Phase 2a Clinical Study Data of AJM300, Oral alpha 4 Integrin Antagonist

AJINOMOTO PHARMACEUTICALS — Tue, 13 May 2014 14:00:28 +0900

TOKYO, May 13 /Kyodo JBN/ --
Ajinomoto Pharmaceuticals Co., Ltd.
Phase 2a Clinical Study Data of AJM300,
Oral alpha 4 Integrin Antagonist,
in Ulcerative Colitis Presented in DDW2014
- 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.

Phase 2a Clinical Study Data of AJM300, Oral alpha 4 Integrin Antagonist, Will Be Presented in Diges

AJINOMOTO PHARMACEUTICALS — Wed, 16 Apr 2014 14:00:53 +0900

TOKYO, Apr. 16 /Kyodo JBN/ --
Ajinomoto Pharmaceuticals Co., Ltd.
Phase 2a Clinical Study Data of AJM300, Oral alpha 4 Integrin Antagonist, Will Be Presented in Digestive Disease Week 2014
Ajinomoto Pharmaceuticals Co., Ltd. announced on April 16 that the abstract of phase 2a clinical study data of an oral alpha 4 integrin antagonist, development code AJM300, has been accepted for presentation at the Digestive Disease Week 2014 (May 3 - 6 in Chicago, USA). The contents of data will be presented at the beginning of Joint Presidential Plenary Session collaborated by the American Society for Gastrointestinal Endoscopy and the American Gastroenterological Association.

- Study data to be presented (Presentation date/ time:USA Eastern time zone)

Abstract No.: 370
Title: AJM300, an Oral alpha 4 Integrin Antagonist, for Active
        Ulcerative Colitis: a Multicenter, Randomized, Double-Blind, Placebo-Controlled*
        Phase 2A Study
        Presentation date/ time: May 4, 2014, 1:36-1:46PM, Oral presentation

*Randomized double-blind, placebo-controlled study
Randomized double-blind, placebo-controlled study is a method of study to objectively evaluate the efficacy of medicine. In the study, neither investigators nor patients know which the patient takes a placebo (a mimic preparation that looks like a study drug but contains no active ingredient) or the study drug.

About Ajinomoto Pharmaceuticals Co., Ltd.
Representative Director,President & CEO: Takashi Nagamachi
Headquarters, Chuo-ku, Tokyo

Source: Ajinomoto Pharmaceuticals Co., Ltd.

法人別リリース

Phase 2a Clinical Study Data of AJM300, Oral alpha 4 Integrin Antagonist

Phase 2a Clinical Study Data of AJM300, Oral alpha 4 Integrin Antagonist, Will Be Presented in Diges