Phase IIb success propels Takeda's narcolepsy asset into late-stage testing

2024-02-09

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Takeda announced plans to initiate Phase III studies for its oral orexin receptor 2 (OX2R) agonist TAK-861 in narcolepsy type 1 (NT1), following positive findings from a Phase IIb trial. Sarah Sheikh, head of global development, said the “clear and compelling results” enable the company to commence late-stage testing as early as the first half of fiscal year 2024.

The Phase IIb study, involving 112 patients with NT1, demonstrated statistically significant and clinically meaningful improvements in both objective and subjective measures of wakefulness for TAK-861 versus placebo at week 8. The primary endpoint, a maintenance of wakefulness test, was consistent with key secondary outcome measures, including the Epworth Sleepiness Scale and Weekly Cataplexy Rate. The drug was well tolerated, with no treatment-related serious adverse events.

Takeda, which also ran a Phase IIb trial of TAK-861 in narcolepsy type 2 (NT2), stated it had no intentions of advancing the candidate in this indication. Findings from both studies will be presented at an upcoming scientific conference.

Not all roses

Takeda’s orexin franchise encountered troubled waters in late 2021, when the Phase II programme for another oral OX2R agonist TAK-994 in NT1 and NT2 was axed after the emergence of a safety signal. The franchise also includes an investigational intravenous OX2R agonist TAK-925.

Sheikh remarked that the drugmaker will continue to leverage its “deep and growing understanding of orexin biology” to investigate multiple orexin agonists across a wide range of indications, including conditions with normal orexin levels such as NT2.

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