Takeda Discontinues Two Mid-Stage Narcolepsy Trials

  • Takeda Pharmaceutical Company Limited TAK has suspended dosing and has decided to stop Phase 2 studies evaluating TAK-994, an investigational oral orexin agonist.
  • According to Takeda, TAK 994 was undergoing two Phase 2 trials for narcolepsy Type 1 with cataplexy and narcolepsy Type 2 without cataplexy.
  • Type 1 narcolepsy is characterized by excessive daytime sleepiness plus cataplexy and/or low levels of a chemical in the brain called hypocretin.
  • Type 2 narcolepsy also results in excessive daytime sleepiness but does not have cataplexy and have normal hypocretin levels.
  • Takeda said that a safety signal has emerged in Phase 2 studies.
  • "Ensuring the safety of patients participating in clinical studies is of the utmost importance as we strive to develop transformative medicines. We are grateful to all of the patients, physicians, and site staff who participated in these important clinical trials," said Sarah Sheikh, Head Neuroscience Therapeutic Area Unit at Takeda. 
  • Takeda has one more oral orexin agonist in the pipeline, TAK-861, which is currently in Phase 1 development.
  • Related: Takeda In-Licenses Hunter Syndrome Candidate.
  • Price Action: TAK shares closed 0.25% lower at $16.08 on Tuesday.
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