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Abivax: Results from Obefazimod Trials in Ulcerative Colitis

Abivax has released the results of its phase 3 trials on Obefazimod, showing notable improvements in patients with ulcerative colitis.


Abivax: Results from Obefazimod Trials in Ulcerative Colitis

Significant Improvement in Patient-Reported Outcomes

Abivax announced that the phase 3 trials, named ABTECT, for the treatment of ulcerative colitis with Obefazimod have shown significant improvement in patient-reported parameters. According to the data collected up to the eighth week, 37% of patients who received a daily dose of 50 mg of Obefazimod reported an absence of bowel urgency, compared to 18.1% in the placebo group. Additionally, 47.6% of patients in the same group reported no nocturnal stools, versus 24.7% among those taking a placebo. Lastly, a remission of fatigue was noted in 17.1% of patients on Obefazimod, while only 7.7% in the placebo group reported such results.

Importance of Patient-Reported Outcomes (PROs)

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Abivax emphasizes the importance of patient-reported outcomes (PROs) to assess the impact of treatments. These PROs include bowel urgency, frequency of nocturnal stools, and fatigue, among others. The results suggest that Obefazimod could improve the overall quality of life for patients, a crucial aspect for those suffering from ulcerative colitis, a disease that can deeply impact daily life, according to Marla Dubinsky, professor at the Icahn School of Medicine in New York. These data will be presented at upcoming medical conferences for further discussion.

Future Plans and Ongoing Trials

Abivax plans to publish more detailed results in the coming months and hopes to present an analysis of the data at medical conferences. Additionally, the company is working on a maintenance trial expected to conclude in the second quarter of 2026. Abivax, specializing in the development of treatments for chronic inflammatory diseases, sees these positive results as an important step towards a potential new therapeutic option for patients suffering from ulcerative colitis. CEO Marc de Garidel highlighted Abivax's commitment to providing more effective and better-tolerated treatments, thus addressing a significant medical need.



Sector Santé · Biotechnologies · Pharmacie Biotechnologie


Assurance vie

Context

Period
  • Period: 3T 2025
Guidance from the release
  • Trésorerie et équivalents de trésorerie de 589,7 millions d'euros au 30/09/2025 ; perte nette de 254,1 millions d'euros sur les neuf mois ; produit net d'ADS d'environ 700,3 millions de dollars (?597,2 M€) en juillet 2025 ; position financière nette de 543,3 millions d'euros ; autonomie financière attendue jusqu'au T4 2027. Hausse significative des dépenses R&D et des charges G&A.
Risks mentioned
  • Risques inhérents à la recherche et au développement clinique
  • Risque lié aux décisions des autorités réglementaires (FDA, EMA)
  • Risque de disponibilité insuffisante de fonds pour couvrir les dépenses d'exploitation futures
  • Obstacles potentiels au développement clinique et pharmaceutique (données précliniques, CMC, toxicologie, etc.)
Opportunities identified
  • Avancement des essais de phase 3 d'Obefazimod en rectocolite hémorragique
  • Présentations 'late-breaking' et résultats favorables communiqués lors de congrès scientifiques
  • Produit net élevé de l'offre d'ADS prolongeant l'autonomie financière jusqu'au T4 2027

The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.

Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.

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