Presentations Include New Data from the TAK-861-2001 Phase 2b Trial in Narcolepsy Type 1 Highlighting Impact on Daily Functioning Including Cognition and Sleep Quality

Data from Long-Term Extension Study will also be Presented

Phase 3 Trial of an Orexin Agonist for Narcolepsy Type 1 Now Enrolling Patients Globally

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) will present additional data from the Phase 2b trials (TAK-861-2001,TAK-861-2002) and long-term extension (LTE) study (TAK-861-2003) of TAK-861 in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society (ESRS), being held September 24-27, 2024 in Seville, Spain. TAK-861 is an investigational oral orexin receptor 2 (OX2R) selective-agonist designed to address the orexin deficiency in NT1 by selectively stimulating the orexin receptor 2. TAK-861 has the potential to be the first treatment to address the underlying pathophysiology of NT1. Based on the positive Phase 2b trial results, Takeda has initiated the FirstLight Study, a global Phase 3 trial evaluating the efficacy and safety of TAK-861 in adults with NT1.

Takeda’s scientific presentations will include a podium presentation highlighting the effect of TAK-861 on cognitive impairment (Abstract No: 781) along with several poster presentations from additional exploratory endpoints including impacts on quality of nocturnal sleep and sustained attention. An interim analysis of safety and efficacy from the ongoing LTE study (Poster No: P1291) will also be presented.

“People living with narcolepsy suffer from debilitating symptoms that significantly impact their daily life beyond excessive daytime sleepiness and cataplexy,” said Elena Koundourakis, head, orexin franchise development & neuroscience programs and portfolio strategy at Takeda. “As leaders in orexin science, we continue to develop one of the most extensive clinical datasets of orexin agonists, with some patients reaching one year of treatment within our clinical studies. The data we are presenting at Sleep Europe add to the body of orexin agonist data we are building to improve our understanding of orexin biology and the potential of our investigative study drug TAK-861 towards establishing a new standard of care for the NT1 community.”

These data presentations add to the scientific community's growing understanding of the potential of OX2R agonists in redefining treatment outcomes for patients with NT1. Takeda is continuing the development of tailored assets to address the needs of people living with sleep-wake disorders including narcolepsy type 2 and idiopathic hypersomnia.

More information on the FirstLight Study, which is currently enrolling, can be found at www.clinicaltrials.gov (identifier: NCT06470828) and www.firstlightstudy.com (for U.S. Audiences only). Takeda does not have any approved therapies for narcolepsy.

About Takeda’s Orexin Agonists for Sleep-Wake Disorders
Takeda is advancing the field of orexin therapeutics with a multi-asset franchise offering tailored treatments to unlock the full potential of orexin science. Orexin is a key regulator of the sleep-wake cycle and is involved in other essential functions, including respiration and metabolism. TAK-861 is the leading program in this franchise and received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 from the U.S. Food and Drug Administration (FDA). The company is also progressing orexin agonists in patient populations with normal levels of orexin neuropeptides and other indications where orexin biology is implicated. This includes TAK-360, an oral OX2R agonist being investigated for narcolepsy type 2 and idiopathic hypersomnia, which recently initiated a Phase 1 trial and received Fast Track designation from the FDA.

About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

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