Alkermes Announces Initiation of Vibrance-3 Phase 2 Study Evaluating ALKS 2680 for the Treatment of Idiopathic Hypersomnia

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[{"type":"text","content":"DUBLIN, April 1, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the initiation of Vibrance-3, a phase 2 clinical study evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with idiopathic hypersomnia (IH). ALKS 2680 is the company's novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy type 1, narcolepsy type 2 and IH – chronic, neurological disorders characterized by excessive daytime sleepiness.\n\"The initiation of Vibrance-3 represents an important step forward for the ALKS 2680 development program as we seek to advance a potential new treatment option for people living with idiopathic hypersomnia. There remains high unmet need for the idiopathic hypersomnia community, as evidenced by a recent survey conducted by the Sleep Consortium1 in which more than 90% of patients surveyed indicated that IH symptoms had a moderate to high impact on their life,\" said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. \"The Vibrance-3 phase 2 study builds on encouraging data from our phase 1b, proof-of-concept study of ALKS 2680 in patients with IH, and we look forward to further characterizing its safety and efficacy profile in this patient population.\"\nVibrance-3 is a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of ALKS 2680 in adults with IH. Participants will be randomized to receive one of three doses of ALKS 2680 (10 mg, 14 mg or 18 mg) or placebo to be taken once-daily for eight weeks. The primary endpoint will assess, by dose level, whether participants taking ALKS 2680 experience a greater decrease in sleepiness compared to participants taking placebo alone, as measured by the change in Epworth Sleepiness Scale (ESS) score. Secondary endpoints include change in Idiopathic Hypersomnia Severity Scale (IHSS) score and incidence of adverse events. The study is expected to enroll approximately 96 patients with IH across sites in the U.S., Australia and Europe. Participants who complete the study will be eligible to continue in a long-term, open-label, safety study (NCT06767683).\nMore information can be found at www.clinicaltrials.gov (identifier: NCT06843590) and www.vibrancestudies.com ...

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