Click Therapeutics Launches Additional Randomized Clinical Study in Migraine, Conducted in Partnership with Syneos Health

• The study marks Click’s second active randomized clinical trial testing digital interventions in migraine patients.
• The ReMMiD-C trial will evaluate the efficacy and safety of investigational digital therapeutics for the prevention of episodic migraine in patients 18 years and older receiving Calcitonin Gene-Related Peptide (CGRP) inhibitor therapy.
• Click and Syneos Health have developed a unique approach utilizing digital, decentralized clinical trial solutions to execute the study.

NEW YORK – August 02, 2023 – Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, , today announced the launch of its second active randomized clinical trial in migraine, ReMMiD-C, Reduction in Monthly Migraine Days-CGRP study, a fully remote and decentralized trial designed to investigate the efficacy and safety of digital therapeutics in reducing the number of monthly migraine days for adults diagnosed with episodic migraine currently receiving Calcitonin-Gene-Related Peptide (CGRP) inhibitor therapy. Click also recently launched the ReMMi-D study, a phase 3 pivotal registration study in approximately 558 patients, in March (NCT05853900). To execute this latest fully remote trial, Click has selected Syneos Health® (Nasdaq:SYNH), a leading fully integrated biopharmaceutical solutions organization.

Together, Click and Syneos Health are designing and deploying the study, enabling patients to consent, enroll, and receive treatment remotely. The combination of Click’s digital therapeutics delivered as mobile applications and Syneos Health Decentralized Solutions delivers innovative trial design expertise to accelerate patient access, enabling patients to participate in the trial anywhere, at any time, using their own devices. This modern approach reflects the real-world potential impact and accessibility of prescription digital therapeutics

“We are thrilled to join forces with Syneos Health to realize Click's visionary mission to increase access to evidence-backed therapies. Together, we are committed to pushing the boundaries of inclusivity and equity, ensuring that every individual, regardless of background or circumstance, is given a fair opportunity to participate in cutting-edge research. This groundbreaking decentralized study represents a significant step forward, empowering migraineurs who have been traditionally overlooked by clinical trials," said Shaheen Lakhan MD, PhD, FAAN, Chief Medical Officer, Click Therapeutics.

Click Therapeutics received Breakthrough Device Designation (BTDD) from FDA for its migraine program in December 2022. Migraine is a complex and debilitating condition that affects more than 40 million adults, ^{1, 2} and is the second leading cause of disability in the United States.³ Migraine is characterized by episodes of moderate-to-severe headache and generally associated with nausea and increased sensitivity to light and sound.⁴ Its burden is impacted by employment status, poverty, education attainment and insurance coverage. Although there are a variety of pharmacologic and nonpharmacologic acute and preventative treatments available, they are not without notable limitations, and patients often do not achieve full remission in response to pharmacotherapy alone. A prescription digital therapeutic can help migraine patients access treatment, as well as give additional tools to providers treating migraine patients.

“In today’s rapidly evolving clinical trial landscape, it’s imperative to design studies through the lens of accelerating patient access, improving retention and increasing diversity,” said Michael Brooks, Chief Operating Officer, Syneos Health. “We’re excited to be working with Click Therapeutics on this fully remote trial – showcasing our ability to combine fully integrated clinical, RWE and commercial insights, agile technologies and operational excellence to bring clinical trials closer to the patient. These trials maintain the same rigor as traditional clinical trials and fully support evidence generation for regulators and payers.”

The phase 3, randomized, double-blind trial will enroll approximately 100 patients in the United States. Trial intervention will be delivered over 12 weeks and efficacy will be evaluated between groups as a change from baseline in the number of monthly migraine days (MDDs). The study will provide bridging data to evaluate the effectiveness of digital therapeutics for migraine in patients receiving CGRP inhibitor therapy, an emerging class of third line preventive medication for migraine such as Aimovig, Emgality, and Nurtec, as 50% of patients do not see the relief they expect from these interventions.⁵This study will complement the clinical data from ReMMi-D in patients treated with first and second line preventive medications.

About Click Therapeutics
Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click’s treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn.

About Syneos Health
Syneos Health® (Nasdaq:SYNH) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.

Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.

To learn more about how we are Shortening the distance from lab to life®, visit syneoshealth.com or subscribe to our podcast.

Investor Contact

Daniel Busby
ir@clicktherapeutics.com

Media Contact

Jonni Mills
pr@clicktherapeutics.com

References

1. Stovner, L. J. & GBD 2016 Headache Collaborators. (2018). Global, regional, and national burden of migraine and tension-type headache, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurology, 17(11), 954–976. https://doi.org/10.1016/S1474-4422(18)30322-3
2. James, S. L., Abate, D., Abate, K. H., Abay, S. M., Abbafati, C., Abbasi, N., … & Murray, C. J. L. (2018). Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: A systematic analysis for the Global Burden of Disease Study 2017. Lancet, 392(10159), 1789–1858. https://doi.org/10.1016/s0140-6736(18)32279-7
3. Burch, R., Rizzoli, P., & Loder, E. (2018). The prevalence and impact of migraine and severe headache in the United States: Figures and trends from government health studies. Headache, 58, 496–505. https://doi.org/10.1111/head.1328
4. Torres-Ferrús, M., Ursitti, F., Alpuente, A., Brunello, F., Chiappino, D., de Vries, T., … & Lampl, C. (2020). From transformation to chronification of migraine: Pathophysiological and clinical aspects. J Headache Pain, 21, 42. https://doi.org/10.1186/s10194-020-01111-8
5. Edvinsson, Lars, et al. "CGRP as the target of new migraine therapies—successful translation from bench to clinic." Nature Reviews Neurology 14.6 (2018): 338-350.