A Phase 2b trial has demonstrated significant improvements for TAK-861, an investigational treatment for narcolepsy type 1 (NT1). The trial involved 112 patients and evaluated the efficacy and safety of TAK-861 over 8 weeks.
NT1 is a chronic neurological disorder caused by the loss of orexin neurons. This results in low levels of orexin neuropeptides, leading to excessive daytime sleepiness, cataplexy, and other debilitating symptoms.
TAK-861 is an orexin receptor 2 agonist that aims to address the underlying orexin deficiency in NT1. The trial results showed statistically significant improvements in primary and secondary endpoints, including:
• Excessive daytime sleepiness
• Cataplexy frequency
• Nighttime sleep quality
• Hallucinations and sleep paralysis
The results also indicated that TAK-861 was generally safe and well-tolerated. Based on these findings, the researchers concluded that TAK-861 has the potential to be a transformative treatment for NT1, potentially providing substantial improvements over available therapies.
Takeda plans to initiate global Phase 3 trials of TAK-861 in NT1 in the first half of 2024. The Phase 2b data also supported the recent Breakthrough Therapy designation for TAK-861 from the U.S. Food and Drug Administration (FDA). This designation accelerates the development and review process for drugs that address serious or life-threatening conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
