Centessa Pharmaceuticals Receives FDA Clearance for New Drug ORX142, Initiates Phase 1 Study

Centessa Pharmaceuticals (NASDAQ:CNTA) is one of the best biotech stocks to invest in now. On June 16, Centessa Pharmaceuticals announced that the US FDA cleared its Investigational New Drug/IND application for ORX142. The clearance allows Centessa to initiate a Phase 1 clinical study of ORX142 in healthy volunteers.

ORX142 is a novel, highly potent, and selective orexin receptor 2 (OX2R) agonist, and it represents the second drug candidate from the company’s multi-asset orexin franchise. The company’s most advanced OX2R agonist, ORX750, is currently in the Phase 2a CRYSTAL-1 study for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH). With ORX142, Centessa aims to explore its potential for several neurological and neurodegenerative disorders that have unmet needs.

Centessa Pharmaceuticals Receives FDA Clearance for New Drug ORX142, Initiates Phase 1 Study

Lab technicians in safety glasses and lab coats conducting a clinical trial of a new pharmaceutical.

The Phase 1 study for ORX142 will evaluate its safety, tolerability, and pharmacokinetics. Centessa plans to begin the first-in-human clinical study imminently, with early proof-of-concept data expected in 2025. This data will help in selecting the appropriate dose for future studies involving patients. Orexin is a neuropeptide for regulating the sleep-wake cycle. Targeting the orexin pathway with OX2R agonists is a promising strategy to address issues like excessive daytime sleepiness/EDS, impaired attention, cognitive deficits, and fatigue.

Centessa Pharmaceuticals (NASDAQ:CNTA) is a clinical-stage pharmaceutical company that discovers, develops, and delivers medicines.

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Disclosure: None. This article is originally published at Insider Monkey.