Centessa reports positive phase 1 clinical data for ORX750

Promising results for novel orexin agonist in sleep-deprived volunteers

Nxera Pharma, formerly known as Sosei Group, has announced that its partner, Centessa Pharmaceuticals, has reported encouraging interim results from a Phase 1 clinical trial of ORX750.

The novel orexin receptor 2 (OX2R) agonist was tested in acutely sleep-deprived healthy volunteers.

The trial revealed that ORX750 significantly improved mean sleep latency at doses of 1.0 mg and 2.5 mg, as measured by the Maintenance of Wakefulness Test (MWT), compared to a placebo. Notably, the 2.5 mg dose restored normative wakefulness with a mean sleep latency of 32 minutes.

Safety and tolerability were also strong points for ORX750, with no frequently reported adverse events typically associated with other OX2R agonists. Additionally, there were no cases of hepatotoxicity or visual disturbances across all tested doses (1.0 mg, 2.0 mg, and 2.5 mg).

Given these promising results, Centessa plans to advance ORX750 into Phase 2 studies targeting patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) starting in the fourth quarter of 2024.

Nxera will update stakeholders on any milestone events that trigger material payments from Centessa.

This development represents a significant advancement in the treatment of sleep-wake disorders, potentially improving the quality of life for those affected by narcolepsy and related conditions.