Presently under development, the CT-132 digital therapeutic candidate has secured the FDA designation in patients of age 18 or more
FDA grants breakthrough device status for Click Therapeutics’ CT-132. (Credit: Gerd Altmann from Pixabay)
US-based Click Therapeutics has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its CT-132 prescription digital therapeutic candidate as an adjunctive preventive treatment for episodic migraine.
Presently under development, CT-132 has been given the designation in patients of age 18 or more.
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.”
According to the firm, the CT-132 candidate has been validated by the active support of its migraine advisory board.
By utilising and extending its proprietary Click Neurobehavioral Intervention (CNI) Platform, Click Therapeutics has finished or begun three clinical trials on CT-132.
When these trials are finished, the data from them will support the product’s submission to the FDA for regulatory review, the prescription medical treatments provider added.
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 FDA breakthrough devices programme is designed for products with the potential to treat life-threatening or permanently crippling conditions more effectively.
Click’s Therapeutics develops solutions to be used independently or in conjunction with biomedical treatments via cognitive and neurobehavioral mechanisms.
The company is also said to be developing a pipeline of digital therapeutics across various therapeutic areas like schizophrenia, major depressive disorder (MDD), migraine, chronic pain, multiple sclerosis (MS), atopic dermatitis, obesity, acute coronary syndrome, and oncology.
In October last year, the firm raised $52m in a Series B financing round to expand its prescription digital therapeutic pipeline and platform capabilities.