Tokyo, Japan, July 22, 2024 — Aculys Pharma, Inc. (“Aculys”), a clinical-stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announced that it has finished enrolling patients for the domestic Phase 3 clinical trial on the histamine H3 receptor antagonist/inverse agonist pitolisant in patients with narcolepsy.
Hidemasa Tanigaki, Chief Executive Officer of Aculys, said: “We are pleased to have completed patient enrollment for our Phase 3 trial on narcolepsy and to share this milestone. Currently, we are preparing for NDA submission. Aculys is committed to delivering pitolisant to narcolepsy patients with or without cataplexy in Japan as early as possible to enable a society where patients and their family can live their lives to the fullest potential.”
View details of the clinical trial at: https://jrct.niph.go.jp/latest-detail/jRCT2031220432
About narcolepsy
Patients with narcolepsy often start suffering from symptoms in childhood, adolescence, or young adulthood, but are not diagnosed until much later due to misdiagnosis, low awareness of the condition’s symptoms, or other reasons: The delay in diagnosis is a global challenge.1 The causes and pathophysiology of narcolepsy are largely unknown. In healthy people, neurotransmitters in the brain, such as orexin and histamine, help maintain the regular cycle of daytime wakefulness and nighttime sleep (REM and non-REM sleep), while in patients with narcolepsy, this sleep-wake cycle becomes irregular.2 Due to this irregular sleep-wake cycle, patients with narcolepsy suddenly, and against their will, fall asleep or have difficulty maintaining concentration while engaged in school or work. Some patients also have cataplexy attacks, which are a sudden loss of muscle tone of the whole body or certain voluntary muscles that are triggered by strong emotions, hypnagogic hallucinations (a hallucination that occurs right before falling asleep), and sleep paralysis (“old hag” syndrome). Different patients experience different types and severity of symptoms, but these symptoms significantly affect the patients’ lifestyles, including challenges in education or employment.3
About pitolisant
Pitolisant is an antagonist/inverse agonist that selectively binds to the histamine H3 receptor, an autoreceptor located in the presynaptic region of the histamine-containing neurons in the human brain that plays a critical role in regulating sleep and wake rhythm. The drug was discovered by Paris-based Bioprojet and was approved by the European Medicines Agency (EMA) for the treatment of narcolepsy with or without cataplexy in 2016 and for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea syndrome (OSAS) in 2021. In the United States, the drug was approved by the Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness associated with narcolepsy in 2019 and cataplexy associated with narcolepsy in 2020 and is already used in the clinical setting. As of the end of 2023, Pitolisant has obtained regulatory approval in 38 countries including US and EU for narcolepsy, and in 30 countries in EU for OSAS.
About Aculys Pharma, Inc.
Aculys Pharma is a clinical stage biopharmaceutical company that is pioneering ways to eliminate drug lag/drug loss in Japan, and is working to resolve social issues related to neurological and psychiatry diseases. Its corporate name was created from the philosophy of serving as a “Catalyst to Access.” Aiming 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: Hidemasa Tanigaki
Established: January 2021
URL: https://aculys.com
Information concerning pharmaceutical products (compound under development) contained herein is not intended as advertising or as medical advice but for disclosure of management information.
References:
- Thorpy MJ, Krieger AC. Delayed diagnosis of narcolepsy: characterization and impact. 2014 May;15(5):502-7.
- Scammell TE. Narcolepsy. NEJM. 2015;373:2654-2662.
- Scammell TE, Jackson AC, Franks NP, Wisden W, Dauvilliers Y. Histamine: neural circuits and new medications. Sleep. 2019 Jan 1;42(1):zsy183.