Alkermes presents data from phase 1b study of ALKS 2680

Alkermes announced new data from the full narcolepsy type 1 cohort of a phase 1b, proof-of-concept study evaluating ALKS 2680, the company’s novel, investigational, oral orexin 2 receptor agonist in development as a once-daily treatment for narcolepsy. The data are being presented at SLEEP 2024, the 38th annual meeting of the Associated Professional Sleep Societies, taking place June 1-5, 2024 in Houston. Mean Sleep Latency Over 8 Hours: In patients with NT1, treatment with ALKS 2680 demonstrated improved wakefulness compared to placebo at all doses tested, with a clear dose response. Treatment with ALKS 2680 resulted in statistically significant and clinically meaningful improvements in mean sleep latency on the Maintenance of Wakefulness Test, with a mean change from baseline versus placebo of 18.4 minutes at the 1 mg dose, 22.6 minutes at the 3 mg dose, and 34.0 minutes at the 8 mg dose. At the 3 mg and 8 mg doses, the observed mean MWT scores over an eight-hour period post-dose were within the reported normal range for healthy individuals. Patient-Reported Alertness on the Karolinska Sleepiness Scale: The KSS is a subjective measure of self-reported alertness over the past five minutes, using a nine-point scale. Change from baseline on KSS was an exploratory endpoint. ALKS 2680 demonstrated clinically meaningful, dose-dependent improvements in self-reported alertness in patients with NT1. The average self-reported score at baseline was approximately 7. ALKS 2680 showed improvements of 2 to 3 points in self-reported alertness between 1 and 8 hours. Safety: ALKS 2680 was generally well tolerated across all doses tested in patients with NT1. Most treatment-emergent adverse events were mild in severity, transient and self-resolving. There were no serious AEs reported or TEAEs leading to study drug discontinuation in patients with NT1.