Alkermes (ALKS) Status Update summary

Program overview and clinical progress

• ALKS-2680, a potent and selective orexin-2 receptor agonist, is advancing through phase 2 trials for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH), with once-daily dosing designed to mimic natural sleep-wake cycles.

• Phase 1b data demonstrated statistically significant and clinically meaningful improvements in wakefulness and sleep latency across all three indications, with a favorable safety and tolerability profile.

• Phase 2 studies (Vibrance-1 for NT1 and Vibrance-2 for NT2) are enrolling in Australia, the US, and planned for Europe, featuring dose flexibility and open-label extensions; a phase 2 study in IH (Vibrance-3) is planned.

• Dose selection and trial design are informed by robust preclinical and translational modeling, integrating pharmacokinetics, pharmacodynamics, and patient-specific data.

• The program is structured to support rapid progression to phase 3, with data readouts expected in the second half of next year.

Study design and objectives

• Phase 1b randomized, double-blind, placebo-controlled study evaluated ALKS 2680 in patients with NT2, assessing safety, tolerability, and changes in sleep latency using the Maintenance of Wakefulness Test (MWT).

• Study design enabled precise dose selection for future phase 2 trials.

Patient characteristics

• Participants had moderate to severe NT2, with a mean age of 36 and significant baseline sleepiness; baseline MWT mean was 14.3 minutes.