Pear Therapeutics Announces Data from Two Studies Evaluating Somryst™ for Chronic Insomnia Presented at Virtual SLEEP 2020

• Somryst is the first and only FDA-authorized prescription digital therapeutic (PDT) for the treatment of chronic insomnia.
• Findings from a large-scale, randomized controlled trial demonstrate that Somryst¹ can produce lasting improvements in sleep outcomes among adults with insomnia and depressive symptoms.
• A study analyzing user data from Somryst¹ found that predicting dropout of individual users early in the intervention is possible, potentially paving the way to help clinicians and PDTs identify those at risk of dropout to provide support for continuing engagement with treatment.

BOSTON & SAN FRANCISCO--(BUSINESS WIRE)--Pear Therapeutics, Inc. announced findings today from two studies of an experimental precursor of Somryst™ (called SHUTi) that evaluated effectiveness to improve sleep outcomes and analyzed user journey data to predict intervention dropout, respectively. Somryst is the first FDA-authorized prescription digital therapeutic (PDT) for the treatment of chronic insomnia. The study results were presented as part of Virtual SLEEP 2020, the 34^th annual meeting of the Associated Professional Sleep Societies LLC (APSS), which is a joint venture of the American Academy of Sleep Medicine and the Sleep Research Society.

Findings from a large-scale randomized controlled trial, Web-delivered CBT for Insomnia Intervention Improves Sleep Among Adults with Insomnia and Depressive Symptoms, show that Somryst can produce lasting improvements in sleep outcomes among adults with insomnia and elevated depressive symptoms.² These findings further support previous research that validated the utility of sleep diaries as a measure of treatment response.^3,4 The current study evaluated 1,149 Australian adults aged 18-64 years with insomnia and depressive symptoms for the effectiveness of SHUTi vs. an attention-matched control with improving sleep outcomes measured by prospectively entered sleep diary data.

Sleep diary data indicate that treatment with the PDT produced lasting improvements in sleep-onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE), number of awakenings, sleep quality, and total sleep time (TST) among adults with insomnia and elevated depressive symptoms. Importantly, these findings show not only statistically significant improvements in diary-derived variables but also clinically meaningful change, with both sleep-onset latency and wake after sleep onset falling below the 30-minute criterion in the treatment arm⁵ and total sleep time improving over time.

The digital nature of Somryst also offers new opportunities to probe the user experience at a granular level. A second study, Analyzing User Journey Data in Digital Health: Predicting Dropout from a Digital CBT-I Intervention, found that prediction of individual user dropout was possible early in the intervention, which may eventually help clinicians identify users at risk for dropping out and support continuing engagement with treatment.⁶ For this study, a collaboration with lead author Vincent Bremer at Leuphana University in Germany, data from a published randomized controlled trial⁷ evaluating effectiveness of Somryst were evaluated at each of six steps for a treatment arm of 151 participants to predict whether a user completed the full course of treatment.

“Research shows that Somryst use correlates with lasting improvements in sleep outcomes at 12 and 18 months for people suffering from chronic insomnia, and prospectively collected sleep diaries over time will allow us to refine therapeutic content and interfaces to support continuing engagement with treatment.,” said Yuri Maricich, M.D., Chief Medical Officer at Pear Therapeutics. “These studies provide additional evidence that PDTs can play a vital role in the treatment of people with chronic insomnia and break down the barriers to access guideline recommended first line treatment of care.”

Study Results for 0524 Web-delivered CBT for Insomnia Intervention Improves Sleep Among Adults with Insomnia and Depressive Symptoms:

• Data showed PDT participants demonstrated greater reductions from baseline to end of treatment compared with control for sleep onset latency (LS mean difference [95% CI]=-22.3 min [-29.2, -15.3]; p<.0001), wake after sleep onset (-17.8 min [-23.4, -12.3]; p<.0001), and number of awakenings (-0.38 [-0.68, -0.09]; p=.0113).
• PDT participants also showed greater improvements in sleep efficiency (9.18% [7.25%, 11.10%]; p<.0001) and sleep quality (0.41 [0.30, 0.53]; p<.0001) from baseline to end of treatment compared with control.
• Total sleep time was not significantly different between groups at end of treatment or 6-month follow-up, although it improved over baseline at 12 (18.73 min [7.39, 30.07]; p=.0013) and 18 months (23.76 min [9.15, 38.36]; p=.0015) relative to control.
• All other significant sleep treatment effects were maintained in the treatment arm at 6, 12, and 18-month follow-up.

Study Results for 1204 Analyzing User Journey Data in Digital Health: Predicting Dropout from a Digital CBT-I Intervention:

• Factors influencing dropout included aspects like length of time to complete a treatment core, difference between awake time and arising time at baseline, and number of email support exchanges.
• Accuracy of predicting dropout varied depending on point in time of prediction and the machine learning technique. After model evaluation, a decision tree (yes/no dropout) achieved Area Under Curve values ranging between 0.6-0.9 across six steps over the intervention (how-to-use tutorial through treatment Cores).
• Additional features (based on clinician input) contributed to prediction performance, including time to complete certain steps of the intervention, number of email exchanges, and time to get out of bed (difference between awake and arise times).

For more detailed information, please see the Virtual SLEEP 2020 Poster Gallery.

About Somryst

Somryst is a 9-week Prescription Digital Therapeutic (PDT) for chronic insomnia. Somryst can be used on a mobile device, such as a smartphone or tablet. Somryst is available by prescription only. A licensed Health Care Provider (HCP) must prescribe Somryst and use of Somryst should be undertaken only under the supervised care of an HCP.

Somryst Indications for Use and Important Safety Information

Somryst™ is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia – CBT-I) to patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms.

Safety Information and Warnings

Somryst™ is not for everyone. Please use your clinical judgement to determine whether Somryst is right for your patient.

• Somryst is not for emergency use. Please instruct patients to dial 911 or to go to the nearest emergency room in the event of a medical emergency,
• Patients should be clearly instructed not to use Somryst to communicate severe, critical, or urgent information to their Health Care Provider.
• Somryst is not meant to be used as treatment without supervision of a Health Care Provider.
• Somryst is not meant to be a substitution for any treatment medication.
• Somryst contains sensitive medical information. Please instruct patients to protect their information by password-protecting their smartphone and tablet, and ensuring no one else may access their device.
• Sleep Restriction (and Consolidation) within Somryst can cause sleepiness, especially in the early stages of using the PDT. Somryst should not be used if the patient needs to be alert or cautious to avoid serious accidents in their job or daily life. Examples include:
  • Long-haul truck drivers
  • Long-distance bus drivers
  • Air traffic controllers
  • Operators of heavy machinery
  • Some assembly line jobs
• The usage data collected in therapy lessons by Somryst are not intended to be used as a standalone assessment of treatment progress.

This press release does not include all the information needed to use Somryst safely and effectively. Please see the full Clinician Brief Summary Instructions for Somryst for more information.

About Pear Therapeutics

Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of Substance Use Disorder, was the first PDT to receive marketing authorization from FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst™, for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.

References:

1. Study evaluated the experimental precursor of Somryst called SHUTi.
2. Batterham, P.J., Christensen, H., Thorndike, F. P., Ritterband, L.M., Gerwien, R., Enman, N., Botbyl, J., Maricich, Y. Web-delivered CBT for Insomnia Intervention Improves Sleep Among Adults with Insomnia and Depressive Symptoms. Virtual SLEEP 2020.
3. Batterham PJ, Christensen H, Mackinnon AJ, et al. Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression. 2017;3:228-235. doi:10.1192/bjpo.bp.117.005231.
4. Carney C, Buysse DJ, Ancoli-Israel S, et al. The Consensus Sleep Diary: Standardizing prospective sleep self-monitoring. Sleep. 2012;35(2):287-302.
5. Espie CA, Inglis SJ, Harvey L. Predicting clinically significant response to cognitive behavior therapy for chronic insomnia in general medical practice: Analysis of outcome data at 12 months posttreatment. J Consult Clin Psychol. 2001;69(1):58-66.
6. Bremer V, Chow P, Funk B, Thorndike FP, Ritterband LM. Analyzing User Journey Data in Digital Health: Predicting Dropout from a Digital CBT-I Intervention. Virtual SLEEP 2020.
7. Ritterband LM, Thorndike FP, Ingersoll KS, et al. Effect of a web-based cognitive behavior therapy for insomnia intervention with 1-year follow-up: A randomized clinical trial. JAMA Psychiatry. 2017;74(1):68-75.