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

P>Background The administration of parnaparin sodium as oral colon-release tablets (CB-01-05 MMX (R)) 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 (R) 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 (R) 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 (R) was safe and significantly effective in treating subjects with mild-to-moderate left-sided UC treated with stable-doses of aminosalicylates.