Click Therapeutics has collected a groundbreaking green light from the FDA for the agency’s first prescription digital therapeutic aimed at preventing migraines.
Designed to be used alongside standard drug therapies, a randomized, sham-controlled trial of Click’s smartphone app showed it could significantly reduce an adult’s number of episodic migraine days per month.
According to the company, the FDA’s de novo clearance paves the way for future development of the program, dubbed CT-132, as a combined software-enhanced drug therapy.
“With this landmark, first-in-class FDA authorization in episodic migraine, Click’s interventions have now demonstrated clinically meaningful benefit across three unique therapeutic areas, including psychiatry, cardiometabolic disease and now neurology,” CEO David Benshoof Klein said in a statement.
Click received a clearance last year for a depression therapy app developed with the drugmaker Otsuka, and later acquired a diabetes-focused platform through its purchase of assets from the defunct digital treatment developer Better Therapeutics.
“As the first authorization in our neurology pipeline, and the first of our PDTs to target and successfully treat a pain-related condition, it confirms the power of Click’s platform to deliver meaningful outcomes across therapeutic areas,” Klein added.
The company announced last September that CT-132 met the primary endpoint of its pivotal study, cutting the number of migraine days by an additional three per month, following 12 weeks of treatment. Study participants also reported improvements in migraine-related quality of life and broader health questionnaires.
The program is designed to reduce brain hypersensitivity by modulating the patient’s responses to environmental and internal stimuli. A separate clinical study showed that CT-132 performed similarly in patients taking calcitonin gene-related peptide inhibitors, or CGRP medications for migraines, the company said.
Click announced last month that it raised an undisclosed sum through a series C funding round, backed entirely by Dassault Systemes and its Medidata Solutions division. The companies said the financing came paired with a development collaboration agreement.