Phase 2 study of Cobiprostone for prevention of NSAID-induced GI injuries

Sucampo reported top-line results from its Phase 2 trial of orally administered cobiprostone for the prevention of gastric ulcers and other gastrointestinal injuries in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs).  This 12-week, double-blinded, randomized, dose-ranging and placebo-controlled phase trial evaluated 124 patients being treated with 500 mg of naproxen twice daily for osteoarthritis and/or rheumatoid arthritis.  There were four treatment cohorts: one cohort received placebo while the other three cohorts received 18 mcg of cobiprostone either once, twice or three times a day (daily totals of 18, 36 or 54 mcg, respectively). Patients receiving cobiprostone experienced a lower overall incidence of ulcers: at Week 12, patients receiving the 54 mcg dose experienced a 50% reduction in the overall incidence of gastric ulcers compared to placebo. Cobiprostone patients experienced an overall statistically significant reduction in the number of gastric erosions through the treatment period of twelve weeks compared to placebo patients. The reduction of gastric erosions through Week 12 was dose dependent, with 36 mcg and 54 mcg demonstrating statistical significance. The time-to-onset of all ulcer or erosion development was delayed in the cobiprostone cohorts with overall statistical significance across the 12 week treatment period. The retention rates of patients taking naproxen with cobiprostone at Week 12 were statistically significant when compared to patients taking naproxen with placebo and increased in a dose-dependent manner. The rates were 40% for placebo vs. 47%, 52% and 77% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively. The median number of days in the treatment period was 55 days for patients taking placebo compared to 60, 82, and 83 days for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively. Overall, the data showed cobiprostone was well tolerated in patients receiving NSAID therapy as adverse event rates were comparable to placebo.   Withdrawal rates from the trial due to an adverse event were: 21.9% for placebo vs. 13.3%, 16.1% and, 16.1% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively.

Cobiprostone is a member of a class of compounds called prostones.  This functional fatty acid is a locally acting chloride channel activator with activity in the gastrointestinal tract.

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