Centessa Starts Phase 2 Trial for ORX750, an Orexin Receptor 2 Agonist

Nxera Pharma Co., Ltd. ("Nxera," TSE 4565), previously recognized as Sosei Group or Sosei Heptares, has announced that Centessa Pharmaceuticals has commenced a Phase 2 clinical trial for ORX750. ORX750 is an investigational drug administered orally and acts as a highly potent and selective orexin receptor 2 (OX2R) agonist. It is being developed to treat narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia.

As a result of this milestone, Nxera will receive a payment of US$3.5 million under its research collaboration agreement with Centessa. This will be recorded as revenue in the fourth quarter of the fiscal year 2024. The completion of this clinical milestone was noted in Centessa’s third-quarter financial results statement on 12 November 2024.

ORX750 was developed utilizing Nxera’s technology, aiming to address the loss of orexin neurons in NT1. The drug also holds potential for treating NT2, idiopathic hypersomnia, and other sleep-wake disorders where orexin levels remain normal.

The ORX750 initiative began as a strategic co-investment between Nxera and Medicxi, a life sciences investment firm, in 2019. This collaboration led to Nxera acquiring 929,353 shares in Centessa Pharmaceuticals, currently valued at approximately US$15 million. Nxera anticipates additional benefits from the potential increase in the value of its equity in Centessa, along with further milestone payments and royalty revenues linked to the success of ORX750’s development.

Matt Barnes, Executive Vice President and President of Nxera Pharma UK, as well as the Head of Research and Development, commented on the significance of this development. He pointed out that this milestone with ORX750 exemplifies how Nxera’s unique technology can create novel molecules that address unmet medical needs. Barnes also highlighted the progress across Nxera’s 12 clinical-stage programs, both internal and partnered. He expressed enthusiasm about the maturation and advancement of the company’s portfolio and looks forward to announcing future milestones.

Nxera Pharma, known previously as Sosei Heptares, is a biopharmaceutical company driven by technology. The company is dedicated to developing new specialty medicines that aim to improve the lives of patients in Japan and around the world who have unmet medical needs.

In addition to several products already being commercialized in Japan, Nxera is advancing a comprehensive pipeline of over 30 active programs. These programs range from the discovery phase to late clinical stages and are developed both internally and in partnership with leading pharmaceutical and biotech companies. The focus of this pipeline includes major unmet medical needs in rapidly growing areas of medicine, such as neurology, gastrointestinal and immunology disorders, metabolic diseases, and rare conditions. Nxera’s pipeline benefits from its proprietary GPCR-targeted structure-based drug discovery platform, NxWaveTM, providing a continuous source of best-in-class or first-in-class candidates.

Nxera employs over 350 professionals at significant locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland), and Seoul (South Korea). The company is publicly traded on the Tokyo Stock Exchange under the ticker symbol 4565.