ORX142 / Centessa, Nxera Pharma - LARVOL DELTA

A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age (clinicaltrials.gov) - P1 | N=208 | Recruiting | Sponsor: Centessa Pharmaceuticals (UK) Limited

New P1 trial • Excessive Daytime Sleepiness • Sleep Disorder

Nxera Pharma to Receive US$4.8 Million in Milestone Payments Following Centessa’s Initiation of Clinical Development of ORX142, a Novel Orexin Receptor 2 (OX2R) Agonist (GlobeNewswire) - "Nxera Pharma...announces that it will receive US$4.8 million in milestone payments from Centessa Pharmaceuticals pursuant to its research collaboration with Centessa. The milestones were achieved as Centessa initiated clinical development of ORX142, its second novel orexin receptor 2 (OX2R) agonist, following the recent clearance of an Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for a Phase 1 clinical study of ORX142 in healthy volunteers. ORX142 is an investigational, novel, highly potent and selective OX2R agonist being developed by Centessa for the treatment of select neurological and neurodegenerative disorders. Of the milestone receipt, US$1.8 million associated with the clearance of the IND will be recognized as revenue in the second quarter of 2025, and US$3.0 million associated with the initiation of clinical development will be recognized as revenue in the third quarter of 2025."

Financing • Sleep Disorder

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 (GlobeNewswire) - "Centessa Pharmaceuticals plc...announced that the U.S. Food and Drug Administration (FDA) has cleared the IND to initiate a Phase 1 clinical study of ORX142 in healthy volunteers....The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX142 in healthy volunteers. In parallel to the SAD, a placebo-controlled crossover pharmacodynamic (PD) assessment will be performed utilizing the Maintenance of Wakefulness Test (MWT) and Karolinska Sleepiness Scale (KSS) in acutely sleep-deprived healthy adult subjects. The Company plans to initiate the first-in-human Phase 1 clinical study imminently, with clinical data expected this year."

IND • New P1 trial • Sleep Disorder

Centessa Pharmaceuticals Reports Business Highlights and Financial Results for the Fourth Quarter and Full-Year 2024 (GlobeNewswire) - "ORX142: Advancing through IND-enabling studies. The Company is focused on obtaining IND clearance and initiating clinical development with the goal of sharing clinical data in acutely sleep-deprived healthy volunteers in 2025."

Clinical data • IND • Sleep Disorder