– Initiating digital transformation (DX) in clinical trial and joint research utilizing real-world data –
Aculys Pharma, Inc. (“Aculys Pharma” Headquarters: Minato-ku, Tokyo; Representative Director and CEO: Kazunari Tsunaba), a company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, announced that it has entered into a comprehensive collaboration agreement with KNOCK ON THE DOOR, Inc. (“KNOCK ON THE DOOR” Headquarters: Shinjuku-ku, Tokyo; Representative Director: Yasuomi Hayashi), to resolve social issues related to epileptic seizures.
It is said that 0.6 to 1 million people or 5 to 8 in 1000 people suffer from epilepsy* in Japan. With advancements in medical care, many patients with epilepsy are able to take control of their seizures and lead normal social lives by being appropriately diagnosed and treated with anti-epileptic drugs or other treatments. However, about 30 percent of patients are not able to adequately control their seizures- placing a burden on their families/caregivers to have to respond to recurrent seizures1,2.
The cause, symptoms, and severity of epileptic seizures varies widely among patients, and epileptic seizures themselves exhibit diverse characteristics in each patient. Among the diverse seizure types, there are cases in which patients experience seizures that recur many times a day or that do not terminate after a certain period of time. These patients are at an increased risk of brain damage and experiencing a negative impact on their prognosis. Therefore prompt therapeutic interventions are necessary3. However, current mainstream practice, for such patients, has been inefficient, with long ambulance transport times to get them to a medical institution for treatment. On average, it takes 40 minutes from the time a call is placed until the patient is treated with medications by healthcare professionals3. An extensive overseas survey of patients, their families, and physicians reports that recurrent epileptic seizures cause significant emotional, social, and financial burden, not only on patients, but also on their families4.
To realize a society in which patients with recurrent epileptic seizures, along with their families/caregivers can lead their lives without worries, Aculys Pharma is preparing for the development of diazepam intranasal spray in Japan to provide a means to respond to seizures outside of medical institutions5. Aculys Pharma is also striving to facilitate the creation of an ecosystem that enables communities to respond more rapidly to epileptic seizures by actively utilizing new technologies and services.
With an aim of improving epilepsy medical care, KNOCK ON THE DOOR provides a smartphone app, “nanacara”, co-developed with epilepsy patients, their families and physicians, to record medication compliance and seizure frequency. The app provides a platform service that allows users to record critical information easily and accurately for better medical care and to share it with physicians6.
Aculys has reached a comprehensive collaboration agreement with KNOCK ON THE DOOR as a partner in building an ecosystem. Through these collaborative efforts, KNOCK ON THE DOOR will develop and provide an e-diary app with specifications for the Aculys’ clinical trial to record information on seizures, physical conditions, and medication administration by the patient’s family. Aculys Pharma will leverage the know-how that KNOCK ON THE DOOR has to collect accurate and reliable data in a simplified manner.
In parallel with the clinical trial collaboration, the companies are planning to conduct research by using epileptic seizure-related real-world data, accumulated in nanacara, which has already been widely used in the field of epilepsy, to reveal the actual situation and problems around epileptic seizures in Japan, and to utilize the research findings to facilitate a better medical care system for patients with epileptic seizures.
Aculys will continue to contribute to the Japanese society by identifying healthcare issues from a social point of view and finding solutions through actively utilizing new technologies and developing external partnerships.
*Epilepsy is a chronic brain disorder in which excessive electrical excitation of nerve cells in the brain leads to symptoms (epileptic seizures) such as disturbed consciousness and seizures.
**A general term for data related to a patient’s health status and the delivery of health care routinely collected from various sources, including claims data, electronic medical records, health checkups, and patient registries. This study utilizes data from nanacara users who gave informed consent for purposes of information usage.
1 Study on Epidemiological Studies on the Prevalence of Epilepsy, Analysis of Practice and Development of Treatment System-2013
2 Kwan P, MJ Brodie. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314–9.
3 Guidelines for the Treatment of Pediatric Convulsions (Japanese Society for Pediatric Neurology) 2017.
4 Penovich PE, Buelow J, Steinberg, et al. Burden of seizure clusters on patients with epilepsy and caregivers survey of patient, caregiver, and clinician perspectives. The Neurologist. 2017;22:207–214.
■About KNOCK ON THE DOOR Inc.
KNOCK ON THE DOOR, Inc. is a venture company that provides platforms for epilepsy treatment” nanacara” and “nanacara for Doctor” under the philosophy of “making patients and their families the light of the world”. The company provides solutions for challenges surrounding the disease through collaboration with patients with intractable epilepsy, who often suffer rare diseases, and their families, to improve the quality of life of patients and their families.
Company name: KNOCK ON THE DOOR, Inc.
Address: 3F, 2-1 DS, Yahata-cho, Shinjuku-ku, Tokyo
Established in July 2018
■ About Aculys Pharma, Inc.
Aculys Pharma is a biopharmaceutical company focused on the development and commercialization of innovations in the fields of neurology and psychiatry. Its corporate name was created from the philosophy of “Catalyst to Access.” Aimed to act as a bridge for innovative medical care in the field of neuropsychiatry, Aculys Pharma develops and commercializes novel pharmaceuticals and provides innovations for better medical care to patients, their families, healthcare professionals, and society.
Company name: Aculys Pharma, Inc.
Address: 2-14-4 KitaAoyama, Minato-ku,Tokyo, Japan
Representative: Kazunari Tsunaba
Established: Jan 2021
Information concerning pharmaceutical product (compound under development) contained herein is not intended as advertising or as medical advice, but intended for disclosure of management information.
[Contact information for the press]
Aculys Pharma Public Relations Secretariat (within Brains Company, Inc.)
Assignment: Uka YOSO Tel: +81-3-4580-6124 Mail: firstname.lastname@example.org