Clinical trial: oral colon‐release parnaparin sodium tablets (CB‐01‐05 MMX®) for active left‐sided ulcerative colitis

Aliment Pharmacol Ther 31, 375‐386

Summary

Background The administration of parnaparin sodium as oral colon‐release tablets (CB‐01‐05 MMX^®) has been proposed as a novel approach for the treatment of ulcerative colitis (UC). Aim To assess the efficacy and the tolerability of 8 weeks’ oral daily administration of 210 mg of parnaparin sodium compared with placebo in subjects treated with stable‐doses of oral aminosalicylates. Methods This multicenter, randomized, double‐blind proof of concept trial compared the efficacy of CB‐01‐05 MMX^® 210 mg tablets to placebo in 141 subjects with mild to moderately active left‐sided UC treated with stable‐doses of aminosalicylates. The efficacy was assessed by clinical activity index (CAI), endoscopic index (EI) and histological score (HS). Results A total of 121 subjects (61 in test group and 60 in control group) formed the per protocol (PP) population. After 8 weeks of treatment, clinical remission was achieved in 83.6% of the CB‐01‐05 MMX^® group, and in 63.3% in the comparator group (P = 0.011). This effect was also significantly evident in the test group at week 4 (P = 0.028). A significant difference was also detected in rectal bleeding, (disappeared respectively in 75.4% and 55.0%; P = 0.018), and in mucosal friability (recovered respectively in 80.3% and in 56.7%; P = 0.005). Conclusions CB‐01‐05 MMX^® was safe and significantly effective in treating subjects with mild‐to‐moderate left‐sided UC treated with stable‐doses of aminosalicylates.