Alkermes Commences Vibrance-2 phase 2 study of ALKS 2680

Alkermes plc has commenced the Vibrance-2 study, which is a phase 2 clinical trial assessing the safety and effectiveness of ALKS 2680 versus placebo in adult patients with narcolepsy type 2 (NT2). ALKS 2680 is a new, under investigation, oral medication that targets the selective orexin 2 receptor (OX2R) and is being developed as a daily therapy for narcolepsy, a chronic neurological condition known for causing too much sleepiness during the day.

"We are pleased to initiate Vibrance-2, a phase 2 clinical study for adults with narcolepsy type 2, based on the data from our phase 1, proof-of-concept study in this patient population. ALKS 2680 is the most advanced investigational orexin 2 receptor agonist currently in development for narcolepsy type 2," said Craig Hopkinson, M.D., chief medical officer and executive vice president, research & development at Alkermes. "Across narcolepsy type 1 and narcolepsy type 2, significant unmet need remains, and we look forward to further characterizing the efficacy and safety profile of ALKS 2680 in the Vibrance studies in both of these important patient populations."

Vibrance-2 is a clinical trial in phase 2 that is random, double-blind, and aims to find the correct dosage range of ALKS 2680, assessing its safety and effectiveness in adults with NT2. Subjects will be assigned at random to get either one of three amounts of ALKS 2680 (10 mg, 14 mg, or 18 mg) or a placebo to be taken once per day for a period of eight weeks. The main goal is to determine if participants who take ALKS 2680 show a larger reduction in sleepiness compared to those taking placebo, based on the change in average sleep latency on the MWT.