The P-IIb clinical trial evaluates the effects of TAK-861 (oral OX2R agonist) vs PBO narcolepsy symptoms incl. EDS & number of cataplexy episodes in patients (n=112) with Narcolepsy Type 1 (NT1). Takeda is also evaluating TAK-861 in P-IIb studies among NT2 patients
The study met its 1EPs of MWT & 2EPs of ESS & WCR by depicting a statistically significant & clinically meaningful improvement in objective & subjective measures of wakefulness at wk8
Additionally, based on these results & consultation with global health authorities, Takeda expects to initiate a P-III trial for TAK-861 in NT1 patients by H1’24 and does not plan to advance TAK-861 in NT2
Ref: Takeda | Image: Takeda
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