information: Clinical trial authorisation
Announcement: clinical trial authorization
Company: Abivax (France)
- splice modulating agent. ABX464 is a first-in-class, small molecule inhibiting HIV replication through the inhibition of the Rev protein activity and modulation of RNA splicing. Preclinical data published in Nature Scientific Reports show ABX464 dampened intestinal inflammation by triggering IL-22 production.
Disease: ulcerative colitis
area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country: Belgium, Czech Republic, France, Germany, Hungary, Poland, Spain
- ABX464-101 is a Phase 2a study aimed at evaluating the safety and efficacy of ABX464 in 30 patients with ulcerative colitis who have failed or are intolerant to immunomodulators, anti-TNFalpha, vedolizumab and/or corticosteroids. Patients will be randomized to receive either ABX464 50mg or placebo given once daily for eight weeks. Exploratory objectives include assessing the clinical remission and mucosal healing of the ulcerative colitis lesions.
- This clinical study is being conducted in 18 centers in eight
- ABX464-102 is a twelve-month open label follow-up study for patients with ulcerative colitis benefiting from the administration of ABX464 in the ABX464-101 study.
- • On January 4, 2018, Abivax announced that the follow-up protocol ABX464-102 has been authorized by the Regulatory Authority and Ethics Committee in Belgium. The new study will recruit patients from the ongoing ulcerative colitis proof-of-concept study (ABX464-101) who are responding to treatment with ABX464 into the 12-month open label follow-up study (ABX464-102). The authorization was based on the safety of ABX464 observed in long-term preclinical
- • On September 20, 2017, Abivax announced that the French National Regulatory Authority (ANSM) has approved the ABX464-101 Phase 2a “Proof-of-Concept” study of ABX464 in patients with moderate to severe active ulcerative colitis. The company is now looking forward to initiating this study in the fourth quarter of 2017. The study will be conducted in seven European countries. Regulatory and ethics committee approvals are being sought in all these countries.