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Phase 2a Clinical Study Data of AJM300, Oral alpha 4 Integrin Antagonist, in Ulcerative Colitis Presented in DDW2014

May 13, 2014

- This Is First Study to Demonstrate Clinical Benefit of Oral alpha 4 Integrin Antagonist in Patient with Inflammatory Bowel Disease -

TOKYO, May 13, 2014 /PRNewswire/ — 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                   A multicenter,
     design                  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                 Improvement rate at 8
     endpoint                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.

Contact:
Hajime Ito
Corporate Planning Dept.
Ajinomoto Pharmaceuticals Co., Ltd.
Tel: +81-3-6280-9802
e-mail: contact_ajis@ajinomoto.com

SOURCE Ajinomoto Pharmaceuticals Co., Ltd.


Source: PR Newswire



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