Centessa advances narcolepsy drug to Phase 2 after no adverse effects seen

Centessa Pharmaceuticals is advancing its orexin receptor 2 agonist, ORX750, into mid-stage clinical trials for narcolepsy following promising results from a Phase 1 study. The trial, conducted on sleep-deprived healthy volunteers, demonstrated that ORX750 effectively helped participants remain awake. Crucially, the company reported no frequent on-target adverse effects, which are commonly associated with this class of drugs.

The company intends to initiate Phase 2 trials in the fourth quarter of this year. These trials will include patients with narcolepsy type 1 and type 2, as well as those suffering from idiopathic hypersomnia, a condition characterized by excessive sleep and daytime drowsiness.

Drugs in this class have previously been linked to side effects such as visual disturbances and liver toxicity. Indeed, these liver-related issues led to the discontinuation of Takeda's orexin receptor agonist, TAK-994, back in 2021. However, earlier this year, Takeda shared positive efficacy data for a related molecule, TAK-861, and expressed plans to advance it to Phase 3 trials expeditiously. Besides Takeda, Alkermes is another company with a similar drug currently in Phase 2 testing.

This progress by Centessa Pharmaceuticals represents a significant step forward in the treatment of sleep disorders like narcolepsy and idiopathic hypersomnia, offering hope to patients who struggle with excessive sleepiness and disrupted sleep cycles. As the company moves forward with its clinical trials, the medical community and patients alike will be watching closely for further developments and potential breakthroughs in this field.

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