NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced meeting the primary endpoint in the pivotal randomized, double-blind, controlled, decentralized, study of CT-132 for the preventive treatment of migraine, ReMMi-D (Reduction in Monthly Migraine Days, NCT05853900).
At completion of the study, CT-132 showed a statistically significant reduction in monthly migraine days (MMDs) following 12 weeks of treatment compared to sham, (n=568, ITT population, -0.9 MMDs, p=0.005), with the treatment arm experiencing -3.04 MMDs by end of treatment. Further, CT-132 improved Migraine-Specific Quality-of-Life Questionnaire (MSQ) from as early as 4 weeks and through weeks 8 and 12 (p<0.001 at all time points), and the treatment group experienced categorical improvement in the Migraine Disability Assessment (MIDAS) at the end of treatment (p=0.002). Additionally, patients reported improvement in their health due to CT-132 as measured by the Patient Global Impression - Change (PGI-C) at the end of the trial (p<0.001). Engagement and adherence were high and sustained over the full 12-week duration of the treatment. Both the intervention and sham groups demonstrated nearly 100% median completion of daily tasks. CT-132 was well tolerated and exhibited no treatment-related adverse events. In addition, the recently completed ReMMiD-C bridging study (NCT06004388) provided supportive information to the pivotal study in patients taking the new-class of migraine-specific medications, CGRP inhibitors.
“This is a significant milestone for more than one billion people worldwide living with migraine. Click has developed and evaluated a first-in-class digital migraine preventive therapeutic, CT-132, in two separate clinical studies to demonstrate a reduction in monthly migraine days, the gold standard measure,” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “We look forward to advancing our FDA Breakthrough Designated asset through regulatory clearance and, if successful, offering a new therapeutic option that can be delivered to any eligible patient with a smartphone, meaningfully enhancing access to care.”
“The design and results of these studies, which are similar to comparable preventive medication migraine trials, support the clinical performance of CT-132,” said Stewart Tepper, MD, Vice President of the New England Institute for Neurology and Headache. “The clinical data demonstrate a successful reduction in monthly migraine days, which was the primary endpoint, as well as improving quality of life and reducing disability. This is the first migraine digital therapeutic to be studied with this degree of rigor, and the availability of CT-132 would be a very useful addition to our migraine armamentarium providing additional benefit to patients on migraine medication and expanding access to non-pharmacological treatment options.”
Migraine is a complex and debilitating condition that affects more than 37 million adults and is the second leading cause of disability in the United States.1,2 It is characterized by episodes of moderate-to-severe headache and is generally associated with nausea and increased sensitivity to light and sound.3 For those living with migraine, attacks unfold over hours to days and negatively impact key domains of life including employment, educational attainment and relationships.4 Despite the availability of preventive migraine medications, there remains a significant unmet need in migraine management. Many patients continue to experience frequent and debilitating attacks, even when using these drugs as prescribed.5
The device under investigation in the completed studies, CT-132, is a prescription digital therapeutic being developed by Click Therapeutics to address this unmet need. It is intended for the preventive treatment of episodic migraine in adults 18 years or older, for use alongside existing medications for migraine. The product delivers a proprietary 12-week clinical intervention aimed at reducing brain hypersensitivity implicated in migraine by modulating patient responses to environmental and internal stimuli to help restore patients' ability to engage fully in daily activities.
The efficacy and safety of CT-132 were evaluated in two Phase III trials for reducing the number of MMDs compared to sham in patients already using acute and preventive migraine medication. ReMMi-D included patients on the most commonly prescribed migraine medications, while the ReMMiD-C study bridged the pivotal with patients taking the new class of migraine-specific medications, CGRP inhibitors. The study designs mirrored those of contemporary randomized control trials for migraine drugs. However, unlike in drug studies, patients continued their existing migraine medications without any washout period, so the additive treatment effect of CT-132 on top of background pharmacotherapy could be evaluated.
“These clinical data provide information not only on benefit to patients, but importantly added clinical benefit of software plus drug compared to drug alone. This opens the door to applying recent FDA guidance on Prescription Drug Use-Related Software (PDURS) that addresses combining traditional drugs with software to enhance drug labels. As such, in addition to pursuing regulatory clearance for CT-132, we are actively investigating offering a drug-digital combination therapy to patients, one with added clinical benefit data that offers a single, integrated experience for the patient, prescriber and payer,” said Austin C. Speier, Chief Strategy Officer of Click Therapeutics. “These results also further validate Click’s unique approach to digital therapeutic development, benefiting from intensive patient co-creation and our AI-enabled platform, which has now supported the development of multiple prescription digital therapeutics. We look forward to the further development of our pipeline of assets, whether standalone or in combination with drugs, as we continue our mission to address unmet patient needs with software as treatments.”
Click is committed and looking forward to sharing study findings through presentations at major medical conferences and publications in peer-reviewed journals.
About CT-132
CT-132 is an investigational prescription digital therapeutic intended for the preventive treatment of episodic migraine in adults 18 years of age and older. It is intended for adjunctive use alongside other treatments for migraine. CT-132 is an investigational device and is not currently available for sale in the United States. Its safety and effectiveness have not yet been evaluated by FDA.
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™, we deliver accessible, clinically validated, FDA-regulated prescription treatments to the smartphone in your hand. Our treatments are defined by our 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. We are continuously expanding and refining our shared platform technologies with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning.
Click Therapeutics, in collaboration with Otsuka, developed the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms, Rejoyn™. 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 the best place to work, we foster an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in our 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.
References
1 . American Migraine Foundation https://americanmigrainefoundation.org/resource-library/migraine-facts/
2 . Steiner TJ, et al. J Headache Pain. 2020;21(1):137. https://pubmed.ncbi.nlm.nih.gov/33267788/
3 . National Institute of Neurological Disorders and Stroke https://www.ninds.nih.gov/health-information/disorders/migraine
4. Buse, D. C., Fanning, K. M., Reed, M. L., Murray, S., Dumas, P. K., Adams, A. M., & Lipton, R. B. (2019). Life With Migraine: Effects on Relationships, Career, and Finances From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache, 59(8), 1286–1299. https://doi.org/10.1111/head.13613
5. Bentivegna, E., Onan, D., & Martelletti, P. (2023). Unmet Needs in Preventive Treatment of Migraine. Neurology and therapy, 12(2), 337–342. https://doi.org/10.1007/s40120-023-00438-z
