Poster
122
(#122) Efficacy and Safety of TAK-861, an Oral Orexin Receptor 2 Agonist, in Individuals With Narcolepsy Type 1: Results From a Phase 2 Trial and Long-Term Extension Study Interim Analysis
Psych Congress 2025
Abstract: Narcolepsy type 1 (NT1) is characterized by excessive daytime sleepiness and cataplexy, and associated with low cerebrospinal fluid orexin levels. The orexin receptor 2-selective agonist TAK-861 has wake-promoting effects and improves cataplexy-like symptoms in animal models of narcolepsy.
We evaluated efficacy and safety of TAK-861 in patients with NT1 enrolled in a phase 2 (ph2) trial (NCT05687903) and its ongoing long-term extension (LTE) study (NCT05816382). This completed 8-week randomized trial assessed change from baseline to week 8 in mean sleep onset latency with the Maintenance of Wakefulness Test (SOL-MWT; primary endpoint), Epworth Sleepiness Scale (ESS) total score, weekly cataplexy rate (WCR), and occurrence of treatment-emergent adverse events (TEAEs). LTE endpoints included occurrence of TEAEs (primary) and change in SOL-MWT, total ESS score, and WCR (secondary).
Of 112 participants randomized to TAK-861 or placebo, 104 continued into the LTE. Compared with placebo, improvements from baseline to week 8 were achieved with TAK-861 doses in SOL-MWT (LS mean change 12.5-25.4 vs -1.2 minutes; all P≤0.001), ESS total score (all P 0.01), and WCR (2mg BID and 2mg/5mg; P 0.05). Improvements were maintained in the LTE (interim analysis). TEAEs occurred in 77.8% of participants with TAK-861 in the ph2 trial and 54.8% in LTE. Most common TEAEs were urinary urgency/frequency and insomnia. There were no treatment-related serious TEAEs.
In this ph2 trial and LTE interim analysis, participants with NT1 taking TAK-861 showed significant improvements in SOL-MWT, ESS, and WCR vs placebo, which were maintained up to at least 6 months. TAK-861 was well tolerated.
Short Description: We evaluated the efficacy and safety of TAK-861 in patients with narcolepsy type 1 enrolled in a phase 2 trial (NCT05687903) and its ongoing long-term extension (LTE) study (NCT05816382). TAK-861 was well tolerated, and improvements in SOL-MWT, ESS, and WCR that were found in patients in the TAK-861 group vs placebo during the main study were maintained in the interim analysis of the LTE.
Name of Sponsoring Organization(s): Takeda Development Center Americas, Inc.
We evaluated efficacy and safety of TAK-861 in patients with NT1 enrolled in a phase 2 (ph2) trial (NCT05687903) and its ongoing long-term extension (LTE) study (NCT05816382). This completed 8-week randomized trial assessed change from baseline to week 8 in mean sleep onset latency with the Maintenance of Wakefulness Test (SOL-MWT; primary endpoint), Epworth Sleepiness Scale (ESS) total score, weekly cataplexy rate (WCR), and occurrence of treatment-emergent adverse events (TEAEs). LTE endpoints included occurrence of TEAEs (primary) and change in SOL-MWT, total ESS score, and WCR (secondary).
Of 112 participants randomized to TAK-861 or placebo, 104 continued into the LTE. Compared with placebo, improvements from baseline to week 8 were achieved with TAK-861 doses in SOL-MWT (LS mean change 12.5-25.4 vs -1.2 minutes; all P≤0.001), ESS total score (all P 0.01), and WCR (2mg BID and 2mg/5mg; P 0.05). Improvements were maintained in the LTE (interim analysis). TEAEs occurred in 77.8% of participants with TAK-861 in the ph2 trial and 54.8% in LTE. Most common TEAEs were urinary urgency/frequency and insomnia. There were no treatment-related serious TEAEs.
In this ph2 trial and LTE interim analysis, participants with NT1 taking TAK-861 showed significant improvements in SOL-MWT, ESS, and WCR vs placebo, which were maintained up to at least 6 months. TAK-861 was well tolerated.
Short Description: We evaluated the efficacy and safety of TAK-861 in patients with narcolepsy type 1 enrolled in a phase 2 trial (NCT05687903) and its ongoing long-term extension (LTE) study (NCT05816382). TAK-861 was well tolerated, and improvements in SOL-MWT, ESS, and WCR that were found in patients in the TAK-861 group vs placebo during the main study were maintained in the interim analysis of the LTE.
Name of Sponsoring Organization(s): Takeda Development Center Americas, Inc.
