CNS is Our Singular Focus

CATALYST TO ACCESS

ACULYS serves patients’ unmet needs through improved access to innovative CNS medicines.

ACULYS is a private biopharma company focused on the development and commercialization of innovative, best-in-class therapeutics. We specialize in CNS and are committed to helping patients in Japan who are suffering from debilitating neurologic diseases improve their quality of life.

The Problem

Sleep disorders results in severe health consequences for patients and significant economic loss for society.

Narcolepsy is a chronic neurologic sleep disorder that impacts the brain’s ability to control sleep-wake cycles. The primary symptom is “excessive daytime sleepiness.”. In addition, as a result of the fact that narcolepsy often occurs along with other disorders, and there is a general low level of public awareness of disease, narcolepsy is highly underdiagnosed in Japan.

Pharmacological therapies for sleep disorders are limited in Japan, and we believe there is significant room for improvement for new treatments that offer greater efficacy and safety.

Associated symptoms with sleep disorders include memory loss, poor concentration, depression and anxiety, often resulting in psycho-social impairments on relationships, academic performance, professional success and leisure activities. ​

The impact of sleep deprivation on Japanese society is enormous. Research shows decreased productivity at work and absence or sick leave due to lack of sleep cause an economic loss of about 3% of Japanese GDP, equivalent to about 15 trillion yen 1)
1) RAND Corp. report 2016
https://www.rand.org/pubs/corporate_pubs/CP1-2016.html

Patients with refractory epilepsy and their caregivers are anxious about seizures, not knowing when or where they will occur

Epilepsy is a condition in which repetitive seizures are triggered by the overactivity of nerve cells in the brain (epileptic seizures)1) Medical advances have made it possible to control seizures in many patients, allowing them to lead a normal social life without hindrance. In many cases, treatment is no longer necessary. However, there are patients with refractory epilepsy who continue to have seizures despite treatment with antiepileptic drugs. Misconceptions and fear about epilepsy and seizures have stigmatized this disease, which causes social issues in Japan.

1) NCNP Hospital National Center of Neurology and Psychiatry
https://www.ncnp.go.jp/hospital/patient/disease17.html (as of January 2023)

There are an estimated 300,000 patients with refractory epilepsy in Japan who have difficulty in completely controlling their seizures despite treatment with antiepileptic drugs and other therapies.2)3)
2) Epidemiological study on the prevalence of epilepsy and analysis of actual medical treatment status and improvement of treatment system_2013​
3) Early identification of refractory epilepsy; N Engl J Med 2000 Feb 3;342(5):314-9.

While understanding of epilepsy is improving, many people lack accurate information on the condition and its causes, in addition to how to respond when seizures occur.4)
4) From the Epilepsy Association of Japan Public Opinion Survey on Epilepsy 2013. 
https://www.jea-net.jp/

About one half of caregivers believe that people around them are uncomfortable because of epilepsy. A solution is needed for patients as well as caregivers 5) 6)
5) Epilepsy and social identity: the stigma of a chronic neurological disorder Lancet Neurol. 2005 Mar;4(3):171-8.
6) Have attitudes toward epilepsy improved in Germany over the last 50 years? Epilepsy Behav. 2022 Nov 29;138:108982.

The Solution​

Our approach is to address the social issues related to neurological and psychiatric disorders by building a comprehensive ecosystem that transcends the boundaries of pharmaceuticals.

Singular focus neurology

We are a clinical stage biopharmaceutical company focused on neurological and psychiatric disorders, where there is a high unmet medical need.

Accelerator model to address Japan’s drug lag

By working with innovative medicines that are already approved in the US or EU, we are able to skip many initial-stage hurdles, helping us to rapidly introduce treatments to the Japanese market.

“Beyond-the-pill” comprehensive support system for patients

Through collaboration with external partners and the use of AI and digital technology, we are developing multi-faceted programs, leveraging tools such as smartphones and wearable devices to monitor changes in patient medical conditions, enabling early detection of other potential conditions or comorbidities.

Leadership team with outstanding knowledge, experience, and dedication

Our experienced team members, who have contributed to the growth of major global pharmaceutical companies, are combining their knowledge and expertise to achieve our mission of addressing the stigmas and social issues related to neurological and psychiatric disorders.

Pipeline

We are currently building a pipeline of three indications in the field of neurological and psychiatric diseases.
In order to meet the unmet needs of Japanese patients as quickly as possible, we have begun development of drugs that have already been approved for use overseas but not yet approved in Japan.

Aculys Pharma Initiates a Phase 3 Trial of pitolisant Treating Patients with Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea Syndrome

Minato-ku, Tokyo, Japan, January 24 2023 — Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, announced the initiation of a phase 3 clinical study of pitolisant (), a histamine H3 receptor antagonist/inverse agonist in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS), in Japan This trial is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study (Part 1) and a subsequent multi-center, open-label, long-term extension study (Part 2) to assess the safety and efficacy of pitolisant in the Japanese patient population. ―― Additional study details can be found

Aculys Pharma and Four H Initiate Research Collaboration using Wearable Devices to Study Sleep Disorders in Japan

Using digital biomarkers to assess patients’ sleep and daytime activity Research could result in a more multifaceted and higher-quality approach to evaluating treatment efficacy Sleep disorders represent an unmet medical need in Japan, including serious co-morbidities, quality of life, and social issues Tokyo, Japan, January 24, 2023 — Aculys Pharma, Inc. (“Aculys”), a company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, and Four H, Inc. (“Four H”), a Japan- based company specializing in health technology, announced an exploratory research collaboration using wearable devices to help patients with narcolepsy and excessive

Aculys Pharma initiates a phase 3 clinical study of a diazepam nasal spray: an antiepileptic drug for the treatment of epileptic seizures

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 initiated a phase 3 clinical study of a diazepam nasal spray (compound development code: NRL-1), an antiepileptic drug for the treatment of status epilepticus or epileptic seizures that may lead to status epilepticus.  This phase 3 study, conducted in Japan, is a multi-center, open-label study in children with status epilepticus and those at risk for status epilepticus to assess the efficacy and safety

Aculys Pharma initiates a phase 3 clinical study of the histamine H3 receptor antagonist/inverse agonist pitolisant in patients with narcolepsy in Japan

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 initiated  a phase 3 clinical study of the histamine H3 receptor antagonist/inverse agonist pitolisant for the treatment of narcolepsy in Japan. This phase 3 study consists of a multi-institutional double-blind, randomized, placebo-controlled, parallel group-comparison study (Part 1) and an open-label long-term treatment study (Part 2) to assess the efficacy and safety of pitolisant. Please visit the following site for detailed information on the

Aculys Pharma has entered into a comprehensive collaboration agreement with KNOCK ON THE DOOR to solve social issues related to recurrent epileptic seizures

– 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