NEW YORK – January 4, 2024 – Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that the investigational CT-155 prescription digital therapeutic (PDT), co-developed by Boehringer Ingelheim and Click Therapeutics, has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). CT-155 is a novel software accessible on mobile devices that is being studied for use adjunctive to standard of care pharmaceutical therapy and is designed to treat the negative symptoms of schizophrenia. It is one of multiple digital therapeutics under joint-development by the companies for the treatment of schizophrenia.

The Breakthrough Devices Program is intended for devices that have the potential to provide more effective treatment over the existing standard of care for life-threatening or irreversibly debilitating diseases. The program is designed to expedite the development and review of medical devices meeting Breakthrough Device criteria in the United States.

“We are thrilled to receive this Breakthrough Device designation for CT-155 as it brings us one step closer to being able to provide additional treatment options to those living with schizophrenia, where there remains a significant unmet need due to a lack of access to psychosocial intervention therapies,” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “Our unique therapeutic approach is on track to be the industry’s first-in-class treatment for the negative symptoms of schizophrenia.”

Schizophrenia is one of the 15 leading causes of disability worldwide, which impacts around 24 million people today.^1,2 It is a serious mental health condition that alters a person’s perception of reality and impacts how they think, feel, and behave.³ Schizophrenia is also associated with the highest worldwide societal cost per patient of all mental health disorders.⁴

Currently, available antipsychotic medications for schizophrenia are indicated for positive symptoms, such as hallucinations, disorganized speech, and behavior agitation. However, a significant contributor to the profound burden associated with schizophrenia is negative symptoms, which are strong predictors of cognitive impairment⁵ and are not effectively addressed by the standard of care antipsychotic or any other medication.^6,7 Thus, there is great promise in the development of PDTs to alleviate negative symptoms, offering healthcare providers and patients a means to tackle this severe mental illness. PDTs also have the potential to reduce the personal and socio-economic burden of schizophrenia. Currently, no approved pharmacotherapies or medical devices are available to treat the negative symptoms of schizophrenia that are at the root of significant day-to-day functional impairment for these patients.

“This Breakthrough Device designation is an affirmation of the groundbreaking work by the Boehringer Ingelheim and Click Therapeutics teams to advance the standard of care in schizophrenia. Prescription digital therapeutics, like CT-155, represent the future of medicine. This designation brings us one step closer to that reality by enhancing our ability to work with the FDA on market authorization and accelerate access to this future treatment option,” said Austin Speier, Chief Strategy Officer of Click Therapeutics.

To date, the CT-155 program has achieved all development milestones and generated supportive data across multiple clinical learning studies, leading to the initiation of the CONVOKE registrational clinical trial, in May 2023.

CT-155 is the first investigational PDT developed as part of the collaboration between Click Therapeutics and Boehringer Ingelheim, which has been in effect since September 2020. The collaboration has since expanded to include an additional investigational prescription-based digital therapeutic for use alone and in combination with pharmaceutical therapy to help people with schizophrenia achieve positive clinical outcomes, which was announced in December 2022.

“The FDA Breakthrough Device designation is an important milestone towards our goal of addressing the unmet medical needs in mental health and providing an innovative, future treatment option to enable people with schizophrenia to thrive,” said Christine Sakdalan, US Head, Mental Health franchise.

Click Therapeutics, Inc. develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. We are expanding the possibilities of medicine with Digital Therapeutics™ that combine clinical science with the power of software to create a new way to treat disease.  

Operating at the intersection of biology and technology, we use a proprietary platform-based approach to therapeutic development that leverages patient-centric design principles and innovative AI-based technologies to deliver a unique combination of engagement and clinical outcomes, consistently. Digital therapeutics on Click’s platform are regulated, clinically validated prescription mobile applications that can address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. 

Click Therapeutics, in collaboration with Otsuka, developed the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms, Rejoyn™. In October 2024, in response to FDA guidance on prescription drug use-related software (PDURS), we launched Click SE™ to extend our digital therapeutics platform and expertise to the development of software-enhanced drug™ therapies that combine software with pharmacotherapy to offer added clinically meaningful benefit to patients.

Our commitment to advancing digital medicine means we continually improve our platform technologies, ensuring we stay at the forefront of cognitive, behavioral, and neuromodulatory therapeutic innovation, to achieve the best possible outcomes for patients. Our diverse team of innovators—spanning clinicians, researchers, technologists, designers and more—works together to create cutting-edge digital therapeutics, united in the mission to transform patient care. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn.

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at boehringer-ingelheim.com/us/