Pear Therapeutics (US), Inc.

PursueCare, a company that provides personalized virtual addiction treatment, announced the re-release of FDA-cleared RESET and RESET-O, prescription digital therapeutics for substance use disorder and opioid use disorder. RESET and RESET-O were initially developed and commercialized by Pear Therapeutics, which filed for Chapter 11 bankruptcy last year. PursueCare acquired the digital therapeutics offerings in December, several months after Pear's assets were auctioned off. According to PursueCare, the app-based digital therapies RESET and RESET-O provide a self-guided 12-week course of cognitive behavioral therapy whereby patients are motivated to complete lessons, comply with treatment and cease drug use. The company will leverage the PDTs jointly with its thorough virtual treatment offering, concentrating on value-based care arrangements with health plans. Additionally, PursueCare is establishing programs with partnering clinics to allow the delivery of RESET and RESET-O to their patients. RESET and RESET-O integrate with outpatient care to deliver uninterrupted support and customized progress tracking, according to PursueCare. Meanwhile, by enhancing patient engagement, the PDTs are designed to align with value-based care models prioritized by health plans. "At PursueCare, we are driven by the belief that everyone deserves accessible, high-quality care that meets them where they are and stays with them through their journey," Nick Mercadante, founder and chief executive officer of PursueCare, said in a statement. "RESET and RESET-O align perfectly with our mission. Digital therapeutics empower individuals to reclaim control over their health, advancing a new standard of care for chronic substance use disorder." THE LARGER TREND Pear's initial claim to fame was the 2017 De Novo clearance of its substance abuse treatment reSET, which marked the first prescription digital therapeutic to receive the agency's blessing. In 2018, reSET was the first software-only therapeutic cleared by the FDA. Pear hit the public markets in late 2021 through a merger with a special purpose acquisition company, but the company's stock price generally declined. In quarter three of 2022, Pear reported $4.1 million in revenue and a $30.7 million net loss. The company also said it had approved more layoffs, affecting 59 employees, or about 22% of Pear's workforce at the end of September. It had previously laid off 25 workers over the summer. Pear announced in March 2023 that it was exploring "strategic alternatives," including a possible company sale, merger or acquisition. It hired a financial advisor to look into actions that could "maximize shareholder value," including a potential sale, M&A, divestiture of assets, licensing or other strategic transactions. That same month, via a filing with the Securities and Exchange Commission, Pear withdrew its revenue and operating guidance for fiscal 2022 and 2023 and announced it wouldn't hold a fourth quarter and full-year earnings call. In April 2023, Pear filed for Chapter 11 bankruptcy and announced it was seeking a sale of its business or assets but would continue its scaled-down operations during Chapter 11 as it sought a sale. Pear would use its available cash to fund its operations and costs post-petition. A month later, the assets of Pear Therapeutics were broken up and sold at auction for $6.05 million in the wake of a bankruptcy filing by the company in April. According to the court filing, Pear's assets were split between four bidders: Digital therapeutics company Click Therapeutics, Harvest BIO, sleep tech company Nox Health Group and health technology company Welt. Harvest Bio was the successful bidder of Pear's Invention Science Fund licenses and patents, as well as its assets related to schizophrenia, multiple sclerosis, depression, major depressive disorder and other pipeline assets. Harvest also successfully purchased Pear's corporate trademarks, PearConnect, reSET and reSET-O assets. Harvest purchased the assets for an aggregate price of $2.03 million. In December of last year, PursueCare announced it completed a $20 million Series B funding round and acquired the digital therapeutics assets reSET and reSET-O, the products originally developed by Pear Therapeutics. The HIMSS Healthcare Cybersecurity Forum is scheduled to take place October 31-November 1 in Washington, D.C. Learn more and register.

A software app that modifies behavior through a series of lessons and exercises has received FDA clearance for treating patients with major depressive disorder, making it the first prescription digital therapeutic for this indication. The product, known as CT-152 during its development by partners Otsuka Pharmaceutical and Click Therapeutics, will be commercialized under the brand name Rejoyn. Rejoyn is an alternative way to offer cognitive behavioral therapy, a type of talk therapy in which a patient works with a clinician in a series of in-person sessions. In Rejoyn, the cognitive behavioral therapy lessons, exercises, and reminders are digitized. The treatment is intended for use three times weekly for six weeks, though lessons may be revisited for an additional four weeks. The app was initially developed by Click Therapeutics, a startup that develops apps that use exercises and tasks to retrain and rewire the brain. In 2019, Otsuka and Click announced a collaboration in which the Japanese pharma company would fully fund development of the depression app. Rejoyn does not replace drug therapy. The FDA decision covers the use of the digital therapeutic as an adjunct to antidepressant medication, which is how it was evaluated in a clinical trial. The antidepressant medications were not specified, though Otsuka’s portfolio has two of them: Abilify and Rexulti. The study enrolled 386 adults between the ages of 22 and 64 who were randomly assigned to use Rejoyn or a sham app for six weeks. The sham app included exercises but did not offer the cognitive behavioral therapy lessons or exercises such as those that are in Rejoyn. The main goal of the clinical trial was to measure the change in score (a higher score indicates worsening symptoms) according to a rating scale used to assess the severity of depressive episodes. According to a briefing document that Otsuka is providing to prescribers, the clinical trial results showed the average change in total score in the Rejoyn group was -9.03. However, that decrease in score was not statistically significant compared to the -7.25 score change in the sham group. In a four-week extension period, Otsuka said the effects from treatment showed “a trend favoring continued improvement.” No adverse events were reported from the clinical trial. Statistical significance is not an absolutely necessary for 510(k) clearance, a pathway that requires a medical device to demonstrate it is substantially equivalent to another device legally marketed in the U.S. “Substantial equivalence” means the new product has the same intended use as the predicate device and is as safe and effective as that predicate device. In an email announcing the FDA clearance of Rejoyn, Click Chairman and CEO David Klein said the clinical trial, named MIRAI, and the FDA clearance are examples of how digital therapeutics are positioned to help define the future of clinical care. “The MIRAI study validated Rejoyn’s novel treatment approach and was central to the FDA filing,” he said. “It is one of the largest studies completed to date on a digital therapeutic and one of the very few to evaluate a digital therapeutic’s effectiveness in a blinded comparison to a sham app that was designed to match the treatment in time, attention, and participant expectation of therapeutic effect.” The 510(k) pathway is the same one taken by Pear Therapeutics, which received clearances for apps developed for treating substance use disorder, opioid use disorder, and insomnia. A cognitive behavioral therapy app developed by Better Therapeutics for type 2 diabetes was authorized last year through the FDA’s De Novo pathway for devices that do not have a substantially equivalent predicate device. Despite passing regulatory muster, the apps from both Pear and Better failed to secure reimbursement from enough payers to make the products commercially viable. Pear sold its assets as part of bankruptcy proceedings last year. Unlike Pear, Better had taken its app all the way through Phase 3 testing, generating clinical data that executives said would be important for winning insurance coverage of the new technology. But Better ran out of time and money. In its third quarter 2023 financial report, Better said its cash reserves would last only through the first quarter of 2024. Within that time frame, the company expected to announce the first coverage decisions for its digital therapeutic. Those announcements never came. Two weeks ago, Better laid off its entire staff and said it would explore strategic alternatives, including the potential wind down of the company. Rejoyn will also need to show it can secure payer coverage. But unlike the digital therapeutics from Pear and Better, Rejoyn has the backing of a large company that already has a market presence in the indication cleared for the product. In an email, Otsuka spokeswoman Jill Roman said the company expects Rejoyn will become available for download from iOS and Android app stores this summer. Licensed prescribers will send prescriptions electronically to the pharmacy. Upon payment, the pharmacy will send the patient an access code that unlocks the treatment. Roman said Otsuka is unable to discuss pricing of the therapy at this time.

Otsuka Pharmaceuticals and Click Therapeutics announced that Rejoyn, a smartphone-based prescription digital therapeutic for major depressive disorder (MDD), scored FDA clearance to be used as an adjunct to clinician-managed care. Rejoyn is a six-week remote treatment program to help enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training and brief therapeutic exercises. The prescription digital therapeutic is expected to be released in the second half of 2024 and available for patients 22 years and older who are taking an antidepressant medication. "Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression," Dr. Brian Iacoviello, assistant professor in the department of psychiatry at Icahn School of Medicine at Mount Sinai and scientific advisor at Click Therapeutics, said in a statement. "When stronger and more balanced connections are created, the regions of the brain responsible for processing and regulating emotions are better able to work together and symptoms of depression can improve." THE LARGER TREND Otsuka and Click first partnered in 2021 for a clinical trial, which resulted in the Rejoyn app. Named the Mirai study, the goal was to measure digital therapeutics intervention effectiveness in adults with MDD. The same year, the Japan-based company collaborated with data science and digital health firm Holmusk for a three year collaboration. The partnership employed data analytics and AI on real-world data to drive a deeper understanding of unmet patient needs and real-world outcomes. A year later, Click Therapeutics partnered with Boehringer Ingelheim to co-develop and commercialize digital therapeutics for adult patients with schizophrenia. The deal garnered Click approximately $460 million in funds, and, in January, the FDA granted the pair breakthrough designation for a smartphone app CT-155. In 2021, Click raised $52 million in Series B funding, and the next year, secured a $15 million loan from Silicon Valley Bank, a year before the bank imploded making it the third largest bank failure in U.S. history. Click closed a $20 million loan from HSBC Innovation Banking last year, with the proceeds used to retire the company's previous term loan. The company said it would use the remaining balance to advance its prescription pipeline. Click Therapeutics was one of four bidders to win the assets of prescription digital therapeutics company Pear Therapeutics, which filed for bankruptcy last year. During an auction for the PDTx company's assets last year, Click obtained all Pear's platform patents, excluding those related to the ISF assets, for $70,000.