Otsuka : Decision to continue phase III clinical trial evaluating brexpiprazole for treatment of agitation in patients with Alzheimer's-type dementia
April 13, 2021 at 02:03 am EDT
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For Immediate Release
April 13, 2021
Company name
Otsuka Holdings Co., Ltd.
Representative
Tatsuo Higuchi
President and Representative Director, CEO
Code number
4578 First Section , Tokyo Stock Exchange
Inquiries
Yuji Kogure
Director, Investors Relations Department
Otsuka and Lundbeck announce decision to continue phase III clinical trial evaluating brexpiprazole for treatment of agitation in patients with Alzheimer's-type dementia
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the decision to continue the recruitment of patients in the phase III clinical trial of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type. The decision to continue the trial is based on the results of an independent interim analysis, supporting to progress the trial to the planned full enrollment of 330 patients.
The continuation of the study enables us to further explore the efficacy of brexpiprazole to address the high medical need in patients suffering from agitation in Alzheimer's type dementia. Completion of the trial is expected in the first half of 2022.
About the study
The trial was designed to assess the safety, tolerability and efficacy of brexpiprazole in the treatment of patients with agitation in Alzheimer's dementia. The trial consisted of a 12-weekdouble-blind treatment period with a 30-dayfollow-up. The trial population was planned to include 330 male and female patients, aged 55 to 90 years (inclusive), with a diagnosis of probable Alzheimer's disease.
The primary outcome was the change in the CMAI total score. The key secondary outcome was the change in the Clinical Global Impression - Severity of Illness (CGI-S) score, as related to symptoms of agitation. Patients participating in the trial are from countries including Bulgaria, Hungary, Serbia, Slovakia, Spain, Ukraine, and the U.S. Approximately half of the participants are living at home and the rest are institutionalized.
As agreed with the FDA, an interim analysis conducted by an independent data monitoring committee assessed the efficacy on the CMAI total score, in accordance with pre-specified criteria when 255 subjects had completed the trial.
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Otsuka Holdings Co. Ltd. published this content on 13 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 April 2021 06:02:06 UTC.
Otsuka Holdings Co, Ltd. is a holding company organised around 4 areas of activity:
- manufacture and sale of pharmaceutical products (65.2% of sales): prescription drugs and intravenous solutions mainly for the treatment of central nervous system disorders, cancer, cardiovascular, gastrointestinal and ophthalmic diseases. In addition, the group sells diagnostic products and medical devices;
- manufacture and sale of nutraceutical products (25.1%): functional foods and beverages, OTC products, nutritional supplements;
- production of mineral waters, beverages and foods (2.1%);
- other (7.5%): manufacture of functional chemicals and fine chemicals, provision of logistics services, manufacture of electronic products, etc.
Net sales by source of income are divided between sales of products (93.8%), sales of licences and royalties (1.8%) and other (4.4%).
Net sales are distributed geographically as follows: Japan (43.2%), North America (34%),
OTSUKA HOLDINGS CO., LTD. 
