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Centessa to take narcolepsy drug into Phase 2 after no sign of side effects that doomed earlier competitor

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Centessa Pharmaceuticals plans to take its orexin receptor 2 agonist into mid-stage testing for narcolepsy after a Phase 1 study showed signs of efficacy.

The drug, ORX750, was tested in sleep-deprived healthy volunteers and showed positive results in helping them stay awake. Importantly, the company said Tuesday that there were “no observations of frequently reported on-target adverse events” that have been associated with the drug class.

The drug developer said it plans to start Phase 2 trials in the fourth quarter of this year in patients with narcolepsy type 1 and type 2, and also with idiopathic hypersomnia, a condition that’s marked by excessive sleeping and daytime sleepiness.

Side effects associated with the class have included visual disturbances and liver toxicities. Those liver effects led to the halt of work on a Takeda drug, TAK-994, back in 2021.

But the Japanese drugmaker earlier this year announced its own positive efficacy data from a related molecule, TAK-861, and has said it plans to take it into Phase 3 as soon as possible. Alkermes also has a drug in Phase 2 testing.

Editor’s note: This story contained an error describing the study’s endpoint and has been corrected.


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