Centessa Pharmaceuticals has received FDA clearance to begin a Phase 1 clinical trial of ORX142, a new OX2R agonist, in healthy volunteers. This marks the second drug candidate from their orexin franchise, focusing on neurological and neurodegenerative disorders. The trial will assess ORX142’s safety, tolerability, and pharmacokinetics in healthy volunteers, including pharmacodynamic assessments using the Maintenance of Wakefulness Test and Karolinska Sleepiness Scale in sleep-deprived subjects.
This advancement is crucial because it expands Centessa’s orexin program beyond rare sleep disorders like narcolepsy, which their lead candidate, ORX750, currently targets. Successfully demonstrating ORX142’s efficacy in promoting wakefulness in this initial trial could unlock its potential for treating broader neurological conditions characterized by fatigue, impaired attention, and cognitive deficits, where significant unmet medical needs exist. This potentially opens avenues for addressing conditions like Alzheimer’s, Parkinson’s, or multiple sclerosis, where these symptoms are prevalent and negatively impact patients’ quality of life.
The Phase 1 study comprises single-ascending and multiple-ascending dose evaluations. Alongside the single-ascending dose portion, a placebo-controlled crossover study will assess the drug’s impact on wakefulness in sleep-deprived individuals. Centessa anticipates initial clinical data from this trial later this year, paving the way for dose selection in subsequent patient studies.
This development positions Centessa to potentially establish a leadership position in utilizing OX2R agonists for a wider range of neurological conditions. Positive results from the Phase 1 trial could catalyze further investment and research into this therapeutic area, potentially leading to new treatment options for debilitating neurological symptoms. The data generated this year will be essential for shaping the future development trajectory of ORX142 and solidifying the potential of Centessa’s orexin platform.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
