Washington, DC-based Vanda Pharmaceuticals ($VNDA) has rounded up another batch of promising late-stage data for its experimental sleep therapy tasimelteon, setting the stage for an upcoming new drug application for the orphan drug.
The drug is designed to treat extremely rare cases of non-24-disorder, a condition in which the body's biological clock fails to work properly. It's an ailment that primarily afflicts the blind, making tasimelteon a prospective new orphan therapy--a hot category in the drug development world. Vanda reported a few weeks ago that the first of four late-stage studies on the drug was positive. Two more Phase III safety studies have yet to read out.
The biotech reported that "tasimelteon-treated patients maintained their clinical benefits while placebo-treated patients showed significant deterioration in measures of nighttime sleep, daytime naps, and timing of sleep."
Twenty patients were recruited for the study.
"These results clearly demonstrate that tasimelteon can entrain the circadian clock and continued treatment is necessary to maintain entrainment," said Steven W. Lockley, who works in the division of sleep medicine at Brigham and Women's Hospital. "The study also shows that entrainment is associated with meaningful clinical benefits and that maintaining entrainment of the master body clock is critical to treating the problems caused by non-24."
Vanda says it will file an NDA in the middle of this year.
- here's the press release