Minato Ward, Tokyo–(business wire)– Aculys Pharma, Inc. (“Aculys”), a clinical-stage biopharmaceutical company focused on commercializing innovative treatments for neurological disorders, is a histamine H3 receptor antagonist/inverse agonist announced the start of a Phase 3 clinical trial in Japan of the drug pitrisant. In patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS).
This study consisted of a multicenter, randomized, double-blind, placebo-controlled, parallel-group study (part 1) and a subsequent multicenter, open-label, long-term extension study (part 2) to assess safety. ) am. Efficacy and effectiveness of Pitrizant in a Japanese patient population. Additional research details here: https://jrct.niph.go.jp/latest-detail/jRCT2031220501
Aculys has an exclusive license to develop and commercialize Pitrisanto in Japan. Developed by Paris-based Bioprojet, Pitolisant was approved by the European Medicines Agency (EMA) for the treatment of excessive daytime sleepiness associated with OSAS in 2021 and has since been available in clinical settings. It is
OSAS is characterized by interruption of proper breathing due to narrowing or obstruction of the upper airway during sleep. Typical symptoms include loud snoring, daytime sleepiness, insomnia, deep sleep, and general malaise. If OSAS is not properly treated, patients may develop complications such as diabetes, depression, hypertension, arteriosclerosis, and other cardiovascular diseases in the medium to long term.1,2.
Continuous positive airway pressure (CPAP) is considered the standard of care for OSAS and is used to relieve upper airway narrowing and obstruction, contributing to various OSAS symptoms and improving patient quality of life. is known. However, some patients have been reported to experience persistent excessive daytime sleepiness despite adequate baseline therapy.3Excessive daytime sleepiness is thought to affect labor productivity, reduce quality of life, and be a risk factor for accidents such as traffic accidents.FourTherefore, new treatment options are needed.
Acuris Pharma aims to deliver this drug to OSAS patients in Japan as soon as possible, and to contribute to the realization of a society in which OSAS patients and their families can maximize their potential.
Pitolisant is an antagonist/inverse agonist that selectively binds to histamine H3 receptors. The histamine H3 receptor is an autoreceptor located in the presynaptic region of histamine-containing neurons in the human brain and plays an important role in regulating sleep-wake rhythms. The drug, created by Paris-based Bioprojet, will be used for the treatment of narcolepsy with or without cataplexy in 2016 and excessive daytime exposure associated with obstructive sleep apnea syndrome (OSAS) in 2021. approved by the European Medicines Agency (EMA) for the treatment of drowsiness in In the United States, it 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.
About Acrys Pharma
Aculys Pharma is a clinical-stage biopharmaceutical company focused on commercializing neurological innovations for patients in Japan. Aculys was founded in 2021 to facilitate access to neurological innovation. We are working to shorten the drug lag in Japan by developing and commercializing new central nervous system drugs. Reduce time to market by applying blockchain and AI technology. We provide services that improve healthcare for patients, their families, healthcare professionals, and society.
Company name: Acrys Pharma Co., Ltd.
Address: 2-14-4 Kita-Aoyama, Minato-ku, Tokyo
Representative: Issei Tsunaba
Established: January 2021
Information regarding pharmaceuticals (compounds under development) contained herein is not intended to be advertising or medical advice, but for business disclosure purposes.
The Japanese Circulation Society.JCS Joint Working Group for Guidelines for Diagnosis and Treatment of Cardiovascular Disease (2008-2009 Collaborative Research Team Report) Guidelines for Diagnosis and Treatment of Sleep Disordered Breathing in Cardiovascular Disease
Sleep Apnea Syndrome (SAS) Clinical Practice Guidelines 2020 (Edited by the Committee for Creating Sleep Apnea Syndrome (SAS) Clinical Practice Guidelines)
Update on persistent excessive daytime sleepiness in OSA. chest . 2020 Aug;158(2):776-786.
The economic and social burden of excessive daytime sleepiness in patients with obstructive sleep apnea. Sleep Med Rev. 2020 Jun;51:101275.