Company News: InDex Pharmaceuticals Reports Completion of Patient Recruitment in Phase III Ulcerative Colitis Study (COLLECT) with Kappaproct®
InDex Pharmaceuticals today announced the completion of patient enrollment for its Phase III COLLECT study of Kappaproct. The multinational, randomized, double-blind, placebo-controlled study reached the recruitment goal of 120 patients with treatment-refractory Ulcerative Colitis (UC). InDex is expecting final study results in mid-2014.
The Phase III trial is designed to assess Kappaproct’s efficacy and safety in treatment-refractory UC patients. This cohort consists of chronic active UC patients who have failed all currently available pharmaceutical treatment and whose only remaining treatment option is surgical removal of the colon. This is a rare group of patients with a very high unmet medical need. Kappaproct has an Orphan Drug Designation in Europe.
The study is conducted in seven European countries. The primary endpoint of the study is the induction of clinical remission at week 12. Secondary endpoints, among others, are the rate of and time to colectomy. The patients will be followed for a total of 52 weeks.
Kappaproct is a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9). Kappaproct has shown positive effects on key symptoms of UC such as stool frequency, blood in stool and mucosal healing in a previous phase II proof-of-concept study. Kappaproct has also demonstrated a favorable safety and side effect profile in previous clinical trials.