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Centessa Pharmaceuticals Initiates Phase 2 Trial of ORX750 for Sleep-Wake Disorders

• Centessa Pharmaceuticals has commenced a Phase 2 clinical trial of ORX750 for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia. • ORX750, an orally administered orexin receptor 2 (OX2R) agonist, was designed using Nxera Pharma's technology to target orexin neuron loss. • The trial initiation triggers a US$3.5 million milestone payment to Nxera Pharma, to be recognized as revenue in Q4 FY2024. • Nxera Pharma holds a significant equity stake in Centessa and is eligible for further milestone payments and royalties upon successful development of ORX750.

Centessa Pharmaceuticals has initiated a Phase 2 clinical trial evaluating ORX750, a novel, orally administered, highly selective orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia. The trial's commencement has triggered a US$3.5 million milestone payment to Nxera Pharma, Centessa's partner in the development of ORX750. This payment will be recognized as revenue for Nxera in Q4 FY2024.
ORX750 is designed to address the underlying pathophysiology of orexin neuron loss in NT1, and its potential applicability extends to NT2, idiopathic hypersomnia, and other sleep-wake disorders where orexin levels are normal. Narcolepsy is a chronic neurological disorder affecting the brain's ability to regulate the sleep-wake cycle, with NT1 characterized by a deficiency in orexin, a neurotransmitter that promotes wakefulness. Idiopathic hypersomnia is another sleep disorder characterized by excessive daytime sleepiness, even after long periods of sleep.
The ORX750 program originated from a strategic co-investment between Nxera and Medicxi in 2019. Nxera currently holds 929,353 shares in Centessa Pharmaceuticals, valued at approximately US$15 million. In addition to the potential appreciation of its equity holding, Nxera is also eligible for further milestone payments and royalty income tied to the successful development of ORX750.

Nxera Pharma's Perspective

Matt Barnes, EVP, President of Nxera Pharma UK and Head of R&D, commented, "This clinical development milestone with ORX750 is an important example of how our unique technology can be deployed to generate novel molecules with the potential to address unmet clinical needs. It also highlights the progress being made across the 12 clinical-stage programs in our extensive in-house and partnered portfolio. It is exciting to see this portfolio mature as it advances, and we look forward to reporting future milestones."

About Nxera Pharma

Nxera Pharma (formerly Sosei Heptares) is a technology-powered biopharmaceutical company focused on developing new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. The company has an extensive pipeline of over 30 active programs from discovery through to late clinical stage, both internally and in partnership with leading pharma and biotech companies. Nxera's pipeline is focused on addressing major unmet needs in neurology, GI and immunology, metabolic disorders and rare diseases, leveraging its GPCR-targeted structure-based drug discovery NxWaveTM platform.
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Reference News

[1]
Nxera Pharma's Partner Centessa Initiates Phase 2 Trial with ORX750, a Novel Orexin ...
biospace.com · Nov 12, 2024

Centessa Pharmaceuticals initiates Phase 2 trial of ORX750, an OX2R agonist for narcolepsy and idiopathic hypersomnia, t...

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