Alkermes today announced initiation of the Vibrance-2 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with narcolepsy type 2 (NT2). ALKS 2680 is the company’s novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy, a chronic, neurological disorder characterized by excessive daytime sleepiness.
“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 phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of ALKS 2680 in adults with NT2. 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 whether participants taking ALKS 2680 experience a greater decrease in sleepiness compared to participants taking placebo alone, as measured by the change in mean sleep latency on the maintenance of wakefulness test (MWT). Secondary endpoints include change in Epworth Sleepiness Scale (ESS) score and incidence of adverse events. The study is expected to enroll approximately 80 patients with NT2 across sites in the U.S., Australia and Europe. All participants who complete the double-blind portion of the study will be eligible to continue in the open-label safety extension.
Vibrance-1, a phase 2 study evaluating the efficacy and safety of ALKS 2680 in adults with narcolepsy type 1, is currently enrolling.
