The Phase III trial will enrol people whose daytime sleepiness has not improved after three months of nCPAP therapy. Credit: Gregory Pappas on Unsplash.

Aculys Pharma has commenced a Phase III clinical trial of pitolisant to treat people with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS), in Japan.

The Phase III clinical trial has been designed for evaluating the efficacy and safety of orally administered BF2.649 in Japanese OSAS patients who are complaining of EDS, despite receiving treatment by nasal continuous positive airway pressure (nCPAP).

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It includes a double-blind, randomised, parallel-group, multi-centre, placebo-controlled Part 1 study, and a subsequent, open-label, multi-centre, long-term extension Part 2 study.

The trial will enrol people diagnosed with OSAS, people whose daytime sleepiness have not been improved after three months of nCPAP therapy, who can continue to use nCPAP during the study, and whose ESS score is at least 12.

Developed by Paris-based Bioprojet, pitolisant is an antagonist/inverse agonist which selectively binds to the histamine H3 receptor.

The European Medicines Agency (EMA) approved the drug to treat narcolepsy with or without cataplexy in 2016 and to treat EDS associated with OSAS in 2021.

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The US Food and Drug Administration (FDA) has also approved pitolisant to treat EDS associated with narcolepsy in 2019 and cataplexy in 2020.

Biopharmaceutical company Aculys holds an exclusive license for the development and commercialisation of the drug in Japan.

It is focused on developing and commercialising innovative, best-in-class therapeutics for OSAS patients in Japan as early as possible.

In a separate development, the company announced an exploratory research collaboration with Four H using wearable devices to help patients with narcolepsy and EDS associated with OSAS in Japan.