Summary: Takeda has initiated a phase 3 trial of TAK-861, an oral orexin receptor 2 agonist, for narcolepsy type 1, marking progress in its late-stage pipeline. Phase 2b results showed that TAK-861 significantly improved wakefulness and reduced symptoms in narcolepsy patients, with further R&D updates expected at Takeda’s R&D Day in December. Takeda’s first-half fiscal year 2024 performance exceeded expectations, allowing for increased R&D investment in the pipeline.
Key Takeaways:
- Phase 3 Trial of TAK-861 Begins: Takeda has advanced TAK-861, a promising treatment for narcolepsy type 1, to phase 3, focusing on improving wakefulness in affected patients.
- Phase 2b Success: Earlier trial results showed TAK-861 significantly improved wakefulness and reduced sleepiness and cataplexy, meeting primary and secondary endpoints.
- Increased R&D Investment: Strong first-half financial performance will enable Takeda to boost R&D spending, supporting the continued development of its late-stage pipeline.
Takeda announced earnings results and business highlights for the first half of fiscal year 2024, noting the advancement of its late-state pipeline with the start of a phase 3 trial of TAK-861, an investigational oral orexin receptor 2 agonist, in narcolepsy type 1.
More details on the company’s research and development strategy and pipeline updates, including commercial prospects, will be presented at Takeda’s R&D Day taking place on Dec 12.
“In the first half of fiscal year 2024, we made further progress in advancing our pipeline, including the initiation of our TAK-861 phase 3 trial for narcolepsy type 1. Our late-stage programs continue to advance, with several in phase 3 development this fiscal year, and have the potential to transform the lives of patients around the world,” says Takeda chief executive officer Christophe Weber in a news release.
Topline results from a randomized, double-blind, placebo-controlled, multiple-dose phase 2b trial evaluating TAK-861 in patients with narcolepsy type 1 in 112 patients demonstrated statistically significant and clinically meaningful improvement in objective and subjective measures of wakefulness compared to placebo at week eight including on the primary endpoint Maintenance of Wakefulness Test.
Improvements in key secondary endpoints including Epworth Sleepiness Scale and weekly cataplexy rate were statistically significant and clinically meaningful, consistent with the primary endpoint.
“We are upgrading our FY2024 full-year outlook, reflecting stronger than anticipated first-half performance as well as updated foreign exchange assumptions for the year. Full-year guidance reflects our intention to increase R&D investment in the second half to support our late-stage pipeline,” says Takeda chief financial officer Milano Furuta in a news release. “We remain confident in delivering sustainable growth with our Growth & Launch Products and promising late-stage pipeline.
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