Takeda releases two pivotal phase 3 study results of Oveporexton in Narcolepsy type 1

Takeda has recently announces that all of the primary and secondary endpoints were met in two Phase 3 randomized, double-blind, placebo-controlled studies of oveporexton , a potential first-in-class investigational oral orexin receptor 2-selective agonist, in narcolepsy type 1. NT1 is caused by the loss of orexin-producing neurons in the brain. Orexin agonists are designed to address this underlying orexin deficiency.

“We are thrilled to reach this pivotal milestone for the oveporexton program. Oveporexton is a testament to Takeda’s strength in discovering and developing a potential new class of medicines for difficult to treat diseases such as narcolepsy type 1,” said Christophe Weber, president and chief executive officer at Takeda. “Our leadership in orexin biology and building a multi-asset orexin franchise with transformative potential will position Takeda for long-term future growth.”

Note that Oveporexton was generally well-tolerated with a safety profile from the Phase 3 studies overall consistent with oveporexton studies to date including the Phase 2b study. No serious treatment-related adverse events were reported. The most common adverse events were insomnia, urinary urgency and frequency. More than 95 percent of the participants who completed the studies enrolled in the ongoing long-term extension study.

“We are grateful to the patients who took part in these clinical studies and to their families, the investigators and clinical staff. The studies were accelerated at an unprecedented pace with the aim to bring this potential treatment to people living with narcolepsy type 1 as quickly as possible,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “The comprehensive assessments from our Phase 3 studies build on the transformative results we saw with our Phase 2b study with most participants reaching normative ranges and reporting clinically meaningful improvement across a broad range of symptoms at the end of the 12-week treatment period. The positive results also reinforce the continued momentum for our late-stage pipeline, which we believe will deliver value to the patients we serve around the world.”

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Related Topics and Keywords

Oveporexton, TakedaOveporexton (TAK-861) in Narcolepsy Type 1