Takeda intends to rapidly initiate the first global phase III trials of TAK 861, an oral orexin agonist, in narcolepsy type 1 in first half of fiscal year 2024.
Takeda announced positive topline results from a randomized, double-blind, placebo-controlled, multiple dose Phase IIb trial evaluating TAK 861, an oral orexin receptor 2 (OX2R) agonist, in patients with narcolepsy type 1
The NT1 trial TAK-861-2001 evaluating TAK 861 in 112 patients demonstrated statistically significant and clinically meaningful improvement in objective and subjective measures of wakefulness compared to placebo at week 8 including on the primary endpoint Maintenance of Wakefulness Test (MWT) (p < 0.001). Improvements in key secondary endpoints including Epworth Sleepiness Scale (ESS) and Weekly Cataplexy Rate (WCR) were statistically significant and clinically meaningful, consistent with the primary endpoint. The majority of patients who completed the trial entered a long-term extension study. TAK 861 was generally safe and well tolerated in both trials. No treatment related serious adverse events were reported. In addition, no cases of hepatotoxicity or visual disturbances were reported in the Phase IIb trials or in the ongoing TAK 861 long-term extension trial.
Takeda also conducted a Phase II trial (NCT05687916) of TAK 861 in patients with NT2; however, the company said it will not advance the treatment to Phase III for this indication.
Results from both trials will be presented at an upcoming scientific congress.
Takeda plans to initiate global Phase III trials of TAK 861 in NT1 rapidly in the first half of its fiscal year 2024 . At this time, Takeda does not plan to advance TAK 861 in NT2. Data are being further analyzed to determine next steps in orexin normal populations. Takeda is progressing multiple orexin agonists in patient populations with normal levels of orexin neuropeptides such as NT2 and other indications where orexin biology is implicated.
"The magnitude of the effects was quite striking with most subjects on each of the TAK 861 doses staying awake during all 4 of the 40-minute MWT sleep trials performed throughout the night; whereas only 1 participant did this while on placebo. TAK 861 also showed a favorable safety profile, with no instances of severe adverse events, fatalities, or treatment discontinuations because of adverse events reported. We are encouraged by these results, which have demonstrated the efficacy and safety of TAK 861 in the tested doses, both high and low, among the participants," according to investigator Melissa Naylor, MD, PhD, medical director of neuroscience at Takeda Development Center Americas.
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