Positive results announced in phase 2b trial of oral narcolepsy drug

Key takeaways:

• Treatment with TAK-861 resulted in clinically meaningful improvement in wakefulness compared with placebo at week 8.
• Takeda intends to initiate a phase 3 study of TAK-861 this year.

Takeda has announced positive topline results from a phase 2b trial evaluating an oral orexin receptor 2 agonist to treat individuals with narcolepsy type 1.

According to a company release, in a randomized, double-blind, placebo-controlled, multiple dose study evaluating TAK-861 in 112 patients, the novel therapy demonstrated statistically significant and clinically meaningful improvement in objective and subjective measures of wakefulness compared to placebo at week 8 including on the primary endpoint Maintenance of Wakefulness Test.

According to additional data reported in the release, those treated with TAK-861 showed improvements in secondary endpoints including Epworth Sleepiness Scale and Weekly Cataplexy Rate. A majority of study participants who completed the trial entered a long-term extension study.

TAK-861 was also found to be generally safe and well-tolerated, with no treatment-related serious adverse events. No cases of hepatotoxicity or visual disturbances were reported in either the phase 2b trials or the ongoing long-term extension, the company said in the release.

Based on these results, Takeda intends to initiate global phase 3 trials of TAK-861 for narcolepsy type 1 in the first half of fiscal year 2024.

“We are thrilled to announce these clear and compelling results from the TAK-861 trial in narcolepsy type 1,” Sarah Sheikh, MSc, BM, BCh, MRCP, head of global development at Takeda, said in the release. “We will continue to apply our deep and growing understanding of orexin biology as we work to develop and deliver transformative treatments to people across a range of indications who could benefit from this mechanism.”