– TLR9 Agonist for the Treatment of Chronic, Active, Treatment-Refractory Ulcerative Colitis –
InDex Pharmaceuticals today announced the start of the COLLECT trial, a European multicenter Phase III study to evaluate the effectiveness and safety of Kappaproct for the treatment of chronic active ulcerative colitis (UC) patients not responding to available therapy. Kappaproct is a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9).
UC is a chronic, relapsing-remitting disease caused by inflammation of the colon. Although current UC treatments are effective for many patients with mild to moderate disease, a significant unmet medical need still exists for patients with severe UC. Many of these patients have failed all available pharmaceutical therapies – therefore, surgical removal of the colon by partial or complete colectomy is currently the only remaining treatment option.
The primary endpoint of the COLLECT study is induction of clinical remission in these severe UC patients, who have failed all other medical treatments and have been elected for colectomy. Preliminary results are expected for Q1, 2014.