Positive Results For InKine’s Cbp-1011 In Patients With Crohn’s Disease

announced positive results of its multicenter open-labeled, clinical trial of CBP-1011 in the treatment of patients with mild or moderate Crohn’s disease.

Key results of the study included* 80% of patients who completed the study responded to treatment with CBP-1011 using endpoints that were previously defined by the U.S. Food and Drug Administration (FDA) for a recently approved drug indicated for Crohn’s* 70% of the patients were in remission (CDAI less than or equal to 150) at the completion of the study.* 73% of the patients responded after 4 weeks, with a remission rate of 64%.

Martin Rose, M.D., J.D., Senior Vice President of Regulatory and Clinical Affairs at InKine commented: “The results of this Phase II clinical trial are encouraging … To put our results in perspective, published studies of currently marketed products for acute flares of Crohn’s disease have produced remission rates ranging from 25% to 80%.”

Further details–Patients with an established diagnosis of Crohn’s disease, currently taking medications such as aminosalicylates, cyclosporine, 6-mercaptopurine, azathioprine and/or systemic coritcosteroids (less than or equal to 20 mg/day), and experiencing increased gastrointestinal symptoms confirmed by a baseline Crohn’s Disease Activity Index (CDAI) between 200 and 400 were eligible to receive CBP-1011 tablets in a loading dose of 4 grams per day for the first two days followed by a daily maintenance dose of 1000 mg (500 mg every 12 hours) for up to 2 months.

Ninety one percent (10 of 11) of patients completed 2 months of treatment and 1 additional patient remains on therapy and is included in the 4-week analysis.

Of the 12 patients enrolled, only 1 patient discontinued therapy, and this was due to “fatigue.”

InKine Pharmaceutical Company, Inc. is a publicly-traded biopharmaceutical company focused on the diagnosis and treatment of cancer and autoimmune diseases.

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