Centessa Pharmaceuticals Announces Clearance of Investigational New Drug Application (IND) for ORX142, a Novel Orexin Receptor 2 (OX2R) Agonist; Clinical Data in Acutely Sleep-Deprived Healthy Volunteers Planned for this Year

Core Viewpoint - Centessa Pharmaceuticals has received FDA clearance to initiate a Phase 1 clinical study of ORX142, a novel OX2R agonist aimed at treating neurological and neurodegenerative disorders, marking a significant milestone in the company's drug development pipeline [1][2]. Group 1: Clinical Development - The Phase 1 study will assess the safety, tolerability, and pharmacokinetics of ORX142 in healthy volunteers, including single-ascending doses (SAD) and multiple-ascending doses (MAD) [2]. - A placebo-controlled crossover pharmacodynamic assessment will be conducted using the Maintenance of Wakefulness Test (MWT) and Karolinska Sleepiness Scale (KSS) in acutely sleep-deprived subjects [2]. - Clinical data from the Phase 1 study is expected to be available within the year, which will aid in dose selection for future studies involving patients [2]. Group 2: OX2R Agonist Program - Centessa's OX2R agonist program includes multiple candidates: ORX750, ORX142, and ORX489, targeting various sleep-wake disorders and neuropsychiatric conditions [3]. - ORX750 is currently in a Phase 2a study for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) [3]. - The orexin pathway is being targeted to address excessive daytime sleepiness (EDS), cognitive deficits, and fatigue associated with a range of neurological and neurodegenerative disorders [3]. Group 3: Company Overview - Centessa Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing transformational medicines, particularly in the area of OX2R agonists [4]. - The company is also exploring an early-stage immuno-oncology program utilizing its novel LockBody technology platform [4].