Narcolepsy is a chronic, rare neurological disorder of central hypersomnolence (excessive daytime sleepiness) classified into two different types: 

• Narcolepsy type 1 (NT1) is caused by a significant loss of orexin neurons with a resulting lack of orexin.
• Narcolepsy type 2 (NT2), where orexin levels are generally normal. 

Two separate Phase 2b studies were conducted in NT1 and NT2.

The NT1 trial TAK-861-2001 evaluating TAK-861 in 112 patients demonstrated a statistically significant and clinically meaningful improvement in objective and subjective measures of wakefulness compared to placebo at week 8, including on the primary endpoint Maintenance of Wakefulness Test (p < 0.001). 

Improvements in key secondary endpoints, including the Epworth Sleepiness Scale and Weekly Cataplexy Rate, were statistically significant and clinically meaningful, consistent with the primary endpoint. 

Takeda plans to initiate global Phase 3 trials of TAK-861 in NT1 in the first half of its fiscal year 2024.

At this time, Takeda does not plan to advance TAK-861 in NT2. Data are being further analyzed to determine the next steps in orexin normal populations.

TAK-861 was generally safe and well tolerated in both trials. No treatment-related serious adverse events were reported.

Last week, Takeda Pharmaceutical reported a third-quarter 2023 core net profit of ¥235.9 billion, down 9.4% and 9.5% on constant currency.

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Price Action: TAK shares are up 1.29% at $14.18 on the last check Friday.

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