Takeda reports progress in narcolepsy type 1 treatment

OSAKA, Japan & CAMBRIDGE, Mass. - Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE:TAK) has shared results from its Phase 2b clinical trial for oveporexton (TAK-861), a drug being tested for the treatment of narcolepsy type 1 (NT1). The data, published in the New England Journal of Medicine, indicates that oveporexton significantly improved wakefulness and reduced symptoms compared to a placebo.

NT1, a chronic neurological condition, leads to excessive daytime sleepiness, sudden loss of muscle tone, cognitive issues, and other symptoms that can significantly impact quality of life. Oveporexton, an orexin receptor 2 agonist, aims to restore orexin signaling, which is deficient in NT1 patients.

The trial enrolled 112 adults globally, who were randomized to receive either the drug or a placebo over eight weeks. Results showed improvements in mean sleep latency on the Maintenance of Wakefulness Test, a key measure of wakefulness, and reductions in Epworth Sleepiness Scale scores and Weekly Cataplexy Rate. Exploratory endpoints also indicated improvements in disease severity and quality of life. With annual revenues of $30.5 billion and analyst targets suggesting potential upside, Takeda appears well-positioned to advance this promising treatment.

Most treatment-emergent adverse events reported were mild to moderate and included insomnia, increased urinary urgency, and frequency. The majority of participants continued into a long-term extension study, with many reaching one year or more of treatment.

Oveporexton has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness in NT1. Takeda anticipates Phase 3 trial results in 2025, with hopes that oveporexton will become a first-in-class treatment option. Based on InvestingPro’s Fair Value analysis, Takeda’s stock currently appears undervalued, with additional ProTips available for subscribers looking to dive deeper into the company’s investment potential.

Takeda is also advancing other orexin agonists for various sleep-wake disorders as part of its broader commitment to addressing unmet medical needs. This press release statement provides a glimpse into the ongoing efforts by Takeda to innovate in the field of sleep medicine.

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