Of 73 patients enrolled, 17 received TAK-994 30 mg twice daily, 20 received 90 mg twice daily, 19 received 180 mg twice daily, and 17 received placebo. Another Takeda oral OX2R agonist is being evaluated in two Phase 2, randomized, double-blind, placebo-controlled trials for the treatment of narcolepsy. The trial was prematurely terminated due to hepatotoxicity in several patients and this agent will not go forward as a treatment for narcolepsy but may indicate a biologic target for future development. Limitations of the trial are that it was terminated early, the number of participants was small, and there was substantial dropout and missing data. Patients completing the Phase 2 treatment period were eligible for inclusion in an extension trial. However, TAK-994 was associated with hepatotoxicity, therefore studies with new well tolerated OX2R agonists are strongly requested." "Although this study was not designed to compare TAK-994, the first-in-class oral OX2R agonist, with other narcolepsy drugs, its effectiveness on objective measures of wakefulness, self-reported assessment of daytime sleepiness, and frequency of cataplexy was impressive. Moreover, none of the available agents target the underlying cause of the disease," said one of the TAK-994 study principal investigators Yves Dauvilliers, M.D., Director, Sleep-Wake Disorders Center, Department of Neurology, Gui de Chauliac Hospital, Montpellier, France. Today, most patients with NT1 require multiple therapies that only manage excessive daytime sleepiness and cataplexy. "There is significant unmet need for patients with narcolepsy, a chronic neurologic disease caused by severe loss or absence of the neuropeptide orexin, also known as hypocretin. The article appears in the July 27 issue of the journal and is titled, "Oral Orexin Receptor 2 Agonist in Narcolepsy Type 1." These data represent the first-ever clinical data to be published of an oral orexin agonist in NT1. OSAKA, Japan & CAMBRIDGE, Mass., July 26, 2023-( BUSINESS WIRE)-Takeda ( TSE:4502/NYSE:TAK ) today announced that data from the Phase 2 study of orexin receptor 2 (OX2R) agonist TAK-994 in patients with narcolepsy type 1 (NT1) was published in The New England Journal of Medicine. Takeda Continues to Advance a Multi-Asset Orexin Agonist Franchise In Patients with Narcolepsy Type 1, Oral Orexin Receptor 2 Agonist Demonstrated Statistically Significant Improvement in Daytime Wakefulness Weekly Cataplexy Rates Reduced or Abolished at All Doses Compared to Placeboįindings Indicate Orexin Receptor 2 as Promising Novel Biologic Target for Future Development of Narcolepsy Type 1 Treatments Trial Was Stopped Due to Hepatotoxicity and Consequently TAK-994 Program Terminated for Further Development
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