Alkermes(US:ALKS) Prnewswireยท2025-09-08 07:15Core Insights - Alkermes plc announced positive results from the Vibrance-1 phase 2 study of alixorexton, a novel orexin 2 receptor agonist for narcolepsy type 1, demonstrating significant improvements in wakefulness, cognition, and fatigue with once-daily dosing [1][2][4] Study Results - The Vibrance-1 study involved 92 patients and showed statistically significant improvements in mean sleep latency on the Maintenance of Wakefulness Test (MWT) at week six, with mean sleep latencies of approximately 24, 26, and 28 minutes for the 4 mg, 6 mg, and 8 mg doses respectively, compared to a baseline of about 3 minutes [4][5] - Alixorexton also achieved significant improvements in the Epworth Sleepiness Scale (ESS) scores, with baseline scores of 18.5 and reductions to the normal range (a score of 10) across all doses [4][5] - More than 40% of patients on the 6 mg and 8 mg doses experienced a 100% reduction in cataplexy during week six [4][5] Safety Profile - Alixorexton was generally well tolerated across all tested doses, with no serious treatment-emergent adverse events reported [6][4] - The most common mild to moderate adverse events included pollakiuria, insomnia, and blurred vision, with most events resolving within the first week of treatment [6][4] Future Plans - Alkermes plans to initiate a global phase 3 program for alixorexton in the first quarter of 2026, following the positive phase 2 results [8][4] - The company is also advancing other orexin-targeted therapeutics into first-in-human studies this year [8]