Aculys Pharma Initiated a Phase 1 Clinical Trial of pitolisant, a histamine H3 receptor antagonist / inverse agonist, in Japan

Aculys Pharma, Inc. (“Aculys Pharma” Headquarters: Fujisawa City, Kanagawa Prefecture, Representative Director and CEO: Kazunari Tsunaba), a biopharmaceutical company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, announced that it has initiated a Phase 1 clinical trial of histamine H3 receptor antagonist / inverse agonist, pitolisant (development code: BF2.649) in Japan, and the first dose was administered successfully in January 2022.

Aculys Pharma has an exclusive licensing agreement for the clinical development and commercialization of pitolisant in Japan, and is developing the drug under development code BF2.649. The objective of this clinical trial is to confirm safety, tolerability and pharmacokinetics in healthy adult subjects.

Please refer to the registration information in the following link for details of this clinical trial.
https://jrct.niph.go.jp/latest-detail/jRCT2071210104

Beyond the development and commercialization of new medicines, Aculys is committed to the patient experience, including the awareness, screening, diagnosis, personalized treatment and resolution of surrounding social issues for patients and their families confronted with neurological and psychiatric disease. The company looks to form comprehensive solutions through cross-sectional partnerships using new technologies to enhance the patient experience.

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 approved by the EMA for “narcolepsy with or without cataplexy” in 2016 and for “excessive daytime sleepiness associated with obstructive sleep apnea syndrome” in 2021. In the United States, the drug was approved by the FDA for “excessive daytime sleepiness associated with narcolepsy” in 2019, and “cataplexy associated with narcolepsy” in 2020.

About Aculys Pharma, Inc.

Aculys Pharma is a biopharmaceutical company focused on the development and commercialization of innovations in the fields of neurology and psychiatry. Its corporate name was created from the philosophy of “Catalyst to Access.” Aimed to act as a bridge for innovative medical care in the field of neuropsychiatry, Aculys develops and commercializes novel pharmaceuticals and provides innovations for better medical care to patients, their families, healthcare professionals, and society.
http://www.aculys.com

Company name: Aculys Pharma, Inc.
Address: 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan
Representative: Kazunari Tsunaba
Established: Jan 2021

URL: https://www.aculys.com

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

[Contact information for the press]
Aculys Pharma Public Relations Secretariat (within Brains Company, Inc.)
Assignment: Uka YOSO Tel: +81-3-4580-6124
Mail: aculys_pr@pjbc.co.jp