ACTELION ANNOUNCES POSITIVE OUTCOME OF INSOMNIA TRIAL

Actelion announced that its Phase II proof-of-concept study in patients with primary insomnia receiving Orexin-OX1/OX2 receptor antagonist ACT-078573 has met its primary endpoint, an improvement in sleep efficiency measured by polysomnography.

This finding, obtained in the per-protocol analysis from 39 patients receiving the starting dose in this multicenter, multiple-stage, double-blind, randomized, placebo-controlled, two-way-crossover, single-dose study, was highly statistically significant, according to the company.

Treatment was well tolerated and there were no reports of serious adverse events and no emerging safety findings. As the per-protocol criteria for study continuation have been met, the study now has moved to the next stage and continues with the dose-finding part to establish the lowest effective dose.

After the ongoing study has identified the lowest effective dose, Actelion will analyze the trial in full detail and submit comprehensive results for publication in a peer-reviewed scientific journal.

By the end of the year, the company expects to generate all the information required to then start the large-scale pivotal Phase III program to evaluate the safety and efficacy of Actelion's Orexin-OX1/OX2 receptor antagonist ACT-078573 as a treatment for patients suffering from chronic insomnia.

ACT-078573 is the first oral orexin receptor antagonist that penetrates the blood-brain barrier and is capable of inducing a transient and reversible blockade of the two receptors, OX1 and OX2. Orexins are neuropeptides produced in the hypothalamus in the brain. Orexins play an important role in maintaining wakefulness and therefore regulate the sleep-wake cycle, according to the company.