Click Therapeutics Provides Research and Development Updates on Its Click Neurobehavioral Intervention (CNI) Platform

-Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics as prescription medical treatments, announced updates from multiple early research and development (R&D) studies across its Click Neurobehavioral Intervention (CNI) Platform. Driving Click’s innovation in digital therapeutic development and delivery is an integrated R&D ecosystem comprised of multi-modal data collection tools and a scalable data analytics and machine learning infrastructure. Through proprietary passive and active sensing technology, the CNI Platform generates personalized digital biomarkers and phenotypes to optimize patient experience.

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Click engages in continuous enhancement of its CNI Platform and the products built on it which is informed by important insights gained via clinical learning studies. Clinical learning studies are exploratory studies designed to maximize product and platform learnings. Qualitative user feedback and quantitative data generated from these studies help yield an ongoing pipeline of improvements to digital therapeutic engagement and efficacy. Recently completed successful studies include:

• An exploratory study examining optimal ways to establish a Digital Working Alliance (DWA) as part of therapeutic onboarding. Results from thirty trial participants identified key factors associated with establishing a strong DWA between a user and a digital therapeutic. These learnings are being applied across Click’s portfolio to build a more engaging therapeutic experience for patients across many therapeutic areas.
• A longitudinal Ecological Momentary Intervention trial focused on stress management, a transdiagnostic risk factor for many diseases (NCT04907942). Eighty-one trial participants with elevated levels of self-reported stress were randomized to receive either a) 3-weeks of Ecological Momentary Assessment (EMA) (n = 42) or b) EMA plus text message-based intervention for stress management (n = 39). Initial results show that retention and adherence to assessments in both groups was extremely high (>90%). About 70% of the study participants in the intervention group reported that the messages helped them reduce their stress. Results from this study are being used to enhance the personalized just in time (JIT) interventions on the CNI Platform to target stress reduction. This study is currently scheduled to be presented at the upcoming annual meeting of the Society for Behavioral Medicine in April 2022.
• A user preference and feasibility comparison study exploring methods of digital therapeutic content delivery to optimize engagement. Sixty adult trial participants with insomnia were 1:1 randomized to receive either a) a short form (10 minutes of engagement for 5 days) or b) a long form (50 minutes of engagement in 1 day) delivery of therapeutic content for 2 weeks. Results from this study indicated a clear preference for shorter, more frequent engagement with therapeutic content with a statistical trend towards greater recall of content in the short form versus long form group at 2 weeks. This study was presented last year at the American Psychological Association Technology, Mind, and Society Conference.

Two additional completed studies evaluated different versions of Click’s smoking cessation digital therapeutic: Clickotine (CT-101) and Clickotine-MVP (CKT-M). CKT-M is a reduced functionality minimum viable product (MVP) version of Clickotine. In previous research, Clickotine was shown to help 26.2% of study participants achieve 30-day smoking cessation 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 against a third-party smoking cessation application, the National Cancer Institute’s QuitGuide (QG) (NCT03694327). Alongside the evaluation of quit performance of the two applications, a feasibility assessment of remote biochemical verification of smoking status with a portable, smartphone-enabled CO monitor was included in the study. The study recruited 158 smokers and randomly assigned them to either one of the applications. The minimal viable product (MVP) version of an app includes the minimal feature set that meets user needs. The CKT-M study app featured a minimal 1-way messaging and engagement platform, and importantly did not include adaptive, personalized messaging or integrated nicotine replacement therapy (NRT) access. Thus CKT-M differed from Clickotine versions used in prior research and used commercially. This study, which showed that CKT-M was not statistically different in efficacy from QG, established that CKT-M can serve as a stable, version-locked MVP comparator to Clickotine over time, benchmarked against QG performance. Use of CKT-M as an in-house comparator for development purposes will prevent comparator performance drift over time, which is a persistent problem when using third party mobile applications as comparators in clinical studies of digital therapeutics. Further, the study demonstrated that those who reported abstinence had significantly lower CO values than those who reported some smoking, which supports the feasibility of biochemical verification of smoking status.
• A clinical learning study of Clickotine in 78 smokers gaining qualitative insights on the then-current version of the CT-101 digital therapeutic (NCT04857515). In addition to qualitative feedback, quantitative quit data were also collected, although a formal efficacy analysis was not pre-specified as a study endpoint. As per the nature of this trial, the study was not powered for an efficacy analysis. However, for informal benchmarking purposes, a post-hoc analysis of efficacy was conducted. Results of this analysis are consistent with previous studies of Clickotine performance and are supportive of the application’s industry-leading quit rate. Study participants were asked to report whether or not they were currently smoking at 7, 14, and 30 days post-quit date. Of the 50 study participants who responded to at least one post-quit date assessment, 50% (n=25) had at least one report of abstinence and 24% (n=12) reported abstinence at all three timepoints assessed (7, 14, and 30 days post-quit).

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

• A successful preclinical cross-sectional and qualitative interview remote survey. This survey enrolled 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. Survey findings regarding migraine disability, depression, anxiety, and emotion regulation will be presented at the upcoming annual meeting of the Society for Behavioral Medicine in April 2022.
• A successful preclinical remote study leveraging a novel EMA smartphone app. This study supported frequent longitudinal assessment in 100 adult participants with episodic or chronic migraine to test and validate theory-driven mechanisms in migraine, in addition to advancing migraine forecasting efforts. Data analysis is presently ongoing and will inform digital biomarker development 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 in evaluation of 60 adult participants with an additional study goal of gaining insights on feasibility and acceptability of engagement with the mobile application to instruct future product development.

“Click is excited to continue our investment in early and exploratory research and development with expansion of our integrated R&D ecosystem and a broad pipeline of clinical learning studies,” said Shaheen Lakhan, MD, PhD, Chief Medical Officer of Click. “These R&D efforts are designed to advance Click’s platform and enhance the ability of our digital therapeutics to engage and treat patients. In-house research efforts are a core element of Click’s strategy to build a best-in-class, mobile-first platform for digital therapeutic development, deployment and continuous improvement.”

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