As mechanism-based orexin agonists get close to market, sleep physicians may feel compelled to reduce ambiguity between narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia diagnoses.
Drug candidates aim to address the root cause of narcolepsy type 1—orexin deficiency—with some also being explored for narcolepsy type 2 and idiopathic hypersomnia.
The company has suspended dosing of patients and has decided to stop both Phase 2 studies early.
The core digital measures of sleep are designed to increase the availability of high-quality sleep assessments in a natural environment and improve research to advance overall population health.
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Takeda announced positive results from a phase 2b trial evaluating TAK-861, an oral orexin receptor 2 agonist, in patients with narcolepsy type 1.
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While DORAs offer a superior safety profile compared to Z-drugs, they fall short in terms of efficacy, leaving an unmet need for additional drug therapies with a superior efficacy and safety profile.
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In a phase 2 trial involving patients with narcolepsy type 1, TAK-994 demonstrated statistically significant improvements in wakefulness and reduced cataplexy rates compared to placebo but was associated with hepatotoxic effects.
Read MoreThe designation was based, in part, on early phase and preliminary clinical data that indicates Takeda’s investigational oral orexin agonist may demonstrate substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients.
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Emmanuel Mignot, MD, PhD, came to the United States to study a colony of narcoleptic dogs at Stanford in the 1980s. Since then, he has grown our knowledge of pharmaceuticals, genetics, and immunological aspects of the sleep disorder.
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