Idorsia has announced encouraging top-line results from its Phase II dose-finding trial of daridorexant, a dual orexin receptor antagonist, aimed at treating pediatric insomnia disorder.
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The randomized study explored dosages of 10mg, 25mg, and 50mg in children aged 10 to under 18. It focused on assessing the dose-response relationship of the medication on total sleep time using polysomnography. The primary analysis revealed a statistically significant increase in total sleep time from baseline on day one.
A total of 165 patients participated in the trial, which included children aged 10 to 11 (21%) and 12 to 17 (79%). Many participants had neurodevelopmental disorders, including attention-deficit/hyperactivity disorder and autism spectrum disorders.
The study confirmed the safety and tolerability of daridorexant in pediatric patients, reporting no adverse events indicative of drug abuse during treatment or withdrawal symptoms after discontinuation. The safety profile at the maximum adult-recommended 50mg dose was comparable to placebo.
These findings may also suggest a broader role for orexin signaling in children with neurodevelopmental disorders, paving the way for new therapeutic strategies.
This trial is part of a pediatric study plan approved by the FDA and endorsed by the European Union Pediatric Committee (EU PDCO).
Idorsia plans to engage with health authorities to discuss next steps for pediatric insomnia and potential research pathways for children with neurodevelopmental disorders. Alberto Gimona, head of global clinical development and medical affairs at Idorsia, stated that these positive results indicate daridorexant’s strong, dose-dependent improvements in both objective and subjective sleep outcomes.
Gimona added that the safety data is particularly notable, as patients and caregivers reported no residual sleepiness the following morning, instead noting improved alertness.