Centessa Pharmaceuticals announced that the U.S. FDA has cleared its investigational new drug (IND) application for ORX142, a novel orexin receptor 2 agonist in development for sleep-wake disorders and select neurological and neurodegenerative conditions.
About ORX142
ORX142 is an investigational, novel, highly potent and selective orexin receptor 2 agonist. With the IND now cleared, Centessa plans to initiate a Phase 1 clinical trial this year in acutely sleep-deprived healthy volunteers.
The study will evaluate safety, tolerability and pharmacokinetics following both single-ascending and multiple-ascending doses in healthy volunteers. In parallel, a placebo-controlled crossover pharmacodynamic assessment will be conducted using the Maintenance of Wakefulness Test and the Karolinska Sleepiness Scale to assess wake-promoting effects.
According to the company, the trial is designed to provide early proof-of-concept data and inform dose selection for future clinical studies.
ORX142 is part of Centessa’s broader orexin agonist portfolio. The company is also developing ORX750, which is being evaluated in a Phase 2a study for narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia.
Both ORX142 and ORX750 are investigational candidates and have not been approved by the FDA. Read more industry news from the AASM.
Read more industry news from the AASM.
