InDex Pharmaceuticals, a Swedish biopharmaceutical company, has completed 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 being 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.
“This is a significant achievement for InDex Pharmaceuticals and we thank everyone involved in the study,” saidJesper Wiklund, CEO of InDex Pharmaceuticals. “It was encouraging to observe an exponential increase in the recruitment rate in the study so that we completed patient recruitment in less than one year. Considering the fact that this is a small patient population, the fast recruitment rate is a sign of enthusiasm for the study among investigators, patients and other stakeholders in the medical community. This enthusiasm bodes well for the future as we evaluate the optimal way to bring Kappaproct to approval and to market. If the encouraging results from the previous studies are confirmed in COLLECT, we trust that Kappaproct can become an effective new treatment for patients with treatment-refractory UC.”
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.