Takeda’s oveporexton improved function, cognition and nighttime sleep in narcolepsy type 1

Key Phase 3 findings

Secondary and exploratory endpoints from the FirstLight and RadiantLight pivotal studies showed oveporexton improved daily functioning, cognitive symptoms and nighttime sleep in people with narcolepsy type 1. Functioning improved significantly at week 12 versus placebo across all six domains of the Functional Impacts of Narcolepsy Instrument (FINI) (p<0.001). Cognitive benefits were observed on objective neuropsychological tests of attention, executive function and memory and on patient-reported measures; approximately 70% of patients across doses reported no significant cognitive difficulties on the FINI Cognitive domain versus roughly 15% on placebo.

Nighttime and REM effects

Exploratory sleep endpoints indicated improved quality of sleep, with most patients reporting no hallucinations or sleep paralysis. Most patients on the 2/2mg dose reported meaningful reductions in disturbed nighttime sleep from baseline, and the timing and pattern of REM sleep shifted toward patterns seen in healthy controls.

Study design, enrollment and regulatory status

FirstLight (TAK-861-3001) randomized 168 participants across twice-daily 2mg, 1mg and placebo arms; RadiantLight (TAK-861-3002) randomized 105 participants across twice-daily 2mg and placebo. Both global, multicenter, placebo-controlled studies were conducted in 19 countries with enrollment completed within six months; more than 95% of completers joined the ongoing long-term extension. The U.S. FDA accepted the NDA and granted Priority Review with a PDUFA goal date in the third quarter; regulatory submissions are also under review in China and Japan with additional filings planned. Further conference data will include pooled Phase 3 analyses, microsleep reduction data and a holistic symptom impact evaluation in the U.S.