Takeda to rapidly progress first Phase III TAK-861 trials in narcolepsy type 1

Japan’s largest drugmaker Takeda Pharma (TYO: 4502) has announced positive top-line 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.

Takeda explained that narcolepsy is a chronic, rare neurological disorder of central hypersomnolence with significant unmet need despite multiple approved therapies. It is currently classified into two different types: narcolepsy type 1 (NT1) caused by significant loss of orexin neurons with resulting lack of orexin, and narcolepsy type 2 (NT2) where orexin levels are generally normal. Stimulating the orexin receptor 2 in NT1 patients targets the underlying pathophysiology of the disease to restore orexin signaling. Two separate Phase IIb studies were conducted in NT1 and NT2.

Key study findings