Alkermes Launches Phase 2 Trial of ALKS 2680 for Narcolepsy Type 1 Treatment

Alkermes plc, a leading biopharmaceutical firm, has recently launched the Vibrance-1 phase 2 clinical trial to assess the safety and effectiveness of ALKS 2680. This oral medication is a novel orexin 2 receptor (OX2R) agonist, developed to treat narcolepsy type 1 (NT1), a chronic neurological condition marked by excessive daytime sleepiness and cataplexy, a sudden loss of muscle tone triggered by strong emotions.

The medication is designed to exploit the orexin system, which is a key regulator of wakefulness, and aims to counteract the deficiency in orexin signaling common among NT1 patients. Craig Hopkinson, Alkermes' Chief Medical Officer and Executive Vice President of Research & Development, expressed enthusiasm for the advancement of ALKS 2680 into phase 2, following positive results from a phase 1 proof-of-concept study.

The Vibrance-1 trial is a randomized, double-blind, placebo-controlled study that will evaluate the medication's safety and efficacy in approximately 80 NT1 patients. Participants will be assigned to receive either one of three dosages of ALKS 2680 (4 mg, 6 mg, or 8 mg) or a placebo once daily for six weeks. The primary goal of the trial is to determine if there is a significant reduction in sleepiness among those taking ALKS 2680, as measured by the maintenance of wakefulness test (MWT). Secondary objectives include assessing changes in the Epworth Sleepiness Scale (ESS) score, the mean weekly cataplexy rate (WCR), and the occurrence of adverse events.

Alkermes has also indicated plans to initiate the Vibrance-2 study, another phase 2 trial focused on narcolepsy type 2 patients, in the latter half of 2024. ALKS 2680 is an investigational medication intended for once-daily oral administration and has been previously evaluated in a phase 1 study involving healthy volunteers and individuals with various sleep disorders.

Alkermes plc, headquartered in Dublin, Ireland, is dedicated to developing innovative treatments in neuroscience. The company's product portfolio includes proprietary commercial products for treating alcohol and opioid dependence, schizophrenia, and bipolar I disorder. Additionally, Alkermes has a robust pipeline of clinical and preclinical candidates for neurological disorders. The company operates a research and development center in Waltham, Massachusetts, a research and manufacturing facility in Athlone, Ireland, and a manufacturing facility in Wilmington, Ohio.

For those seeking more information on the clinical trial, details can be found at www.clinicaltrials.gov with the identifier NCT06358950, and for U.S. audiences, www.vibrancestudies.com provides further insights.