JAPAN – Takeda Pharmaceutical is scheduled to advance its experimental drug TAK-861 into late-stage testing for the treatment of narcolepsy after reporting compelling results from recent studies.
The move singles out Takeda’s commitment to addressing unmet medical needs in narcolepsy treatment and tapping into a potentially lucrative market.
Narcolepsy, a neurological disorder characterized by excessive daytime sleepiness and sudden loss of muscle control, is categorized into two types.
Takeda’s drug, TAK-861, has been under evaluation for both types, with the company now focusing on advancing its development specifically for Type 1 narcolepsy.
Results from a Phase 2 trial involving 112 patients with Type 1 narcolepsy revealed that those treated with TAK-861 experienced statistically significant and clinically meaningful improvements in wakefulness compared to those who received a placebo.
Buoyed by these findings, Takeda plans to initiate Phase 3 trials in the first half of its fiscal year, slated to begin on April 1.
However, the outcome was different for Type 2 narcolepsy, where Takeda opted not to advance the program further.
The company is currently analyzing the data from the Type 2 trial to determine the next steps.
TAK-861 targets orexin receptors, proteins in the brain that play a crucial role in regulating wakefulness and arousal.
Previous attempts by Takeda and other pharmaceutical companies to develop narcolepsy treatments targeting orexin receptors have faced challenges, including adverse side effects such as liver toxicity and visual disturbances.
With TAK-861, Takeda aimed to develop a more tolerable therapy administered conveniently as a tablet.
The drug’s potency may allow for efficacy at lower doses, potentially reducing the risk of adverse effects.
Analysts speculate that Takeda’s decision to advance TAK-861 for Type 1 narcolepsy was driven by efficacy data, with safety concerns being carefully considered.
The market for narcolepsy Type 1 drugs is estimated to be worth over US$3 billion, highlighting the significant commercial potential of TAK-861.
Additionally, Takeda is already exploring the development of a successor drug, TAK-360, with a novel structure compared to TAK-861.
The company aims to initiate human testing for TAK-360 this year, positioning itself for further advancements in narcolepsy treatment based on emerging data.