Centessa Pharmaceuticals Gets FDA Approval to Begin Trials for New Neurology Drug ORX142

Centessa Pharmaceuticals Received US FDA Clearance

Image Credits: Seeking Alpha

Approval

Centessa Pharmaceuticals Plc, a clinical-stage pharmaceutical company, received a US Food and Drug Administration (FDA) IND clearance to initiate a phase 1 clinical study of ORX142 in healthy volunteers. The approval by the FDA is a discovery of new drugs and solutions supporting the healthcare market. Over the years, prominent drugs and therapies have been introduced and approved for the betterment and health safety of the patient. This accelerates the healthcare market and other suitable.

The New Investigational

The ORX142 is a new investigational, selective, and novel OX2R agonist that was discovered for the treatment of neurodegenerative and neurological disorders. ORX142 is one of the second drug candidates from the leading company’s multi-asset orexin franchise. The clinical trials will be initiated, starting with a phase 1 study that will check the pharmacokinetics, safety, and tolerability of multiple-ascending doses (MAD) and single-ascending doses (SAD) of ORX142 in healthy individuals. Opposite to the SAD, a placebo-controlled crossover pharmacodynamic (PD) assessment will be conducted by utilizing the Karolinska sleepiness scale and maintenance of wakefulness test in sleep-disturbed healthy adults. Further, the company is planning to opt for the first in-human phase 1 clinical study soon, with clinical data expected to be released this year.

The Centessa’s Orexin Receptor 2 Agonist Program

Orexin is a neuropeptide regulating the sleep-wake cycle. This leads to arousal and increased wakefulness. By integrating the orexin pathway with a novel orexin receptor 2 agonist, it identifies an approach to impaired attention, neuropsychiatric and neurodegenerative disorders, addressing excessive daytime sleepiness and cognitive deficits fatigue linked to vast neurological disorders. Centessa is generating a pipeline of capable OX2R agonists, consisting of ORX750 for sleep-wake disorders such as idiopathic hypersomnia (IH), narcolepsy type 1, and narcolepsy type 2. Additionally, for the treatment of select neurodegenerative and neurological disorders, ORX142, and for the treatment of neuropsychiatric disorders, ORX489 have been introduced.

Views and Statements

MD, Phd, Chief Executive Officer of Centessa, Saurabh Saha said, “The approval of our IND to conduct clinical studies of ORX142 is a milestone. It’s a beginning for a thrilling new phase in the clinical development of the company’s OX2R agonist pipeline, indicating beyond the study of rare hypersomnias.” Further, he said, “Along with our advanced OX2R agonist and advancement in the phase 2a crystal-1 study for the treatment of IH, NT1, and NT2, we are further looking forward to accelerating the company’s insights with the help of this new drug class and evaluating its overall performance and potential."