Alkermes PLC (NASDAQ: ALKS) has recently released positive topline results from a phase 1b study of ALKS 2680, a novel, investigational, oral orexin 2 receptor (OX2R) agonist. The study evaluated the drug's effectiveness in improving wakefulness in patients with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) through once-daily, single, oral administration.
In the NT2 cohort, ALKS 2680 demonstrated improved wakefulness compared to placebo at all doses tested, with a clear dose response. Prior to treatment, patients had baseline sleep latencies ranging from 3 to 33 minutes, with a mean sleep latency of 14 minutes at baseline. Treatment with ALKS 2680 resulted in statistically significant and clinically meaningful improvements in sleep latency, with a mean change from baseline versus placebo of 12 minutes at the 5 mg dose, 19 minutes at the 12 mg dose, and 21 minutes at the 25 mg dose. All treatment-emergent adverse events (TEAEs) were transient and self-resolving, with no serious adverse events or discontinuations reported.
In the IH cohort, treatment with ALKS 2680 also demonstrated improved wakefulness compared to placebo at all doses tested, with a clear dose response. Patients had baseline sleep latencies ranging from 6 to 34 minutes, with a mean sleep latency of 23 minutes at baseline. ALKS 2680 resulted in statistically significant and clinically meaningful improvements in sleep latency, with a mean change from baseline versus placebo of 8 minutes at the 5 mg dose, 11 minutes at the 12 mg dose, and 18 minutes at the 25 mg dose. Similar to the NT2 cohort, all TEAEs were transient and self-resolving, with no serious adverse events or discontinuations reported.
The company plans to initiate a phase 2 study in patients with NT2 in the second half of 2024. Alkermes also expects to submit results from this phase 1b study to a peer-reviewed journal for publication and to present additional ALKS 2680 study results at upcoming scientific meetings.
These results support further clinical evaluation of ALKS 2680 and indicate that orexin 2 receptor agonists such as ALKS 2680 may have utility in treating sleep disorders in patients without known orexin deficiency. Alkermes aims to provide significant clinical benefits for both NT1 and NT2 patient populations with ALKS 2680, and is swiftly moving to select doses for the phase 2 study in NT2.
ALKS 2680 is a significant development in the field of neuroscience, and its potential to transform the current treatment landscape for people living with narcolepsy is a promising prospect. Alkermes PLC, a global biopharmaceutical company, has shown its commitment to developing innovative medicines in the field of neuroscience through the successful results of the ALKS 2680 phase 1b study. Following these announcements, the company's shares moved 2.5%, and are now trading at a price of $26.58. For the full picture, make sure to review Alkermes's 8-K report.
