Takeda's orexin narcolepsy drug poised for Phase III after promising readout
03 Jun 2024
Clinical ResultPhase 2Phase 3
Takeda pulled back the curtain on a Phase IIb trial evaluating its investigational oral therapy TAK-861 for the treatment of narcolepsy type 1 (NT1). In February, the company said its orexin receptor 2 agonistorexin receptor 2 agonist showed statistically significant and clinically meaningful improvements versus placebo across primary and secondary endpoints in the 112-patient study.
The randomised trial assessed the impact of various doses of TAK-861 take once or twice daily on objective and subjective measures of wakefulness over an 8-week treatment period. The primary endpoint showed TAK-861 significantly increased mean sleep latency on the Maintenance of Wakefulness Test (MWT) at week 8 compared to placebo across all dose groups. Mean sleep latency ranged from 16.5 minutes for the lowest 0.5mg/0.5mg dose up to 30.7 minutes for the 2mg/5mg dose, compared to just 7 minutes for placebo.
Beefits were seen on key secondary endpoints as well. By week 8, between 66.7% and 95.2% of patients across the TAK-861 dose groups achieved an Epworth Sleepiness Scale (ESS) score ≤10, within the normative range, versus only 19% for placebo. TAK-861 also significantly reduced weekly cataplexy rates, with the twice-daily 2mg/2mg and 2mg/5mg doses reducing median rates down to just 0.7 events per week compared to 4.1 for placebo.
"The majority of NT1 patients in the trial were found to be within normative ranges for MWT and ESS by the end of the 8-week treatment period as a result of these sustained improvements," Takeda stated. The therapy was also generally well-tolerated, with no serious treatment-related adverse events or discontinuations due to adverse events.
Based on the mid-stage data, Takeda plans to advance TAK-861 into global Phase III trials for NT1 in the first half of fiscal year 2024.
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