Centessa Announces Positive Interim Phase 1 Data for Orexin Receptor Agonist ORX750 in Sleep-Deprived Volunteers

Nxera Pharma Co., Ltd. (formerly known as Sosei Group or Sosei Heptares), based in Tokyo, Japan, and Cambridge, UK, has announced positive interim results from a Phase 1 clinical trial conducted by Centessa Pharmaceuticals. The study evaluated ORX750, an investigational drug aimed at treating sleep disorders, in acutely sleep-deprived healthy volunteers. These findings, reported on 10 September 2024, are significant as they demonstrate both the efficacy and safety of ORX750, which targets orexin receptor 2 (OX2R).

ORX750 is a highly potent and selective OX2R agonist designed using Nxera's proprietary technology. The drug is intended to address the loss of orexin neurons in narcolepsy type 1 (NT1) and holds potential for treating narcolepsy type 2 (NT2), idiopathic hypersomnia, and other sleep-wake disorders where orexin levels are normal.

The Phase 1 trial results indicated that ORX750 significantly improved the mean sleep latency at doses of 1.0 mg and 2.5 mg compared to a placebo. Specifically, the 2.5 mg dose restored normative wakefulness with a mean sleep latency of 32 minutes, as measured by the Maintenance of Wakefulness Test (MWT). This demonstrates that the drug can effectively help individuals remain awake during the day.

Additionally, the safety and tolerability profile of ORX750 was favorable. The trial did not report any frequently observed on-target adverse events associated with other OX2R agonists. There were no cases of hepatotoxicity or visual disturbances across all tested dose levels (1.0 mg, 2.0 mg, and 2.5 mg) up to the data cutoff date.

Following this promising interim data, Centessa plans to advance ORX750 into Phase 2 studies. These studies, set to begin in the fourth quarter of 2024, will involve patients with NT1, NT2, and idiopathic hypersomnia. Nxera will announce any milestone events that could result in material payments from Centessa to Nxera.

Nxera Pharma, rebranded from Sosei Heptares, is a biopharma company focused on developing new specialty medicines to address unmet medical needs in Japan and globally. The company boasts a diverse pipeline of over 30 active programs, spanning from discovery to late clinical stages. These initiatives focus on several medical fields, including neurology, gastrointestinal and immunological disorders, metabolic disorders, and rare diseases.

Nxera leverages its unique GPCR-targeted structure-based drug discovery platform, NxWaveTM, to identify best- or first-in-class drug candidates. The company employs over 350 people across key locations in Tokyo, Osaka, London, Cambridge, Basel, and Seoul, and is publicly listed on the Tokyo Stock Exchange under the ticker 4565.

By continually advancing their research and development efforts, Nxera aims to bring innovative treatments to patients in need, solidifying their position as a leader in biopharmaceutical innovation.

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