- This Is First Study to Demonstrate Clinical Benefit of Oral alpha 4

Integrin Antagonist in Patient with Inflammatory Bowel Disease -

Ajinomoto Pharmaceuticals Co., Ltd. (President, Takashi Nagamachi; Headquarters, Tokyo, Japan) announced on May 13 that the Phase 2a results of an oral alpha 4 integrin antagonist, AJM300, in patients with ulcerative colitis were presented in the Joint Presidential Plenary Session at Digestive Disease Week (DDW) 2014 held May 3 - 6 in Chicago, IL, USA.

In inflammatory bowel disease including ulcerative colitis, excessive infiltration of lymphocytes into the inflamed lesion is known to be associated with the disease progression. AJM300 has a new mode of action that prevents the adhesion and invasion of lymphocytes mainly to the inflamed lesion.

Dr. Mamoru Watanabe, Professor of Gastroenterology and Hepatology, Tokyo Medical and Dental University, who is the presenter of the above, says, "The clinical study data suggests that AJM300 can be a promising new treatment option for patients with ulcerative colitis who are not satisfied with current conventional therapies." He also says, "AJM300 has an advantage of orally available medicine. I look forward to the day when a Japan-origin new drug contributes to treatment of inflammatory bowel disease in the world."

Overview of presentation

Purpose         The purpose of the present study was to investigate for

                    efficacy and safety of AJM300 orally administered 3 times

                    a day at 960mg/dose for 8 weeks in patients with active

                    ulcerative colitis

Study design  A multicenter, randomized, double-blind, placebo-controlled,

                    parallel group phase 2a clinical study

Patients         Patients with moderately active ulcerative colitis who had

                    inadequate response or intolerance to 5-aminosalicylic

                    acid preparations or steroids, or who were not able to

                    continue treatment with such agents due to side effects

                    (n=102)

Primary endpoint  Improvement rate at 8 weeks

Results          - The clinical response rates (primary endpoint) were 62.7%

                    in AJM300 group and 25.5% in placebo group. There were

                    statistically significant improvements (p=0.0002).  

                    - The clinical remission rates (secondary endpoint) were

                    23.5% in AJM300 group and 3.9% in placebo group

                    (p=0.0099). The mucosal healing rates were 58.8% in

                    AJM300 group and 29.4% in placebo group (p=0.0014).

                    There were statistically significant improvements in

                    AJM300 group, respectively.

                    - AJM300 was well tolerated. No severe adverse events or

                    no severe infections were observed. Abnormalities in

                    laboratory test results tended to be increased in AJM300

                    group, but all the changes were mild and the symptoms

                    ameliorated without any additional treatments.