Trial of Click's DTx for migraine sets up FDA filing

Click Therapeutics' digital therapeutic (DTx) for migraine has hit the mark in a late-stage study using an endpoint commonly used to test drug therapies, which it claims is a first for the prescription DTx category.

In the 568-patient ReMMi-D trial, CT-132 was compared to a sham app in the prevention of episodic migraine in adults and achieved a statistically significant reduction in monthly migraine days after 12 weeks of treatment.

The mobile app – which is intended for use on top of existing treatments for migraine – reduced the number of migraine days in a month by around three, roughly one day more than the control. To put that into context, episodic migraine is characterised by headaches that occur on fewer than 15 days per month. Above that level, patients are considered to have chronic migraine.

According to Click, CT-132 was also significantly better at improving quality of life measured using the MSQ scale from four weeks onwards in the study, as well as migraine disability scores (MIDAS) and patient-reported improvements in health status (PGIC) at 12 weeks.

Patients in ReMMi-D were taking the most commonly prescribed migraine medicines like triptans, and Click has also completed a second, smaller bridging study, called ReMMiD-C, which looked at patients on the newer class of CGRP inhibitors, which it said provided "supportive information."

Armed with the data, Click is now planning to seek FDA approval for the DTx, which has been awarded breakthrough device status by the regulator.

The company recently claimed FDA approval for the first description DTx for major depressive disorder (MDD) – Otsuka-partnered Rejoyn – and got another breakthrough designation for an app for schizophrenia partnered with Boehringer Ingelheim earlier this year.

Stewart Tepper of the New England Institute for Neurology and Headache said the design of the two studies is "similar to comparable preventive medication migraine trials" and makes CT-132 "the first migraine digital therapeutic to be studied with this degree of rigour."

If approved, 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," he added.

Unlike in drug studies, patients in ReMMi-D and ReMMiD-C continued their existing migraine medications without any washout period, so the additive treatment effect of CT-132 on top of background drug therapy could be evaluated.

Click said the data from the studies may also support the application of recent FDA guidance on Prescription Drug Use-Related Software (PDURS) that covers combining traditional drugs with software to enhance drug labels.

With that in mind, Click's chief strategy officer, Austin Speier, revealed that the firm is "actively investigating" offering a drug-digital combination therapy to patients that offers "a single, integrated experience for the patient, prescriber, and payer."

That could be significant, as some DTx developers have struggled to build a sustainable commercial business, in part because of uncertain reimbursement pathways in the US.

Last year, US lawmakers reintroduced the Access to Prescription Digital Therapeutics Act, which would create a dedicated benefit category for these products in Medicare and Medicaid, but that has not yet made it onto the statute.