FDA clears IND for Centessa's ORX750 Phase 1 trial in narcolepsy; PoC data expected 2H 2024

Centessa Pharmaceuticals plc

FDA cleared IND for ORX750, an oral OX2R agonist targeting narcolepsy type 1 (NT1), NT2, and idiopathic hypersomnia.
Phase 1 study includes SAD, MAD, and cross-over PoC using Maintenance of Wakefulness Test and Karolinska Sleepiness Scale in sleep-deprived healthy volunteers.
FDA-set maximum exposure limit significantly exceeds predicted efficacious doses; no impact on planned development.
Dosing to begin imminently; proof-of-concept data anticipated in second half of 2024.

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