8 della fase 2b dello studio di induzione.
- Due presentazioni poster moderate: una del Prof. Séverine Vermeire sull'efficacia e la sicurezza senza corticosteroidi alle settimane 48 e 96, e l'altra del Prof. Britta Siegmund sull'impatto di obefazimod su risultati istologici ed endoscopici alla settimana 8.
Il Chief Medical Officer di Abivax, Fabio Cataldi, MD, ha espresso ottimismo riguardo al potenziale di obefazimod di far progredire il paradigma del trattamento per l'UC come terapia orale da assumere una volta al giorno.
Abivax anunció que se presentarán tres resúmenes científicos sobre su principal candidato a fármaco, obefazimod, en la reunión de la United European Gastroenterology (UEG) Week que se llevará a cabo en Viena, Austria, del 12 al 15 de octubre de 2024. Las presentaciones se centrarán en la eficacia y seguridad de obefazimod en el tratamiento de la colitis ulcerosa (UC).
Las presentaciones incluirán:
- Una presentación oral del Prof. Bruce E. Sands sobre la eficacia y seguridad de obefazimod a la semana 48 en pacientes con UC que no respondieron a la semana 8 del ensayo de inducción de fase 2b.
- Dos presentaciones de póster moderadas: una del Prof. Séverine Vermeire sobre la eficacia y seguridad sin corticosteroides a las semanas 48 y 96, y otra del Prof. Britta Siegmund sobre el impacto de obefazimod en los resultados histológicos y endoscópicos a la semana 8.
El Director Médico de Abivax, Fabio Cataldi, MD, expresó optimismo sobre el potencial de obefazimod para avanzar en el paradigma de tratamiento de la UC como terapia oral de una vez al día.
Abivax는 2024년 10월 12일부터 15일까지 오스트리아 비엔나에서 열리는 유럽소화기학회(UEG) 주에서 자사 주요 약물후보인 obefazimod에 대한 3개의 과학 초록을 발표할 예정이라고 알렸습니다. 발표는 obefazimod의 궤양성 대장염(UC) 치료에 대한 효능과 안전성에 중점을 둘 것입니다.
발표 내용은 다음과 같습니다:
- Phase 2b 유도 시험의 8주 차에 반응이 없었던 UC 환자에서 48주째 obefazimod의 효능과 안전성에 대해 브루스 E. 샌즈 교수의 구두 발표.
- 두 개의 발표 포스터: 세베리느 베르메르 교수의 코르티코스테로이드 비사용의 효능과 안전성에 대한 발표와 브리타 지그문트 교수의 8주차에서 obefazimod의 조직학적 및 내시경 결과에 대한 영향을 다룬 발표.
Abivax의 최고 의학 책임자 파비오 카탈디 박사는 obefazimod가 UC 치료 패러다임을 하루 한 번 복용하는 경구 치료제로 발전시킬 수 있는 잠재력에 대해 낙관론을 보였습니다.
Abivax a annoncé que trois résumés scientifiques concernant son principal candidat médicament, obefazimod, seront présentés lors de la réunion de la United European Gastroenterology (UEG) Week à Vienne, en Autriche, du 12 au 15 octobre 2024. Les présentations seront axées sur l'efficacité et la sécurité d'obefazimod dans le traitement de la colite ulcéreuse (CU).
Les présentations comprennent :
- Une présentation orale du Prof. Bruce E. Sands sur l'efficacité et la sécurité d'obefazimod à la semaine 48 chez des patients atteints de CU qui n'avaient pas répondu à la semaine 8 de l'étude d'induction de phase 2b.
- Deux présentations de posters modérées : l'une par le Prof. Séverine Vermeire sur l'efficacité et la sécurité sans corticostéroïdes aux semaines 48 et 96, et l'autre par le Prof. Britta Siegmund sur l'impact d'obefazimod sur les résultats histologiques et endoscopiques à la semaine 8.
Le directeur médical d'Abivax, Fabio Cataldi, MD, a exprimé son optimisme quant au potentiel d'obefazimod pour faire progresser le paradigme de traitement de la CU en tant que thérapie orale à prendre une fois par jour.
Abivax gab bekannt, dass drei wissenschaftliche Abstracts zu seinem Hauptkandidaten, obefazimod, auf dem United European Gastroenterology (UEG) Week Meeting in Wien, Österreich, vom 12. bis 15. Oktober 2024 präsentiert werden. Die Präsentationen werden sich auf die Wirksamkeit und Sicherheit von obefazimod bei der Behandlung von Colitis ulcerosa (UC) konzentrieren.
Die Präsentationen umfassen:
- Einen mündlichen Vortrag von Prof. Bruce E. Sands über die Wirksamkeit und Sicherheit von obefazimod in der Woche 48 bei UC-Patienten, die in der Woche 8 der Phase 2b-Induktionsstudie nicht angesprochen haben.
- Zwei moderierte Posterpräsentationen: eine von Prof. Séverine Vermeire zur Wirksamkeit und Sicherheit ohne Kortikosteroide in den Wochen 48 und 96 und eine weitere von Prof. Britta Siegmund über die Auswirkungen von obefazimod auf histologische und endoskopische Ergebnisse in Woche 8.
Der Chief Medical Officer von Abivax, Fabio Cataldi, MD, äußerte Optimismus bezüglich des Potenzials von obefazimod, das Behandlungskonzept für UC als einmal täglich einzunehmende orale Therapie voranzubringen.
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Abivax to Present Three Abstracts for Obefazimod in Ulcerative Colitis at the UEG Week 2024
- Professor Bruce E. Sands, MD to present oral presentation of Phase 2b, open-label, maintenance efficacy and safety data at weeks 48 and 96 among week 8 induction non-responders in obefazimod-treated patients with moderately to severely active ulcerative colitis (UC)
- Two moderated poster presentations highlighting corticosteroid-free efficacy and safety data of obefazimod at weeks 48 and 96 of an open-label maintenance trial, as well as the impact of obefazimod induction therapy on combined histologic and endoscopic outcomes at week 8 in patients with UC
PARIS, France, September 26, 2024 – 08:30 a.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 that three scientific abstracts on its lead drug candidate, obefazimod, will be presented during the United European Gastroenterology (UEG) Week meeting, Oct. 12-15, 2024, in Vienna, Austria.
“We look forward to returning to UEGW to share new analysis of our Phase 2b trial data on obefazimod in patients with moderately to severely active ulcerative colitis,” said Abivax Chief Medical Officer Fabio Cataldi, MD. “With this presentation, we have observed additional evidence that obefazimod has the potential to advance the treatment paradigm, designed to be a once-daily oral therapy, for people living with ulcerative colitis.”
For more information on the Abivax clinical program and company updates, please see the conference program at the UEG website.
Obefazimod data to be presented:
| Presentation Title | Session | Presenter | Abstract/Poster Number | Date/Time of Presentation |
| Oral Presentation | ||||
| Efficacy and safety of obefazimod in UC patients at week 48 of an open-label maintenance study among clinical non-responders at week 8 of the Phase 2b induction trial | IBD New horizons in medical treatment - Part 2 | Prof. Bruce E. Sands, M.D., M.S. Dr. Burrill B. Crohn Professor of Medicine and Chief, Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, NY | Tuesday, Oct. 15, 2024, from 11:30 AM to 12:30 PM CEST | |
| Moderated Poster Presentations | ||||
| Corticosteroid-free efficacy and safety of UC patients receiving once-daily obefazimod in an open label 96-week maintenance study among patients who were receiving concomitant corticosteroids at induction baseline | Small molecules in the treatment of IBD | Prof. Séverine Vermeire, MD, PhD. Head of the IBD Center at the University Hospitals Leuven, Belgium, and principal investigator in Europe for the study programs conducted and ongoing with obefazimod in UC | Tuesday, Oct. 15, 2024, from 14:30 PM to 15:30 PM CEST | |
| Impact of obefazimod induction therapy on histologic and combined histologic and endoscopic outcomes in patients with moderately to severely active ulcerative colitis: week 8 results from the Phase 2b induction trial | Small molecules in the treatment of IBD | Prof. Britta Siegmund, MD, PhD Medical Director, Division of Gastroenterology, Infectiology and Rheumatology, Universitätsmedizin Berlin | Tuesday, Oct. 15, 2024, from 14:30 PM to 15:30 PM CEST | |
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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. 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, 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 “expect,” “forward”,” 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, as well as the timing of initiation of a Phase 2b clinical trial of obefazimod in Crohn’s disease. 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) which 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.
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