Swiss biopharmaceutical firm Idorsia has reported positive results from a Phase II programme of ACT-541468 to treat patients suffering from insomnia.
ACT-541468 is a dual orexin receptor antagonist (DORA) designed to target the orexin system for maintaining natural sleep pattern.
The results showed that the Phase II programme has met its primary endpoint with a desired effect on sleep onset and maintenance, indicating a significant dose-response relationship.
The programme includes two placebo-controlled dose-response trials and assessed the safety and efficacy of ACT-541468 in a total of 418 adults and elderly subjects.
Idorsia managing director and chief scientific officer Martine Clozel said: “Its discovery is the result of an extensive effort to combine two important characteristics of a sleep medication: maintaining efficacy throughout the night, and a low potential for a next-day residual effect.
“I am delighted to see that the positive readouts from this comprehensive Phase II programme are consistent with our preclinical predictive models, for both adult and elderly patients with insomnia."
The programme’s first trial was conducted in 360 patients aged between 18 and 64 and demonstrated significant dose-dependent reduction of wake time after sleep onset (WASO) at days one and two, along with a dose-dependent decrease in latency to persistent sleep (LPS).
ACT-541468’s efficacy and safety profile, as well as its ability to significantly decrease WASO and LPS at days one and two, were validated in a second trial with 58 subjects aged 65-85.
During the programme, ACT-541468 was found to be well-tolerated without any serious adverse events.