Click Therapeutics Shares 2022 Accomplishments and Development Progress in its Prescription Digital Therapeutics Programs

2022-12-23

NEW YORK – December 23, 2022 – Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today shared multiple accomplishments and advances in its research and development (R&D) programs. Over the past year, Click has broadened and accelerated its digital therapeutic R&D programs, supporting initiation or completion of 10 clinical trials across 9 therapeutic areas including neurology, oncology, inflammatory disease and serious mental illness. In sum, Click has enrolled more than 1,000 patients in early and late stage studies. Click’s R&D efforts represent a continued commitment to building prescription digital therapeutics that integrate clinical science with patient-centric design to build efficacious and engaging treatments in therapeutic areas with high unmet need, combined with the rigors of traditional therapeutic development. Highlights from the year include:

Launch of Click’s Digital Neuro-activation and Modulation (DiNaMoTM) neurobehavioral intervention program to enable new therapeutic areas. Click’s DiNaMo program develops and evaluates digital mechanisms of action targeted to one or more neural pathways implicated in disease expression. The DiNaMo program was conceptualized, developed, and validated at Click by a multidisciplinary team with backgrounds in neuroscience, serious gaming, medicine, and mobile application development. Click completed enrollment and study assessments for two randomized, controlled, fully decentralized DiNaMo studies in 2022. The first was a basket study evaluating the impact of a cognitive intervention on gold-standard objective outcomes in participants with multiple sclerosis or breast or lung cancer, indications that share cognitive dysfunction as a factor of disease progression or treatment. Clinically-meaningful changes in outcomes of interest have been observed in each indication, supporting opportunities for further development within these therapeutic areas. The second basket study evaluated an attention modification task in conditions that share chronic-pain as a transdiagnostic feature including diabetic neuropathy, irritable bowel syndrome, fibromyalgia, and rheumatoid arthritis. The protocol for this study was presented at CNS Summit in November 2022. The study recently completed enrollment in December with data analysis now underway.

Implementation of advanced in-house clinical operations capabilities. Central to the design and validation of Click’s digital therapeutics treatments are the company’s successful clinical operations, including both hybrid and fully decentralized approaches to study capabilities. “Click Clinical Operations is highly focused on leveraging technology in the planning and conduct of our clinical trials. Using validated tools and multi-channel engagement strategies for all stages of research reduces study costs, resource needs and time to execute. Our decentralized trials meet the participant on their schedule and on their terms to garner trial data reflective of how people live while seeking treatment,” said Cathleen Platt, Click’s Vice President of Clinical Operations. As a measure of success of these operational capabilities, Click saw enrollment completed in an average of 2.3 months for Click managed studies.

Ongoing development of digital therapeutics to treat serious mental illness. Click continues to advance studies in schizophrenia (CT-155) and major depressive disorder (CT-152) in partnership with Boehringer Ingelheim and Otsuka, respectively. Results from Click and Boehringer Ingelheim’s first clinical learning study were presented at Psych Congress and Neuroscience Education Institute in 2022. As recently announced, this and other supportive data across additional clinical learning studies have contributed to the expansion of Click’s partnership with Boehringer Ingelheim to include development of an additional digital therapeutic.

Progress in developing a digital therapeutic for Migraine (CT-132). The migraine program recently received Breakthrough Device Designation (BTDD) from the U.S. Food and Drug Administration that will enable expedited development and review. BTDD submission was supported by a series of studies that demonstrated robust patient engagement with precursor versions of the digital therapeutic. The first study leveraged smartphone based ecological momentary assessment and passive data sensing to establish the framework for study app data and biometric parameter collection. The second study evaluated the impact of an abbreviated version of the digital therapeutic on establishment of a Digital Working Alliance (DWA) and exploratory measures of clinical efficacy. The outcomes of this study support the probability of clinical success for CT-132 and were instrumental in achieving BTDD designation. Click expects to share the full results of these studies following completion of additional clinical trials in the migraine program, including an upcoming pivotal registration study utilizing gold-standard endpoints common in pharmaceutical registration studies.

Expansion of Click’s intellectual property portfolio. In 2022, Click was awarded 11 granted patents and filed 11 patent applications worldwide, further strengthening the company's growing intellectual property (IP) portfolio. These efforts demonstrate Click's commitment to quality innovation and will expedite the commercial importance of its proprietary, cutting-edge technologies and inventions. In the next year, Click looks forward to continuing to build its IP position with a number of new patents currently in preparation.

Partnering with strategic organizations to enable digital therapeutic adoption. Earlier in the year, Click partnered with Altoida to support clinical research leveraging their augmented-reality technology to assess brain health across Click’s pipeline, accelerating insights into individual's patterns of disease. Furthering the mission to democratize access to high-quality care, Click partnered with The Massachusetts Medical Society (MMS). Founded in 1781, the MMS is the statewide professional association for physicians and medical students with over 25,000 members and publisher of the New England Journal of Medicine. This collaboration aims to advance the practice of medicine, whereby Click sponsors the MMS Information Technology in Medicine Award and advances discussions with MMS membership to responsibly leverage technology in systems of healthcare.

“2022 has been a breakout year for Click. We have successfully launched our own decentralized clinical trial platform, advanced assets from discovery to late-phase studies, validated our distinctive approach to therapeutic development with breakthrough device designation, and expanded our clinical programs from 2 to 9 therapeutic areas,” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “Next year, Click will expand our library of validated DiNaMo interventions, run multiple registrational trials and real-world-evidence studies, and further partner with trusted biopharmaceutical companies who share in our vision to democratize access to best-in-class therapeutics for patients in need.”

About Click Therapeutics

Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for patients with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking 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 360 adults. Click is progressing a broad pipeline of Digital Therapeutics™ across a variety of high-burden therapeutic areas, including MDD, Schizophrenia, Migraine, Multiple Sclerosis, Chronic Pain, Atopic Dermatitis, Acute Coronary Syndrome, Obesity, Oncology and more. For more information on Click, visit ClickTherapeutics.com.

Investor Contact

Daniel Busby
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Jonni Mills
jmills@clicktherapeutics.com