Takeda will showcase data from its Phase 2b trials and long-term extension study of TAK-861, an investigational orexin receptor 2 agonist, for narcolepsy type 1 (NT1) at Sleep Europe 2024.
TAK-861 aims to address the orexin deficiency in NT1 by stimulating the orexin receptor 2. Promising Phase 2b results have led to initiating the FirstLight Study, a global Phase 3 trial assessing TAK-861’s efficacy and safety in adults with NT1.
Data from the Phase 2b trials will highlight TAK-861’s impact on cognitive impairment, nocturnal sleep quality, and sustained attention in NT1 patients. Additionally, interim safety and efficacy results from the ongoing long-term extension study will be presented.
Elena Koundourakis of Takeda emphasizes that NT1 patients experience debilitating symptoms beyond excessive daytime sleepiness, and Takeda is committed to advancing orexin research.
These data presentations contribute to the growing understanding of orexin agonists in treating NT1. Takeda continues to develop targeted therapies for individuals with sleep-wake disorders, including NT2 and idiopathic hypersomnia.
More information about the FirstLight Study, actively recruiting participants, is available at clinicaltrials.gov (NCT06470828) and firstlightstudy.com (for US audiences). Takeda currently has no approved therapies for narcolepsy.
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.