Pear Therapeutics (Nasdaq:PEAR) today announced real-world data from a trial of its Somryst prescription digital therapeutic (PDT).
Data showed that Somryst, the only FDA-authorized PDT for treating chronic insomnia, achieved significant reductions in symptoms of insomnia, anxiety and depression severity both immediately following treatment and at six-months follow-up.
Boston-based Pear Therapeutics presented results at the 36th Annual Meeting of the Associated Professional Sleep Societies (APSS) in Charlotte, North Carolina, according to a news release.
“Chronic insomnia is often associated with depression and anxiety so it’s important to evaluate the impact of insomnia treatment on such psychiatric comorbidities. We seek to measure not only impact on nighttime sleep but also effect on daytime impairment,” Pear Therapeutics CMO and Head of Development Dr. Yuri Maricich said in the release. “We’re encouraged by the durable response seen in this interim real-world analysis of cognitive behavioral therapy for insomnia delivered by Somryst and look forward to seeing additional data from the DREAM trial.”
Interim data from the DREAM remote, virtual, open-label, decentralized clinical trial evaluating Somryst came from 993 adult patients (between 22 and 75 years old) enrolled to date with chronic insomnia living in the U.S. who had access to a mobile device.
The data cutoff for the interim analysis was January 20, 2022, with results demonstrating that patients treated with Somryst for nine weeks with digitally delivered first-line guideline-recommended cognitive behavioral therapy for insomnia experienced a significant decrease in the symptoms of insomnia severity immediately after treatment and six months later.
Additionally, Pear Therapeutics reported that scores of depression and anxiety decreased significantly at both time markers, with the largest observed decreases in Generalized Anxiety Disorder (GAD-7) and Patient Health Questionnaire depression scale (PHQ-8) scores among people with more severe symptoms.
Previous interim data from the DREAM study, presented in March, showed that, in 779 patients who completed end-of-treatment, the population achieved statistically significant and clinically meaningful reductions in insomnia severity, sleep onset latency and wake-after-sleep onset from baseline to post-treatment at nine weeks.
Among the 193 patients who completed the six-month follow-up, significant improvements in all three of those categories were maintained.