DUBLIN, Ireland I April 24, 2024 I Alkermes plc (Nasdaq: ALKS) today announced initiation of the Vibrance-1 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 compared to placebo in patients with narcolepsy type 1 (NT1). ALKS 2680 is the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy, a chronic, neurological disorder characterized by excessive daytime sleepiness. NT1 is associated with an absence or significant deficiency in orexin levels, and the presence of cataplexy, a sudden loss of muscle tone triggered by strong emotions.

“ALKS 2680 offers the potential to harness the orexin system, the master regulator of wakefulness, by addressing the loss of orexin signaling common in people with narcolepsy type 1. Based on data from our phase 1, proof-of-concept study, we are excited to advance this novel oral compound to phase 2,” said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. “Initiation of the Vibrance-1 study is a significant milestone for the ALKS 2680 development program, and we look forward to further characterizing ALKS 2680’s safety and efficacy profile throughout this phase 2 study.”

Vibrance-1 is a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of ALKS 2680 in people with NT1. Participants will be randomized to receive one of three doses of ALKS 2680 (4 mg, 6 mg or 8 mg) or placebo to be taken once-daily for six 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, mean weekly cataplexy rate (WCR) and incidence of adverse events. The study is expected to enroll approximately 80 patients with NT1 across sites in the U.S., Australia and Europe. All participants in the double-blind portion of the study will be eligible to continue in the open-label safety extension portion of the study.

More information can be found at www.clinicaltrials.gov (identifier: NCT06358950) and www.vibrancestudies.com (for U.S. audiences only).

The company expects to initiate Vibrance-2, a planned phase 2 study in patients with narcolepsy type 2, in the second half of 2024.

About ALKS 2680

ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy. Orexin neuropeptides are important regulators of the sleep/wake cycle through OX2R activation, and loss of orexinergic neurons in the brain is associated with excessive daytime sleepiness and cataplexy in narcolepsy.1 ALKS 2680 was designed to address the underlying pathology of narcolepsy with the goal of improving duration of wakefulness and providing cataplexy control. Once-daily oral administration of ALKS 2680 was previously evaluated in a phase 1 study in healthy volunteers and people living with narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia.

About Alkermes plc

Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com

SOURCE: Alkermes