Actelion's orexin blocker insomnia drug shows very strong efficacy in Phase II trial

Swiss drugmaker Actelion's orexin receptor antagonist, ACT-078573, improved patient's sleep in a Phase II trial, with no safety concerns observed. The finding, obtained from a per protocol analysis of 39 patients in a multicenter, multiple-stage, double-blind, randomized, placebo-controlled, two-way crossover, single-dose study, was highly statistically significant (p<0.0001).

On the day the results were announced, February 5, shares in Actelion rose 5.9% to 314.09 Swiss francs and climbed a further 3.5%, to 325.00 francs, the following day.

Actelion noted that treatment was well-tolerated and, as the per protocol criteria for continuation have been met, the study has moved to the next stage and continues with the dose-finding phase to establish the lowest effective dose, at which point the firm will analyze the trial in full detail and submit comprehensive results for publication in a peer-reviewed scientific journal. On the strength of this promising data, Actelion has accelerated its efforts to advance this compound into the final stages of development.