Positive Data on Oral Orexin Receptor 2 Agonist for Patients with Narcolepsy Type 1

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Takeda announced positive topline results from a randomized, double-blind, placebo-controlled, multiple dose phase 2b trial evaluating TAK-861, an oral orexin receptor 2 agonist, in patients with narcolepsy type 1.

“We are thrilled to announce these clear and compelling results from the TAK-861 trial in narcolepsy type 1 that allows us to rapidly initiate phase 3 trials this year as we work to deliver a medicine to patients that could address the underlying pathophysiology of the disease,” said Sarah Sheikh MSc, BM, BCh, MRCP, head of the Neuroscience Therapeutic Area Unit and Head for global development at Takeda.¹

Investigators evaluated 112 participants with narcolepsy type 1, aged 18 to 70. TAK-861 showed statistically significant and clinically meaningful improvement in measures of wakefulness compared with placebo at week 8, including on the primary endpoint Maintenance of Wakefulness Test (MWT) (p < 0.001). Key secondary endpoints were also met; improvements on Epworth Sleepiness Scale (ESS) and Weekly Cataplexy Rate (WCR) were statistically significant and clinically meaningful. Most of the study’s participants chose to enter the long-term extension study. TAK-861 was generally safe and well tolerated and no treatment-related serious adverse events were reported.

TAK-861 has the potential for Takeda to bounce back from a previously-stalled narcolepsy program, shared Elena Koundourakis, head of Takeda’s orexin franchise.²

Based on these results, Takeda plans to initiate global phase 3 trials of TAK-861 in narcolepsy type 1. Takeda also conducted a separate phase 2b study in narcolepsy type 2; however, Takeda does not plan to advance TAK-861 in narcolepsy type 2. Data are being further analyzed to determine next steps in orexin normal populations.

Takeda plans to share results from both trials at an upcoming scientific congress.

“Takeda thanks the patients, caregivers and investigators who participated in our orexin agonist trials. We will continue to apply our deep and growing understanding of orexin biology as we work to develop and deliver transformative treatments to people across a range of indications who could benefit from this mechanism,” said Sheikh.¹

References

1. Takeda intends to rapidly initiate the first global phase 3 trials of tak-861, an oral orexin agonist, in narcolepsy type 1 in first half of fiscal year 2024. News release. February 8, 2024. Accessed February 9, 2024. https://www.takeda.com/newsroom/newsreleases/2024/Takeda-Intends-to-Rapidly-Initiate-the-First-Global-Phase-3-Trials-of-TAK-861-an-Oral-Orexin-Agonist-in-Narcolepsy-Type%201-in-First-Half-of-Fiscal-Year-2024

2. Manalac T. Takeda pushes one narcolepsy program into phase III, discontinues another. BioSpace. February 9, 2024. Accessed February 9, 2024. https://www.biospace.com/article/takeda-pushes-one-narcolepsy-program-into-phase-iii-discontinues-another-/