Alkermes plc ALKS announced positive top-line data from a phase Ib study evaluating its novel, investigational, oral orexin 2 receptor (OX2R) agonist, ALKS 2680, as a once-daily treatment for narcolepsy.

The above data was from the narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) cohorts of the early-stage proof-of-concept study, which evaluated ALKS 2680 for the given indication.

The phase Ib NT2 and IH study cohorts investigated the safety, tolerability, pharmacokinetics and pharmacodynamics of various doses of ALKS 2680 (5 mg, 12 mg and 25 mg).

Data from the study showed that treatment with ALKS 2680 led to clinically meaningful and statistically significant improvements in mean sleep latency on the Maintenance of Wakefulness Test (MWT) versus placebo from baseline at all doses tested.

Additionally, treatment with ALKS 2680 was generally well tolerated in both patient populations.

Building upon the success of the above mentioned phase Ib proof-of-concept study, Alkermes is looking to select doses for a phase II study on ALKS 2680 in NT2. The company plans to initiate a phase II study evaluating ALKS 2680 in patients with NT2 during the second half of 2024.

In January 2024, Alkermes completed the narcolepsy type 1 cohort in the phase Ib study evaluating ALKS 2680 for the treatment of narcolepsy.

Per the company, if successfully developed and upon potential approval, ALKS 2680 might have the potential to transform the current treatment landscape for narcolepsy.

However, upon potential approval, ALKS 2680 is likely to face some competition from Axsome’s AXSM Sunosi (solriamfetol), which is presently marketed in the United States for the treatment of narcolepsy.

Axsome acquired the U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ in May 2022. AXSM began selling Sunosi in the U.S. market in May 2022.

Jazz received approval for Sunosi as a treatment for narcolepsy in 2019.

In February 2023, Axsome entered into a licensing agreement with Pharmanovia to market Sunosi in Europe and some other countries.

Jazz’s other sleep disorder drugs, Xyrem and Xywav, also hold a strong market share.

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