Finnish pharmaceutical company Orion Corporation (HEL:ORNBV) announced on Tuesday that its candidate ODM-105 (tasipimidine) did not meet the primary goal in the clinical Phase 2 UNITAS study for the treatment of patients with insomnia.

According to the study results, ODM-105 did not significantly improve insomnia-related symptoms such as time to fall asleep or sleep duration compared with placebo. ODM-105 was generally safe and well tolerated. Detailed results, including safety data, and their assessment have not yet been finalised.

Based on the findings, Orion will discontinue development of ODM-105 for insomnia.

"We are disappointed that our study did not meet its primary goal. Our biggest regret is that we're not able to provide a new and more efficient treatment option for people suffering from insomnia," said Professor Outi Vaarala, Orion executive vice president of Innovative Medicines and Research & Development at Orion. "Recruitment for the UNITAS study was faster than expected, which enabled an earlier read-out of efficacy signals. On the other hand, it also reflects the huge unmet need for new insomnia treatments that still remains. We will focus our efforts and resources on advancing our other assets both in research and clinical phases."

UNITAS is a Phase 2b randomised, triple-blind, and placebo-controlled trial evaluating the safety and efficacy of ODM-105 (tasipimidine) compared with placebo in 153 adult patients diagnosed with insomnia disorder. The endpoints of the study are wake after sleep onset (WASO) and latency to persistent sleep (LPS), measured via polysomnography.