By Fineline Cube 
Japan-based Takeda Pharmaceutical (TYO: 4502, NYSE: TAK) announced that both Phase 3 randomized, double-blind, placebo-controlled studies of oveporexton (TAK-861), namely FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002), have met all primary and secondary endpoints for the treatment of narcolepsy type 1 (NT1).
Oveporexton Mechanism
Oveporexton is a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist. NT1 is caused by the loss of orexin-producing neurons in the brain, and orexin agonists are designed to address this underlying orexin deficiency.
Clinical Trial Results
The FirstLight and RadiantLight studies were two large-scale, global Phase 3 trials conducted across 19 countries. Both studies demonstrated statistically significant improvements compared to placebo, with p-values of <0.001 for all primary and secondary endpoints across all doses at week 12. Key endpoints showed objective and patient-reported improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life, and daily life functions. These improvements reached near-normal ranges across the broad range of symptoms investigated.
Safety Profile
Oveporexton was generally well-tolerated, with a safety profile consistent with previous reports.-Fineline Info & Tech