Pear Therapeutics Announces Data from Two Studies Evaluating Prescription Digital Therapeutics (PDTs) for Chronic Insomnia Presented at World Sleep Congress 2022

Rhea-AI Summary

Pear Therapeutics (Nasdaq: PEAR) announced significant interim results from studies of its FDA-authorized digital therapeutic, Somryst®, for chronic insomnia. The DREAM study reported a mean insomnia severity index (ISI) reduction from 18.8 to 11.3 after nine weeks, with sustained improvements through six months. Furthermore, 78.7% achieved remission in sleep onset latency. An additional study highlighted that older adults using the tailored version, SHUTi-OASIS, also experienced significant insomnia reductions over 12 months. These findings underscore the growing importance of accessible, remote treatments.

Positive

• Significant reduction in insomnia severity (ISI) from 18.8 to 11.3 in the DREAM study.
• 78.7% of participants achieved clinically meaningful remission in sleep onset latency.
• Sustained improvements in insomnia severity maintained through six months.
• Older adults using SHUTi-OASIS showed significant reduction in ISI over 12 months.

Negative

• None.

• Interim data from DREAM, a fully virtual, decentralized study, found treatment with Somryst® achieved significant and meaningful reductions in insomnia severity through six months¹

• Results from a study evaluating older adults with chronic insomnia, SHUTi-OASIS, demonstrated, significant and meaningful reductions in insomnia severity through 12 months compared to control condition²

BOSTON--(BUSINESS WIRE)-- Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced data that further underscore the effectiveness of Somryst®, the only FDA-authorized PDT for the treatment of chronic insomnia. Results were presented in a symposia at World Sleep 2022, the international Congress of World Sleep Society, on March 15 in Rome, Italy.^1,2

“Today, many people face barriers to accessing care so the opportunity to provide patients with 24/7 virtual access to proven treatment options is more important than ever,” said Yuri Maricich, M.D., Chief Medical Officer & Head of Development at Pear Therapeutics. "It’s critical to examine the impact of prescription digital therapeutics among people with chronic insomnia, particularly given the toll lack of sleep can take on day-to-day activities and overall quality of life, including leading to depression, suicidality, hypertension and even heart attacks.”

Interim data from the DREAM study (NCT04325464), a remote, virtual, open-label, decentralized clinical trial evaluating Somryst, analyzed in mid-Q1 2022, had 991 patients enrolled to date. In 779 patients who completed end-of-treatment (EOT), the population achieved statistically significant and clinically meaningful reductions in insomnia severity (ISI), sleep onset latency (SOL), and wake-after-sleep onset (WASO) from baseline to post-treatment at nine weeks, and in the 193 patients who completed the 6 months follow-up, significant improvements in ISI, SOL, and WASO, were all maintained through six months.¹ As part of its PearCreate™ platform, Pear has developed its own decentralized and fully virtual clinical trial infrastructure for participant recruitment, screening, consent, enrollment, follow up, and progress tracking, which was used for the DREAM study.

Study Results presented at S31: Digital Delivery of CBT for Insomnia: An International Perspective:

• Interim data showed of participants treated with Somryst, the mean ISI at baseline was 18.8 and at EOT was found to be 11.3 (Cohen’s d = 1.4 (1.3 – 1.5), and at 6 months 12.1 (Cohen’s d = 1.2 (1 – 1.4) (p<0.0001), where Cohen’s effect sizes over 1.0 are also considered large treatment effects.¹
• By end of treatment, 78.7% and 73.3% of participants treated with Somryst achieved the American Academy of Sleep Medicine (AASM) clinically meaningful definition of SOL remission (falling sleeping within 30 minutes or less) and/or WASO remission (waking up during the night for 30 or fewer minutes), respectively.¹

These results are interim, additional results will be reported on in the future, upon completion of enrollment and patients reaching subsequent follow-up assessment periods.

“The ability to capture real-world data in a fully remote setting due to the COVID-19 pandemic allowed us to really understand the value that access to remote treatment options have in successfully treating chronic insomnia,” said Charles M. Morin, Ph.D., Professor, Laval University, and Director, Centre d'étude des troubles du sommeil in Québec, Canada. “These results demonstrate that cognitive behavioral therapy, the recommended first line treatment of care for chronic insomnia, can be effectively delivered through a PDT like Somryst, helping patients treat their chronic insomnia.”

An additional study evaluating older adults (55 years of age or older) with chronic insomnia was also presented. In this trial, patients used an earlier version of Somryst (previously called SHUTi, that was tailored for older adults, and so is called SHUTi-OASIS). Most participants were female (68.5%) with an average age of 66.3 years and 13.5 years of sleep difficulties.² The majority of the 311 older adults with insomnia (OAWI) completed all six treatment cores (85%).

Specific Study Results for O23: An RCT of an Internet Intervention for Insomnia Tailored for Older Adults (SHUTi-OASIS):

• Results found treated participants achieved significant reductions in ISI score (15.9 at baseline, 10.0 at ten weeks, 9.1 at six months and 8.9 at 12 months) compared to participants who received PE (16.2 at baseline, 15.1 at ten weeks, 14.0 at six months and 13.2 at 12 months) (p<.001).²
• Similar patterns in WASO, SOL, sleep efficiency and sleep quality were also demonstrated.²

“These results provide strong evidence that older adults living with insomnia both use and obtain significant benefits from an interactive, remote program to treat their chronic insomnia, without needing special assistance,” said Lee Ritterband, PhD, Professor and Director of the Center for Behavioral Health & Technology, University of Virginia School of Medicine in Charlottesville, Virginia. “These results demonstrate the value of remote interventions for chronic insomnia for older adults living with insomnia who may not otherwise have access to clinically validated treatment options like CBTi.”

For more information and to view the presentations, please visit www.worldsleepcongress.com.

About Somryst®

Somryst is the only FDA-authorized therapeutic that delivers guideline recommended first-line treatment for chronic insomnia. Somryst is a 9-week prescription digital therapeutic (PDT) that addresses the underlying issues of chronic insomnia by delivering cognitive behavioral therapy for insomnia (CBTi), an evidence-based approach that trains the brain and body to sleep. The American Academy of Sleep Medicine and the American College of Physicians clinical guidelines recommend CBTi as first-line treatment for people with chronic insomnia.^3,4 Somryst is used on a mobile device, such as a smartphone or tablet and 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, 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.

Note: In the early stages of treatment, increased daytime sleepiness may be expected, but is usually temporary. Please instruct the patient to consult with their Health Care Provider if these experiences do not go away over a few weeks, as it may indicate that they have another sleep disorder or medical condition other than insomnia. Please instruct the patient that if they have trouble staying awake while performing potentially dangerous tasks (like driving) at any point in the treatment, to avoid these dangerous tasks or stop following the sleep restriction component of the therapy. 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, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of 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 the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the 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.

Forward-Looking Statements

Certain statements and projections in this press release may be considered forward-looking statements within the meaning of the federal securities laws. Forward looking statements generally relate to future events or involving, or future performance of, Pear. For example, statements that patients using Somryst will experience significant and meaningful reductions in insomnia severity through 6 or 12 months’ usage are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “aim”, “estimate”, “anticipate”, “believe”, or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements.

These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Pear and its management are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) delay or reluctance by patients and/or providers to adopt, request or use Pear’s products, (ii) whether Pear’s PDTs will improve healthcare access, (iii) the possibility that Pear may be adversely affected by other economic, business, regulatory, and/or competitive factors; (iv) the evolution of the markets in which Pear competes; (v) the impact of the COVID-19 pandemic on Pear’s business; (vi) changes in applicable laws or regulations; and (vii) other risks and uncertainties set forth in Pear’s future filings with the SEC. These filings will identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

Readers are cautioned not to put undue reliance on forward-looking statements, and Pear assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Pear gives no assurance that Pear will achieve its expectations. The inclusion of any statement in this communication does not constitute an admission by Pear or any other person that the events or circumstances described in such statement are material.

References:

1. Morin, C. Early data from a prescription digital therapeutic delivering CBT for insomnia. World Sleep Congress 2022.
2. Ritterband, L., Shaffer, K., Thorndike, F., et. al. An RCT of an Internet Intervention for Insomnia Tailored for Older Adults (SHUTi-OASIS). World Sleep Congress 2022.
3. Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008;4(5):487-504.
4. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016; 165:125–133.

 

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Media and Investors:

Meara Murphy

Senior Director, Corporate Communications

meara.murphy@peartherapeutics.com

Golin

golinpear@golin.com

Source: Pear Therapeutics, Inc.

FAQ

What were the key findings from Pear Therapeutics' DREAM study for Somryst?

The DREAM study showed significant insomnia severity reduction, with the insomnia severity index (ISI) decreasing from 18.8 to 11.3 after nine weeks and sustained through six months.

How effective is Somryst for older adults with chronic insomnia?

In the SHUTi-OASIS study, older adults experienced significant insomnia severity reductions over 12 months.

What percentage of participants achieved remission using Somryst in the DREAM study?

In the DREAM study, 78.7% of participants achieved clinically meaningful remission in sleep onset latency.

What is Somryst and how does it work?

Somryst is an FDA-authorized digital therapeutic delivering cognitive behavioral therapy for insomnia (CBTi) and is prescribed to treat chronic insomnia.

When were the results of the studies for Somryst presented?

The results were presented at the World Sleep 2022 Congress on March 15.