Takeda Delivers Positive Narcolepsy Study Results at SLEEP 2024

Pharmaceutical company, Takeda (NYSE: TAK) has announced that it will present positive results from its Phase 2b trial of TAK-861 in narcolepsy type 1 (NT1) as a late-breaking data presentation at SLEEP 2024. SLEEP 2024 is the annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society.

Takeda says that TAK-861, an investigational oral orexin receptor 2 (OX2R) agonist, has the potential to provide transformative efficacy in addressing the disease burden in people with NT1​.

Takeda’s randomized, double-blind, placebo-controlled, multiple dose trial in 112 patients with NT1 demonstrated statistically significant and clinically meaningful improvements across primary and secondary endpoints, with efficacy sustained over 8 weeks of treatment.

Commenting on the study, Sarah Sheikh, M.D., M.Sc., B.M., B.Ch., MRCP, Head, Neuroscience Therapeutic Area Unit and Head, Global Development at Takeda, said, “In this trial, TAK-861’s profile balanced efficacy and safety with the potential to establish a new standard of care for people with NT1. We are dedicated to investigating the full potential of orexin biology and advancing TAK-861 to late-stage clinical trials, with the ultimate goal of delivering a potential first-in-class treatment that can make a meaningful difference for patients.”

NT1 is a chronic, rare neurological central disorder with debilitating symptoms including excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, hallucinations and sleep paralysis. These symptoms lead to reduced quality of life and can have severe impacts on job performance, academic achievement and personal relationships.

Takeda plans to initiate global Phase 3 trials of TAK-861 in NT1 in the first half of its fiscal year 2024. The Phase 2b data also supported the recent Breakthrough Therapy designation for TAK-861 for the treatment of EDS in NT1 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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Takeda Delivers Positive Narcolepsy Study Results at SLEEP 2024

Catie Corcoran

Biotech Editor