Click Therapeutics has secured Breakthrough Device Designation for its CT-132 prescription digital therapeutic to treat episodic migraine, from the US Food and Drug Administration (FDA).
CT-132 is currently under development as an adjunctive preventive treatment for episodic migraine in people of age 18 years and above.
It has been designed for reducing the number of migraines that occur per month in patients suffering with four or more migraine days per month.
CT-132 combines the company’s adaptive patient engagement platform with multiple clinically validated mechanisms of action.
Click Therapeutics chief strategy officer Austin Speier said: “We are thrilled to receive this Breakthrough designation as it will facilitate collaborative discussions with the FDA and help expedite the process of bringing a first-in-class migraine digital therapeutic to patients.
“This is also powerful recognition of the innovative work led by our in-house science and development teams to create a new approach to treating migraine, one supported by early, promising clinical data.”
The company stated that the CT-132 programme is authorised by the active support of its Migraine Advisory Board.
Using and extending its patented Click Neurobehavioral Intervention (CNI) Platform, Click has finished or started three clinical trials on CT-132.
Upon completion, the data will support the product’s regulatory submission to the FDA.
Click Therapeutics chief medical officer Shaheen Lakhan said: “Breakthrough further affirms that our unique approach to unlock undruggable CNS targets has merit through the combination of digital neuroactivation and modulation (DiNaMo) and neurobehavioral interventions.
“Through this new paradigm, we aim to restore lives ravaged by debilitating brain diseases like migraine.”
The company develops, validates, and commercialises software as prescription medical treatments for people suffering with unmet medical requirements.