Takeda has announced promising topline results from a Phase 2b trial evaluating TAK-861, an oral orexin receptor 2 (OX2R) agonist, for patients with narcolepsy type 1 (NT1). The randomized, double-blind, placebo-controlled trial showed that TAK-861 led to significant and clinically meaningful improvements in wakefulness and reductions in cataplexy rates compared to placebo.

The NT1 trial demonstrated that TAK-861 notably improved the Maintenance of Wakefulness Test (MWT) scores, Epworth Sleepiness Scale (ESS) scores, and Weekly Cataplexy Rate (WCR), indicating its potential as an effective treatment for NT1. Based on these results, Takeda now plans to initiate global Phase 3 trials for TAK-861 rapidly within the first half of the fiscal year 2024.

Concurrently, Takeda has decided not to advance TAK-861 for narcolepsy type 2 (NT2) at this time and is analyzing data for next steps in populations with normal levels of orexin, such as in NT2 and other indications where orexin biology plays a role. Multiple orexin agonists are in progress for other patients with normal orexin levels.

The trial also found TAK-861 to be generally safe and well-tolerated, with no treatment-related serious adverse events, hepatotoxicity, or visual disturbances reported. The safety profile and positive outcomes of TAK-861 could signify a breakthrough in addressing the underlying pathophysiology of narcolepsy type 1. Results from the study will be presented at an upcoming scientific congress.

Takeda recognizes the contributions of patients, caregivers, and investigators involved in the orexin agonist trials and remains committed to leveraging a deep understanding of orexin biology to develop and deliver transformative treatments for various indications connected to this mechanism.

Source link: http://www.businesswire.com/news/home/20240208344780/en/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

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.