Takeda's Oveporexton Shows 100% Success in Phase III Trials for Narcolepsy

Takeda Pharmaceutical Company Limited has announced positive results from two pivotal Phase III studies of Oveporexton (TAK-861), a potential first-in-class, investigational, orally administered, selective orexin 2 receptor (OX2R) agonist for the treatment of type 1 narcolepsy (NT1).

NT1 is a neurological disorder caused by the loss of orexin-producing neurons in the brain, leading to excessive daytime sleepiness and sudden sleep attacks. The two Phase III studies, FirstLight and RadiantLight, were conducted across 19 countries. Both studies met all primary and secondary endpoints, demonstrating statistically significant improvements in symptoms across all doses compared to the Phase IIb results. The safety data from the Phase III studies indicated that Oveporexton was generally well-tolerated.

Oveporexton is designed to address the potential orexin deficiency caused by the loss of orexin-producing neurons. This mechanism of action was validated for the first time in Phase III studies, significantly improving a range of clinical symptoms and further demonstrating Oveporexton's potential to change the standard of care for NT1.

Christophe Weber, President and Chief Executive Officer of Takeda, expressed his satisfaction with the achievement of this key milestone in the development of Oveporexton. He highlighted Takeda's leadership in the field of orexin life sciences and its commitment to driving significant changes through a diversified orexin product pipeline. This leadership position is expected to ensure the company's long-term, steady growth in the future.

The positive outcomes from these studies represent a significant milestone for Takeda, bringing the company one step closer to potentially offering a new treatment option for patients suffering from NT1. The results underscore the potential of Oveporexton as a novel therapeutic approach for managing the symptoms of this debilitating condition. With these encouraging findings, Takeda is poised to advance the development of Oveporexton, potentially providing a much-needed solution for patients who currently have limited treatment options.