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

Aculys Pharma, a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, announced the initiation of a phase 3 clinical study 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).

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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.

Aculys has an exclusive license to develop and commercialize pitolisant in Japan. Pitolisant, developed by Paris-based Bioprojet, 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 the clinical setting.

OSAS is characterized by an interruption of proper breathing due to the narrowing or obstruction of the upper airway during sleep. Typical symptoms include loud snoring, daytime sleepiness, insomnia, sense of insufficient deep sleep, and systemic fatigue. If OSAS is not properly treated, in the medium- to long-term, patients may develop complications such as diabetes, depression, hypertension, arteriosclerosis, and other cardiovascular conditions^1,2.

Continuous Positive Airway Pressure (CPAP) is considered the standard treatment in OSAS and is used to mitigate the narrowing and obstruction of the upper airway and is known to contribute to improving various OSAS symptoms and patients’ quality of life. However, some patients reportedly experience persistent excessive daytime sleepiness despite appropriate basic treatment³, and excessive daytime sleepiness is considered a risk factor for impact on labor 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 early as possible and aims to help achieve a society where people with OSAS and their family members live their lives to the fullest potential.

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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 created 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.

Aculys Pharma is a clinical stage biopharmaceutical company focused on the commercialization of neurology innovations for patients in Japan. Aculys was formed in 2021 as a catalyst to neurology innovation access. We are committed to shortening the drug lag in Japan by developing and commercializing novel CNS treatments; applying blockchain and AI technologies to increase speed to market; and providing services to improve medical care for patients, their families, healthcare professionals, and society.

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