Alkermes' (ALKS) ALKS 2680 Betters Wakefulness in Phase Ib Study

Core Insights - Alkermes plc announced positive top-line data from a phase Ib study for its oral orexin 2 receptor agonist, ALKS 2680, aimed at treating narcolepsy [1] - The study showed statistically significant improvements in mean sleep latency on the Maintenance of Wakefulness Test across all tested doses [1][2] - Alkermes plans to initiate a phase II study for ALKS 2680 in narcolepsy type 2 (NT2) in the second half of 2024 [2] Study Details - The phase Ib study evaluated ALKS 2680 in narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) cohorts, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics [1] - Doses tested in the study included 5 mg, 12 mg, and 25 mg, all showing clinically meaningful results [1][2] Market Context - If approved, ALKS 2680 could significantly change the treatment landscape for narcolepsy, although it may face competition from Axsome's Sunosi [2] - Axsome acquired U.S. rights to Sunosi in May 2022 and began marketing it shortly thereafter, with prior approval received in 2019 [3] - Jazz Pharmaceuticals also has a strong market presence with other sleep disorder drugs, Xyrem and Xywav [3]