Centessa announces interim data from ongoing Phase 1 trial of ORX750

Centessa Pharmaceuticals announced positive interim data from an ongoing Phase 1 trial of its highly potent and selective orexin receptor 2 agonist, ORX750, in acutely sleep-deprived healthy volunteers. ORX750 showed clinically meaningful and statistically significant improvements in mean sleep latency at the first two doses evaluated in the Maintenance of Wakefulness Test, MWT, compared to placebo. More specifically, the 2.5 mg dose was shown to restore normative wakefulness2 with a mean sleep latency of 32 minutes as measured by the MWT. ORX750 was also shown to have a favorable safety and tolerability profile with no observations of frequently reported on-target adverse events, AEs, associated with other OX2R agonists, and no cases of hepatotoxicity or visual disturbances across all three dose levels tested, as of the data cutoff date.1 Based on the interim data, the Company plans to rapidly advance ORX750 into Phase 2 studies in patients with narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia beginning in the fourth quarter of 2024.