Takeda will present additional data from phase 2b and long-term extension trials of its investigational orexin receptor 2 agonist, TAK-861.

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Summary: Takeda will present new data from its phase 2b and long-term extension studies of TAK-861, an investigational oral orexin receptor 2 agonist, at Sleep Europe 2024. The trials focus on treating narcolepsy type 1 by addressing orexin deficiency, with positive results leading to the initiation of a global phase 3 trial. Takeda will present findings on TAK-861’s effects on cognitive impairment, nocturnal sleep quality, sustained attention, and long-term safety. The data contribute to a growing body of research supporting TAK-861 as a potential new treatment standard for narcolepsy.

Key Takeaways:

1. Takeda will present phase 2b and long-term trial data on TAK-861 at Sleep Europe 2024.
2. TAK-861 targets orexin deficiency in narcolepsy type 1 and has shown promising results in improving cognitive impairment and sleep quality.
3. A global phase 3 trial, FirstLight, has been initiated to further evaluate TAK-861’s efficacy and safety in narcolepsy type 1.

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Takeda will present additional data from the phase 2b trials (TAK-861-2001, TAK-861-2002) and long-term extension study (TAK-861-2003) of TAK-861 in narcolepsy type 1 and narcolepsy type 2 at Sleep Europe 2024, being held Sept 24-27 in Seville, Spain. 

TAK-861 is an investigational oral orexin receptor 2 (OX2R) selective agonist designed to address the orexin deficiency in narcolepsy type 1 by selectively stimulating the orexin receptor 2. TAK-861 has received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 from the US Food and Drug Administration (FDA).

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 narcolepsy type 1.

Podium and Poster Presentations

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 long-term extension 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,” says Elena Koundourakis, head, orexin franchise development and neuroscience programs and portfolio strategy at Takeda, in a release. “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 [narcolepsy type 1] 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 narcolepsy type 1. 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.