Danish biopharmaceutical company H. Lundbeck A/S (CPH: HLUN-B), which focuses on brain health, said on Thursday it has received Fast Track designation from the US Food and Drug Administration for Lu AH69593, its lead oral orexin 2 receptor agonist currently in phase 1b development for patients with narcolepsy.

Narcolepsy is a chronic neurological disorder marked by excessive daytime sleepiness, sleep attacks, fragmented night-time sleep, sleep paralysis and hallucinations, with cataplexy also present in type 1 disease. These symptoms can affect daily functioning, education, work, social life and quality of life.

Orexin is a wake-promoting neuropeptide produced in the lateral hypothalamus, signalling through orexin 1 and orexin 2 receptors to regulate arousal, wakefulness and REM sleep. The orexin 2 receptor is considered central to wake-promoting signalling, making it a relevant therapeutic target in disorders characterised by excessive daytime sleepiness.

Lu AH69593 is designed to activate the orexin 2 receptor and enhance wake-promoting signalling, aiming to restore sleep-wake regulation in people with narcolepsy. Lundbeck is assessing its safety, tolerability, pharmacokinetic and pharmacodynamic profile in an ongoing phase 1b programme.

Fast Track designation is intended to facilitate development and expedite review of medicines for serious conditions with unmet medical needs. Lu AH69593 remains investigational and is not approved for marketing.