Click Therapeutics Announces Multiple Publications Supporting Its Digital Therapeutic for Major Depressive Disorder; Seeking FDA Clearance

The results of a 51-person randomized controlled trial of the Emotional Faces Memory Task (EFMT), a digital therapeutic for MDD, were recently published in npj Digital Medicine, a Nature research journal. This trial found EFMT to be superior to the control group in terms of MDD symptom reduction, and also the proportion of participants meeting “clinical responder” criteria (≥ 50% improvement). EFMT was co-developed by Dennis S. Charney, M.D., Anne and Joel Ehrenkranz Dean and Professor of Psychiatry, Neuroscience, and Pharmacological Sciences at the Icahn School of Medicine at Mount Sinai (ISMMS), and Brian Iacoviello, Ph.D., Director of Scientific Affairs at Click Therapeutics and Assistant Professor of Psychiatry at ISMMS.

Dr. Charney, a world expert in the neurobiology and treatment of mood and anxiety disorders, notes, “This is a significant step in validating the effectiveness of this treatment. The data is very encouraging and could offer hope to many sufferers of this debilitating disease. EFMT has moved quickly from concept into a patient-ready treatment due in part to the unique collaborations with Click Therapeutics.”

A brain imaging study of the effects of EFMT on key brain regions involved in MDD was presented at the Society of Biological Psychiatry Annual Scientific Convention in New York, NY in May 2018. In this study, patients showed a post-treatment increase in effective connectivity between cognitive control and emotion processing brain regions, which was also associated with the degree of MDD symptom improvement observed in these patients; a striking finding indicating a direct link between the digital therapeutic and a neurobiological mechanism.

Sophia Frangou, M.D., Professor of Psychiatry at ISMMS, founding chair of the EPA Section of NeuroImaging and of the Brain Imaging Network of the European College of Neuropsychopharmacology, and senior collaborator on this study, describes these findings as “initial evidence that cognitive-emotional training may be associated with changes in brain plasticity in the networks implicated in MDD,” and notes, “This helps us understand how EFMT has its effect in patients with MDD.”

Additionally, a pilot trial of combined EFMT + transcranial direct current stimulation (tDCS) in 20 patients with treatment-resistant depression has been published in the Journal of Affective Disorders. In this study, the EFMT + tDCS combination was found to be feasible, safe, and associated with significant antidepressant efficacy. The study was completed in collaboration between ISMMS and the University of New South Wales (UNSW) in Australia.

Colleen Loo, M.D., Professor of Psychiatry at UNSW, remarks, “This study provides preliminary evidence that tDCS combined with cognitive-emotional training has great potential as a novel method for optimizing the antidepressant efficacy of tDCS in medication resistant depression patients, which is sorely needed for this difficult-to-treat population.”

Dr. Iacoviello comments, “The data from these studies combined are incredibly encouraging for EFMT as an effective treatment for MDD. Not only do we observe symptom improvement in adults with MDD, and adults with medication resistant depression when combined with tDCS, but for the first time we have shown that EFMT can have the neuroplastic effects expected in key brain regions involved in MDD, and that these changes are associated with symptom improvement.”

David Benshoof Klein, CEO of Click Therapeutics, remarks, “Approximately 70% of depressed patients would prefer a non-pharmacological treatment, and a sizeable proportion currently go under-treated. We look forward to bringing our software to market as a prescription medical treatment for depression to help address this unmet need. Click has met with FDA to confirm the regulatory and clinical pathway, and will seek clearance as a class II medical device with a treatment claim following a pivotal study that will commence shortly. In addition, we are collaborating with our strategic investor, Magellan Health, on this effort. Our high quality data combined with Magellan’s expertise in clinical impact, behavioral health and reimbursement will help ensure that the program is available to those patients in need upon clearance from FDA.”

Copies of the above referenced publications can be viewed via npj Digital Medicine at https://www.nature.com/articles/s41746-018-0025-5, the Click Therapeutics website at http://clicktherapeutics.com/publications/hoch-2018-society-of-biological-psychiatry.pdf, and via Journal of Affective Disorders at https://doi.org/10.1016/j.jad.2018.02.021.

About Click Therapeutics

Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program is entering into a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults. For more information, visit ClickTherapeutics.com.

About Magellan Health: Magellan Health, Inc. is a leader in managing the fastest growing, most complex areas of health, including special populations, complete pharmacy benefits and other specialty areas of healthcare. Magellan supports innovative ways of accessing better health through technology, while remaining focused on the critical personal relationships that are necessary to achieve a healthy, vibrant life. Magellan’s customers include health plans and other managed care organizations, employers, labor unions, various military and governmental agencies and third-party administrators. For more information, visit MagellanHealth.com.

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