EA Pharma Co., Ltd. and Mochida Pharmaceutical Co., Ltd. announce the results ofphase 3 study of AJG533 for chronic constipation conducted in Japan– Primary endpoint was met in patients with chronic constipation
September 30, 2016
EA Pharma Co., Ltd.
Mochida Pharmaceutical Co., Ltd.
EA Pharma Co., Ltd. (President, Hajime Shimizu; Headquarters, Tokyo, Japan) and MochidaPharmaceutical Co., Ltd. (President, Naoyuki Mochida; Headquarters, Tokyo, Japan) announced
that the achievement of primary endpoint was met in Phase 3 clinical study of AJG533(nonproprietary name: Elobixibat Hydrate), which the two companies have developed for treatmentof chronic constipation in Japan.
Constipation is a very common disease, and the prevalence is particularly high in women and theelderly. In constipation, symptoms such as sensation of incomplete evacuation and hard stools
appear in addition to reduction of bowel movement frequency. When such symptoms become
chronic, many patients suffer from decline of QOL (quality of life). AJG533, which was in-licensed
from Albireo (Sweden), is an orally available constipation treatment having a novel action
mechanism. AJG533 inhibits the bile acid transporter that regulates reabsorption of bile acids andthereby increases spontaneous colonic motility.
The present phase 3 study is a double blind comparative study in Japan. Patients were randomized
to receive AJG533 or placebo orally once daily for 14 days for investigation of efficacy and safety.
The study results demonstrated a statistically significant improvement in the AJG533 group ascompared to the placebo group in the primary endpoint of spontaneous bowel movement1)
frequency change and also in the efficacy secondary endpoints including complete spontaneous
bowel movement2) frequency change and stool consistency. There were no serious adverse eventsin the study.
A long term study of AJG533 for investigation of safety and efficacy in long term use is now being
conducted.
EA Pharma Co., Ltd. and Mochida Pharmaceutical Co., Ltd. are advancing the development ofAJG533 with the aim of filing a new drug application in FY2016. By providing AJG533, the twocompanies are striving to make a further contribution to increasing treatment options andimprovement of QOL for patients with chronic constipation.
1) defacation without use of laxative, enema or manual disimpaction2) spontaneous defacation without sensation of incomplete evacuation

More information
1. About EA Pharma Co., Ltd.
EA Pharma Co., Ltd. is a gastrointestinal specialty pharma having a full value chain of researchand development, production and logistics, sales and marketing, established in April 2016 byintegration of the gastrointestinal business unit with more than 60 year-history of the Eisai Groupand the Ajinomoto Group’s gastrointestinal business unit with the core in amino acid.
Please see http://www.eapharma.co.jp/ for more information about EA Pharma Co., Ltd.
2. About Mochida Pharmaceutical Co., Ltd.
Mochida Pharmaceutical Co., Ltd. has committed to research and development of innovative
pharmaceutical products since its establishment thereby providing distinctive medicines to themedical field. Currently, the core pharmaceutical business focuses resources on the targetedareas of cardiovascular medicine, obstetrics and gynecology, dermatology, emergency medicine
and psychiatry, while also providing medicine for intractable disease as well as generics
including biosimilars, to meet medical needs.
Please see http://www.mochida.co.jp/ for more information about Mochida Pharmaceutical Co.
Ltd.