Centessa recently initiated the phase 1 clinical trial of ORX750, a highly potent and selective orexin receptor 2 agonist in development for the treatment of narcolepsy.


Summary: Centessa Pharmaceuticals reported first-quarter 2024 business highlights, including the FDA clearance of its Investigational New Drug application for ORX750, a selective orexin receptor 2 agonist for treating narcolepsy. The company initiated a phase 1 first-in-human clinical trial for ORX750 and plans to share proof-of-concept data from acutely sleep-deprived healthy volunteers in the second half of the year. CEO Saurabh Saha highlighted the potential of ORX750 to lay the foundation for broader applications in sleep-wake disorders and neurological conditions.

Key Takeaways: 

  • Centessa Pharmaceuticals received FDA clearance for its Investigational New Drug application and has initiated a Phase 1 first-in-human clinical trial for ORX750, a selective orexin receptor 2 agonist aimed at treating narcolepsy.
  • The company plans to release clinical proof-of-concept data from acutely sleep-deprived healthy volunteers in the second half of 2024, which could validate the potential of ORX750.
  • ORX750 has the potential to not only treat narcolepsy types 1 and 2 but also expand into other sleep-wake disorders such as idiopathic hypersomnia and broader neurological indications, according to CEO Saurabh Saha.

Centessa Pharmaceuticals plc, a clinical-stage pharmaceutical company, reported business highlights for the first quarter ended March 31, including updates on its orexin receptor agonist ORX750, in development for the treatment of narcolepsy.

During the quarter, the company announced that the US Food and Drug Administration cleared the Investigational New Drug application (IND) to initiate a phase 1 first-in-human clinical trial of ORX750 for the treatment of narcolepsy.

“2024 is off to a strong start for Centessa. Following clearance of our IND, we recently initiated the phase 1 first-in-human clinical trial of ORX750, a highly potent and selective orexin receptor 2 (OX2R) agonist for the treatment of narcolepsy, and remain on track with our goal to share proof-of-concept data in acutely sleep-deprived healthy volunteers in the second half of this year,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa, in a release. 

“We believe this study has the potential to deliver robust translational results that could lay the foundation for an orexin agonist clinical development program targeting narcolepsy type 1 and type 2 with the potential to expand into other sleep-wake disorders including idiopathic hypersomnia, as well as broader neurological indications.”

The company expects to share clinical proof-of-concept data in acutely sleep-deprived healthy volunteers in the second half of the year.

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