Takeda halts trials of touted sleep disorder drug over security issues

Diving letter:

  • Takeda, Japan’s largest drug company, announced Wednesday that it had stopped two mid-stage clinical trials of an experimental sleep disorder treatment as an “immediate precaution” after seeing a “safety signal”.
  • While Takeda disclosed few other details, it said that dosing was suspended by in the trials in order to better assess the potential risks and determine the next steps for the research program.
  • The drug called TAK-994 is under development for two types of narcolepsy and another sleep disorder called idiopathic hypersomnia. Takeda is developing two other treatments that are said to work similarly by activating a cellular switch in the brain.

Dive Insight:

TAK-994 is one of approximately a dozen compounds in Takeda’s “first wave” proposed revival of its research and development in cancer, rare diseases and neurological diseases. Takeda’s turnaround plan was accelerated in 2019 when the company completed its $ 62 billion acquisition of Shire, an orphan drug maker.

Early study data for a TAK-994-related compound seemed at the same time to bolster Takeda’s confidence that it would target orexin neurons, the loss of which is believed to lead to disorders such as narcolepsy.

TAK-994 and its related compound TAK-925 act as orexin “agonists” by activating a receptor in the brain and possibly restoring neurotransmitter activity.

Takeda’s orexin agonist treatments, along with a supposed therapy for rare epilepsy, form the neuroscientific portion of the “first wave” pipeline and are projected by the company as potential sales opportunities in the billions.

For the time being, however, the TKA-994 test will be suspended as Takeda is analyzing the safety data it has collected so far.

“We are working to quickly assess all of the available data to support the further development of TAK-994,” said Sarah Sheikh, director of neuroscience for the company, in a .

The two studies Takeda has suspended appear to be Phase 2 clinical trials in adults with two types of narcolepsy. The first started in September 2019, the second in March.

The results should serve as the basis for the design of a phase 3 study and help to support the further development of the drug to the regulatory authorities until 2024.

If successful, Takeda’s narcolepsy treatment would compete with three products marketed by Jazz Pharmaceuticals. Meanwhile, the Alkermes biotech is preparing to test an orexin agonist in narcolepsy.

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