NEW YORK, March 10, 2022–(BUSINESS WIRE)–Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced updates from several early research studies and development (R&D) in its Click Neurobehavioral Intervention (CNI) Platform™. Driving Click’s innovation in the development and delivery of digital therapies is an integrated R&D ecosystem comprised of multi-modal data collection tools and a scalable data analytics and machine learning infrastructure. Using proprietary passive and active sensing technology, the CNI platform generates personalized digital biomarkers and phenotypes to optimize the patient experience.

Click is committed to the continuous improvement of its CNI platform and the products derived from it, based on important information acquired through clinical learning studies. Clinical learning studies are exploratory studies designed to maximize learning about products and platforms. The qualitative user feedback and quantitative data generated from these studies help generate an ongoing pipeline of digital therapeutic engagement and effectiveness improvements. Recently completed successful studies include:

  • An exploratory study examining the optimal ways to establish a Digital Working Alliance (DWA) within the framework of therapeutic integration. Results from thirty trial participants identified key factors associated with establishing a strong DWA between a user and a digital therapeutic. These learnings are applied across Click’s portfolio to create a more engaging therapy experience for patients across multiple therapy areas.

  • A longitudinal momentary ecological intervention trial focusing on stress management, a transdiagnostic risk factor for many diseases (NCT04907942). Eighty-one trial participants with high levels of self-reported stress were randomized to receive either a) 3 weeks Ecological Momentary Assessment (EMA) (n=42) or b) EMA plus message-based intervention text for stress management (n=39). Early results show that retention and adherence to assessments in both groups were extremely high (>90%). About 70% of study participants in the intervention group said the messages helped them reduce their stress. The results of this study are used to improve personalized just-in-time (JIT) interventions on the CNI platform to target stress reduction. This study is currently due to be presented at the next annual meeting of the Society for Behavioral Medicine in April 2022.

  • A user preference and feasibility comparison study exploring methods of delivering digital therapeutic content to optimize engagement. Sixty adult trial participants with insomnia were randomized 1:1 to receive either a) short form (10 minutes commitment over 5 days) or b) long form (50 minutes commitment over 1 day ) delivery of therapeutic content for 2 weeks. The results of this study indicated a clear preference for shorter and more frequent engagement with therapeutic content with a statistical trend toward greater content recall in the short versus long form group at 2 weeks. This study was presented last year at the American Psychological Association’s conference on technology, mind and society.

Two other completed studies evaluated different versions of Click’s digital smoking cessation therapy: Clickotine® (CT-101) and Clickotine-MVP (CKT-M). CKT-M is a reduced version of Clickotine’s minimum viable product (MVP). In previous research, Clickotine was shown to help 26.2% of study participants quit smoking for 30 days at 8 weeks and 35.3% of study participants at 6 months. The two studies listed below were conducted online in a fully remote setting:

  • A clinical study of Clickotine-MVP (CKT-M) comparing its performance to a third-party smoking cessation app, QuitGuide (QG) from the National Cancer Institute (NCT03694327). Along with evaluating the quitting performance of both apps, a feasibility assessment of remote biochemical verification of smoking status with a smartphone-enabled wearable CO monitor was included in the study. The study recruited 158 smokers and randomly assigned them to either app. The Minimum Viable Product (MVP) version of an application includes the minimum set of features that meets user needs. The CKT-M study app featured a minimal one-way messaging and engagement platform, and importantly did not include personalized adaptive messaging or access to built-in nicotine replacement therapy (NRT) . Thus, CKT-M differed from versions of Clickotine used in previous research and used commercially. This study, which showed that the efficacy of CKT-M was not statistically different from HQ, established that CKT-M can serve as a stable, release-locked MVP comparator to Clickotine over time, compared to the performance of HQ. Using CKT-M as an internal comparator for development purposes will prevent comparator performance from drifting over time, which is a persistent issue when using third-party mobile apps as comparators in clinical studies of digital therapies. Additionally, the study demonstrated that those who reported being abstinent had significantly lower CO values ​​than those who reported light smoking, supporting the feasibility of biochemical verification of smoking status.

  • A clinical learning study of Clickotine in 78 smokers obtaining qualitative insights into the then-current version of CT-101 digital therapy (NCT04857515). In addition to qualitative feedback, quantitative data on withdrawal were also collected, although a formal efficacy analysis was not pre-specified as a study endpoint. In keeping with the nature of this trial, the study was not powered for efficacy analysis. However, for informal benchmarking purposes, a post-hoc efficacy analysis was performed. The results of this analysis are consistent with previous studies of Clickotine’s performance and confirm the application’s highest drop-out rate. Study participants were asked whether or not they were current smokers at 7, 14, and 30 days after the quit date. Of the 50 study participants who responded to at least one assessment after the quit date, 50% (n=25) reported at least one instance of abstinence and 24% (n=12) reported one. abstinence at the three times assessed (7, 14, and 30 days after stopping).

Finally, Click has completed or launched the following three studies on its Migraine (CT-132) program, leveraging and expanding its proprietary CNI platform in the process:

  • A successful cross-sectional and qualitative preclinical remote survey. This survey recruited 100 adult participants with episodic or chronic migraine to instruct digital therapeutic development, which focused on the role of psychological factors in migraine and factors related to the patient journey. The survey results regarding migraine-related disability, depression, anxiety and emotion regulation will be presented at the next annual meeting of the Society for Behavioral Medicine in April 2022.

  • A successful remote preclinical study using a new smartphone app from EMA. This study supported frequent longitudinal assessment in 100 adult participants with episodic or chronic migraine to test and validate theoretical mechanisms of migraine, in addition to advancing migraine prediction efforts. Data analysis is currently underway and will inform the development of digital biomarkers and digital phenotyping in migraine.

  • A single-arm exploratory study evaluating the effective establishment of a DWA in adults with episodic and chronic migraine. Study start-up activities are underway for the evaluation of 60 adult participants with an additional study objective to better understand the feasibility and acceptability of engagement with the mobile app to inform future development of the product.

“Click is excited to continue its investment in early and exploratory research and development with the expansion of our integrated R&D ecosystem and a broad range of clinical learning studies,” said Shaheen Lakhan, MD, PhD, Director Medical from Click. “These R&D efforts are designed to advance Click’s platform and improve the ability of our digital therapies to engage and treat patients. Internal research efforts are a central part of Click’s strategy to create a premier mobile platform for digital therapeutic development, deployment and continuous improvement.”

About Click Therapeutics

Click Therapeutics, Inc. develops, validates, and markets software as prescription medical treatments for patients with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enables change in individuals and is designed to be used independently or in conjunction with biomedical treatments. Clickometry® The adaptive data science platform continuously personalizes the user experience to optimize engagement and results. Following a breakthrough clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers and employers. Click’s lead prescription program has entered a pivotal, fully remote, randomized, controlled trial on the Verily platform for the treatment of major depressive disorder (MDD) in up to 540 adults. Click is advancing an extensive pipeline of Digital Therapeutics™ in a variety of high-load therapeutic areas including MDD, schizophrenia, migraine, chronic pain, atopic dermatitis, acute coronary syndrome (ACS), obesity and Moreover. For more information about Click, visit ClickTherapeutics.com.

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