Takeda to Present New TAK-861 Narcolepsy Data at Sleep Europe 2024
OSAKA, Japan & CAMBRIDGE, Mass.--Takeda (TSE:4502/NYSE:TAK) is set to disclose further findings from its Phase 2b trials (TAK-861-2001, TAK-861-2002) and long-term extension (LTE) study (TAK-861-2003) on TAK-861 for narcolepsy type 1 (NT1) and type 2 (NT2) at Sleep Europe 2024, held from September 24-27, 2024, in Seville, Spain. TAK-861 is an investigational oral orexin receptor 2 (OX2R) selective agonist aimed at addressing orexin deficiency in NT1 by targeting the orexin receptor 2. There is potential for TAK-861 to become the first treatment that tackles the root cause of NT1. Following positive results from Phase 2b trials, Takeda has launched the FirstLight Study, a global Phase 3 trial to evaluate the efficacy and safety of TAK-861 in adults with NT1.
Takeda’s presentations at the conference will feature a podium session focusing on TAK-861’s impact on cognitive impairment (Abstract No: 781) and several poster presentations exploring additional endpoints such as effects on nocturnal sleep quality and sustained attention. An interim safety and efficacy analysis from the ongoing LTE study will also be shared (Poster No: P1291).
Elena Koundourakis, head of orexin franchise development and neuroscience programs at Takeda, highlighted the significant impact narcolepsy has on daily life beyond daytime sleepiness and cataplexy. She emphasized that Takeda is a leader in orexin science and is committed to developing comprehensive clinical data on orexin agonists. Some patients have undergone up to one year of treatment within Takeda’s clinical studies. The data presented at Sleep Europe contribute to a broader understanding of orexin biology and the potential of TAK-861 to establish a new standard of care for NT1.
These presentations are expected to enhance the scientific community's understanding of OX2R agonists and their potential to redefine treatment outcomes for NT1 patients. Takeda continues to develop tailored treatments for sleep-wake disorders, including NT2 and idiopathic hypersomnia.
More information on the FirstLight Study, currently enrolling participants, is available at www.clinicaltrials.gov (identifier: NCT06470828) and www.firstlightstudy.com (for U.S. audiences only). Takeda currently has no approved therapies for narcolepsy.
Takeda’s Orexin Agonists for Sleep-Wake Disorders:
Takeda is pioneering orexin therapeutics with a portfolio of treatments designed to maximize the potential of orexin science. Orexin plays a crucial role in regulating the sleep-wake cycle and other essential functions, such as respiration and metabolism. TAK-861 is the flagship program in this portfolio and has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for treating excessive daytime sleepiness in NT1. Takeda is also exploring orexin agonists for patient populations with normal levels of orexin neuropeptides and other conditions where orexin biology is relevant. This includes TAK-360, an oral OX2R agonist in Phase 1 trials for NT2 and idiopathic hypersomnia, which recently received Fast Track designation from the FDA.
About Takeda:
Takeda is dedicated to improving health and delivering life-changing treatments across several therapeutic areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. As a leading R&D-driven biopharmaceutical company headquartered in Japan, Takeda is committed to patients and guided by its values, aiming to advance new treatment options through its diverse pipeline. The company operates in around 80 countries and regions, driven by its purpose and long-standing values.
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