Click’s DTx Migraine Test Prepares FDA Submission

Click Therapeutics’ digital therapy (DTx) for migraine has achieved success in a late-stage trial using an endpoint commonly used to test drug therapies, a first for prescription DTx, the company says.

The ReMMi-D study of 568 patients compared CT-132 with sham therapy for the prevention of episodic migraine in adults. A statistically significant reduction in the number of migraine days per month was achieved after 12 weeks of treatment.

The mobile app—designed to be used in conjunction with existing migraine treatments—reduced the number of migraine days per month by about three, or about one more day than the control group. To put that in context, episodic migraine is characterized by headaches occurring less than 15 days per month. Above that level, patients are considered to have chronic migraine.

According to Click, CT-132 was also significantly more effective in improving quality of life as measured by the MSQ scale from the fourth week of the study, as well as in Migraine-related Disability Assessment (MIDAS) and Patient-Reported Health Improvement (PGIC) scores at 12 weeks.

Patients in the ReMMi-D study were taking the most commonly prescribed migraine medications, such as triptans, and Click also completed a second, smaller bridging study, called ReMMiD-C, that included patients taking a newer class of CGRP inhibitors, which were said to provide “supportive information.”

Armed with the data, Click now plans to seek FDA approval for the DTx device, which the regulator has granted breakthrough device status.

The company recently filed for FDA approval of the first DTx description for major depressive disorder (MDD) – Rejoyn, a partnership with Otsuka – and received another breakthrough designation for an application for schizophrenia, a partnership with Boehringer Ingelheim earlier this year.

Stewart Tepper of the New England Institute for Neurology and Headache said the design of both studies “is similar to comparable studies of preventive migraine medications” and makes CT-132 “the first digital migraine drug to be studied with this degree of rigor.”

If approved, CT-132 would be “a very useful addition to our migraine arsenal, providing additional benefits to patients taking migraine medications and expanding access to non-pharmacological treatment options,” he added.

Unlike studies conducted in drug trials, patients in ReMMi-D and ReMMiD-C continued to take their current migraine medications without a washout period, allowing for an assessment of the additive effect of CT-132 treatment with pharmacological therapy as part of therapy.

Click said the study data may also support the use of the FDA’s latest guidance on prescription drug reconnaissance software (PDURS), which includes combining traditional medicines with software to improve drug labels.

With that in mind, Click’s chief strategy officer, Austin Speier, revealed that the company is “actively exploring” the possibility of offering patients a combined drug-digital therapy that offers “a single, integrated experience for the patient, prescriber, and payer.”

This could be important because some DTx developers have struggled to build a sustainable commercial business, in part because of uncertain paths to reimbursement in the U.S.

Last year, U.S. lawmakers reintroduced Digital Prescription Medicines Access Actwhich would create a separate benefit category for these products under the Medicare and Medicaid programs, but that proposal has not yet been included in the bill.