Takeda has reported findings from the Phase II clinical trial of TAK-994 for treating patients with narcolepsy type 1 (NT1).
Dubbed TAK-994-1501, the study evaluated the safety and efficacy of TAK-994, an orexin receptor 2 (OX2R) agonist, for NT1 patients aged 18 to 65 years old.
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In the trial, subjects were administered a twice a day oral dose of either 30mg, 90mg, or 180mg TAK-994 or a placebo.
The variation in minute-based mean sleep latency from baseline to week eight, as per the Maintenance of Wakefulness Test (MWT), was the trial’s primary endpoint.
The variation in weekly cataplexy rate (WCR), Epworth Sleepiness Scale (ESS) score, and treatment-emergent adverse events (TEAEs) comprised the secondary endpoints.
According to the data published in The New England Journal of Medicine, TAK-994 was found to offer a statistically significant rise in daytime wakefulness.
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By GlobalDataRegarding the primary endpoint, changes in mean sleep latency on the MWT to week eight were found to be 23.9, 27.4, 32.6, and -2.5 minutes for the three doses and the placebo, respectively.
The WCR was reduced or eliminated at all test dosages compared to the placebo.
Adverse events were reported in 79% of the trial subjects, with urinary urgency or frequency being the most common one.
Due to hepatotoxicity observed in several subjects, this study was halted. Takeda noted that the agent will not be advanced for treating narcolepsy.
The company also noted that the latest data demonstrated that OX2R could be a potential new biologic target for NT1 therapies.
Takeda Neuroscience Therapeutic Area Unit head Sarah Sheikh said: “As leaders in orexin research and development, Takeda is committed to applying our learnings from the TAK-994 trial and our deep and growing understanding of orexin biology as we drive forward the research and development of multiple orexin assets.
“Takeda is also exploring other indications that could benefit from this mechanism.”
In June 2023, the company reported interim data from a Phase III trial of TAK-755 for congenital thrombotic thrombocytopenic purpura.
