Afimkibart – TUSCANY Phase IIa Trial
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Phase IIa, open-label study evaluating afimkibart, an anti-TL1A monoclonal antibody, in moderate-to-severe ulcerative colitis patients.
Location
UK, EU, US
Category
Hudson Yards, New York
Year
2023
The TUSCANY trial investigated afimkibart’s potential to modulate inflammatory pathways involved in ulcerative colitis (UC), a chronic autoimmune condition characterized by colonic inflammation. Conducted across multiple international sites, the study enrolled patients with moderate to severe disease who had experienced inadequate response or intolerance to conventional therapies. Afimkibart targets TL1A, a cytokine implicated in driving intestinal inflammation, thereby addressing disease pathogenesis at a novel checkpoint.
Patients received seven intravenous doses of 500 mg afimkibart biweekly, with assessments including endoscopic, histologic, and clinical outcomes at weeks 6 and 14. The trial reported an encouraging 38.2% of participants achieved endoscopic improvement by week 14, demonstrating meaningful mucosal healing. Safety and tolerability were favorable, with adverse events comparable to placebo-treated populations in similar studies. Importantly, no serious adverse events were attributed to the drug, supporting its potential as a new treatment option.
Beyond efficacy, the trial incorporated biomarker analyses examining TL1A expression and immune cell profiles in biopsy samples. These translational studies provided insights into the drug’s mechanism of action and patient subgroups most likely to benefit. Afimkibart’s impact extended to Crohn’s disease, with parallel studies underway, highlighting the broader relevance of TL1A inhibition across inflammatory bowel diseases.
The promising results led to the initiation of Phase III studies (TUSCANY-2 and beyond), aiming to confirm durability of response and long-term safety. If successful, afimkibart could offer a targeted biologic with a differentiated mechanism, expanding therapeutic options for patients with refractory UC.
