Click Therapeutics announced today that it received FDA breakthrough device designation for its CT-132 prescription digital therapeutic (PDT).
New York-based Click designed CT-132 as an adjunctive preventive treatment for episodic migraine in patients 18 years old and up.
“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,” said Austin Speier, chief strategy officer of Click Therapeutics. “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.”
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The company develops and commercializes software as prescription medical treatments. It aims to treat major depressive disorder, schizophrenia, migraine, MS, chronic pain, atopic dermatitis, acute coronary syndrome, obesity and oncology.
Click’s technology uses cognitive and neurobehavioral mechanisms designed for use independently or in conjunction with biomedical treatments. Its Clickometrics adaptive data science platform continuously personalizes user experience. This optimizes engagement and outcomes, the company said.
Click’s CT-132 uses the proprietary Click Neurobehavioral Intervention (CNI) platform. The company completed or initiated three clinical trials on CT-132, leveraging and expanding the CNI platform. When complete, it plans to use data from the trials to support FDA submission.
Additionally, Click’s migraine advisory board validated the CT-132 program through its active support. It features leaders in headache research and clinical care chaired by Dr. Stewart Tepper. Tepper serves as professor of neurology at the Geisel School of Medicine at Dartmouth and director of Dartmouth Headache Center.
“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,” said Dr. Shaheen Lakhan CMO of Click Therapeutics. “Through this new paradigm, we aim to restore lives ravaged by debilitating brain diseases like migraine.”