Phase 2b Study Data Available on Obefazimod for Ulcerative Colitis (UC)


In a news release from mid-April 2023, clinical-stage biotechnology company Abivax SA shared that 2-year results were available from a Phase 2b open-label maintenance study evaluating obefazimod for individuals living with moderate-to-severe ulcerative colitis (UC). 222 individuals enrolled in the initial study, with 217 continuing onto the maintenance portion. Participants received 50mg obefazimod each day – administered orally – for a 96-week period. The goal was to determine the drug’s safety, efficacy, and tolerability. More importantly, many people with ulcerative colitis struggle to find effective long-term treatment, so this trial sought to understand whether obefazimod could confer lasting and meaningful benefits.

Obefazimod: A Potential Ulcerative Colitis Therapy?

Abivax describes obefazimod as:
an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory activity. Because of its ability to greatly upregulate the production of a unique RNA splicing product and anti-inflammatory agent, miR-124, the mechanism of action of obefazimod is unique and has shown promise in clinical trials in its ability to bring patients into remission and heal inflammatory lesions in UC.
In the maintenance portion, patients received therapy for up to 2 years. 153 participants (70.5%) had some form of clinical response to treatment. 114 participants (52.5%) entered into clinical remission by the end of the trial. Additionally, there were endoscopic benefits, with improvement seen in 59% of participants and remission in 35.9%. Obefazimod was found to be safe and well-tolerated. In fact, the researchers believe that available safety data would support the use of obefazimod as a daily treatment.

Understanding this Disease

Ulcerative colitis exists under the greater umbrella of inflammatory bowel disease (IBD); Crohn’s disease also exists under this category. UC is a chronic inflammatory disease which causes the formation of ulcers and sores in the large intestine. This disease most often manifests in young adults (ages 15-35), though it has also shown prevalence in people older than 60. People with a family history of IBD, or people of Ashkenazi Jewish descent, are also at a higher risk of having ulcerative colitis. Inflammation caused by this condition typically affects the innermost intestinal lining. Symptoms vary in severity. These may include:

  • Loose bowel movements
  • Fatigue
  • Bloody stool
  • Unintentional weight loss
  • Appetite loss
  • Rectal pain and bleeding
  • Abdominal pain, cramping, and distention
  • Anemia (low red blood cell count)
  • Nausea
  • Joint pain
  • Rash

Controlling inflammation can help you to manage your symptoms, so treatments are designed to aid in inflammation reduction. Treatment options may include antibiotics, aminosalicylates, biologics, corticosteroids, immunomodulators, and targeted oral small molecules. If these treatments are ineffective, surgery may be required.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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