Aculys Pharma Starts Phase 3 Trial with Pitolisant for the Treatment of Patients with Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea Syndrome


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MINATO-KU, TOKYO, Japan–(BUSINESS WIRE)–Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological disorders, announced the initiation of a Phase 3 clinical trial in Japan of pitolisant – a histamine H3 receptor antagonist/inverse agonist in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS).

This study is 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 the safety and efficacy of pitolisant in the Japanese patient population. Additional study details can be found here: https://jrct.niph.go.jp/latest-detail/jRCT2031220501

Aculys has an exclusive license to develop and market pitolisant in Japan. Pitolisant, developed by Paris-based Bioprojet, was approved by the European Medicines Agency (EMA) in 2021 for the treatment of excessive daytime sleepiness associated with OSAS and has since been available in the clinical setting.

OSAS is characterized by an interruption of proper breathing due to narrowing or obstruction of the upper airway during sleep. Typical symptoms are loud snoring, daytime sleepiness, insomnia, feeling of insufficient deep sleep and systemic fatigue. If OSAS is not properly treated, patients can develop medium to long-term complications such as diabetes, depression, hypertension, arteriosclerosis and other cardiovascular diseases1,2.

Continuous positive airway pressure (CPAP) is considered the standard treatment in OSAS and is used to reduce the narrowing and obstruction of the upper airway and is known to help improve various OSAS symptoms and the quality of life of patients. However, some patients experience persistent excessive daytime sleepiness despite appropriate baseline treatment3, and excessive daytime sleepiness is considered a risk factor for impact on work productivity, reduced quality of life and accidents such as traffic accidents4, so new treatment options are needed.

Aculys Pharma is committed to bringing this drug to patients with OSAS in Japan as soon as possible and strives for a society where people with OSAS and their family members can live their lives to the fullest.

About Pitolisant

Pitolisant is an antagonist/inverse agonist that selectively binds to the histamine H3 receptor, an autoreceptor in the presynaptic region of histamine-containing neurons in the human brain that plays a critical role in regulating sleep and wakefulness. The drug is made 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. 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.

About Aculys Pharma, Inc.

Aculys Pharma is a clinical-stage biopharmaceutical company focused on commercializing neurological innovations for patients in Japan. Aculys was founded in 2021 as a catalyst for access to neurology innovation. We are committed to reducing the drug backlog in Japan by developing and commercializing new CNS treatments; apply blockchain and AI technologies to increase speed to market; and providing services to improve medical care for patients, their families, caregivers and society.

Company Name: Aculys Pharma, Inc.

Address: 2-14-4 KitaAoyama, Minato-ku,Tokyo, Japan

Representative: Kazunari Tsunaba

Established: January 2021

URL: https://aculys.com

The pharmaceutical (compound under development) information contained herein is not intended as advertising or medical advice, but is intended for management information disclosure.

References:

  1. The Japanese Circulation Society. JCS Joint Working Groups for Guidelines for Diagnosis and Treatment of Cardiovascular Disease (2008-2009 Joint Research Team Report) Guidelines for Diagnosis and Treatment of Sleep Disorders Breathing in Cardiovascular Disease

  2. Clinical Practice Guidelines for Sleep Apnea Syndrome (SAS) 2020 (Edited by Committee Preparing Clinical Practice Guidelines for Sleep Apnea Syndrome (SAS)

  3. Update on persistent excessive daytime sleepiness in OSA; Chest . Aug 2020;158(2):776-786.

  4. The economic and societal burden of excessive daytime sleepiness in patients with obstructive sleep apnea. Sleep Med Rev. Jun 2020;51:101275.

Aculys Pharma Communications Office (within Cosmo Publication Relations Corporation) [email protected]

Mika Shirai, Aculys Pharma[email protected]

Source: Aculys Pharma, Inc.

Aculys Pharma Starts Phase 3 Trial with Pitolisant for the Treatment of Patients with Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea Syndrome

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