New Class of Sleep Drugs Shows Promise for Narcolepsy Treatment

Orexin-2 Agonists Demonstrate Significant Efficacy in Clinical Trials

A new era in sleep medicine is dawning as pharmaceutical companies present promising clinical trial data for drugs targeting the orexin-2 protein. These novel treatments, aimed at combating narcolepsy, have shown remarkable efficacy in keeping patients awake and reducing symptoms such as cataplexy.

Takeda Leads the Pack with Oveporexton

Takeda Pharmaceutical has emerged as the frontrunner in this new class of drugs with its candidate, oveporexton. In two late-stage clinical trials focusing on Type 1 narcolepsy, oveporexton met both primary and secondary goals. Patients receiving 2 mg doses twice daily showed clinically meaningful improvements, staying awake for 20 to 25 minutes during the Maintenance of Wakefulness Test, compared to falling asleep within five minutes at the study's start.

Additionally, oveporexton demonstrated significant reductions in cataplexy, a hallmark of Type 1 narcolepsy characterized by sudden loss of muscle control. Median weekly rates of cataplexy decreased by more than 80% for treated patients, with the median number of cataplexy-free days per week increasing from 0 to between 4 and 5.

Sarah Sheikh, Takeda's head of global development, emphasized the unprecedented nature of these results, stating, "This is the first time any drug in this field has ever shown this magnitude of effect."

Competitors Make Strides in Orexin-2 Drug Development

While Takeda may be leading the race, other pharmaceutical companies are making significant progress in developing orexin-2 agonists for narcolepsy treatment.

Alkermes presented data from a mid-stage study of its once-daily drug, alixorexton. After six weeks of treatment, patients receiving alixorexton stayed awake for 24 to 28 minutes during the Maintenance of Wakefulness Test, showing meaningful improvements in sleepiness and cataplexy.

Eisai also shared results from an early-stage study of its drug E2086, which demonstrated significant improvements in keeping patients awake compared to placebo and the existing medication modafinil.

As the field advances, these new orexin-2 agonists are poised to revolutionize narcolepsy treatment, offering hope to the estimated 120,000 patients in the U.S. alone who struggle with this challenging sleep disorder.