Boehringer Ingelheim and Click Therapeutics receive FDA breakthrough device designation for schizophrenia prescription digital therapeutic

• The evidence-based PDT provides psychosocial intervention techniques to people experiencing negative symptoms of schizophrenia. 
• Negative symptoms affect mood, motivation, interactions with people and can include emotional withdrawal and lack of pleasure.  
• 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.  

Why it matters

• People experiencing negative symptoms of schizophrenia often lack consistent and easily accessible therapy that specifically addresses those symptoms and can be socially isolated or disconnected from everyday life.  
• 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 
• If approved, CT-155 may offer an easily accessible, clinically validated mobile medical intervention that digitizes behavioral therapy and accompanies the person day-to-day.  

Christine Sakdalan, US Head, Mental Health franchise, Boehringer Ingelheim: 

“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.”  

Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics: 

“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.” 

Boehringer Ingelheim and Click Therapeutics

By combining Click Therapeutics' proficiency in creating effective digital therapeutics with Boehringer Ingelheim's clinical development expertise, the collaboration aims to provide innovative solutions for patients with neuropsychiatric diseases, particularly schizophrenia. The partnership is developing a prescription-based digital therapeutic, CT-155, which is designed to help schizophrenia patients achieve positive clinical outcomes. This application combines multiple clinically validated therapeutic interventions, aiming to reduce cognitive deficits and improve social functioning. The collaboration is committed to addressing the significant unmet need in schizophrenia treatment, where access to psychosocial intervention therapies is often limited. The partnership also provides an opportunity for both companies to further establish digital therapeutics as a meaningful new treatment category for patients and providers, potentially revolutionizing the way neuropsychiatric disorders are treated.

About Boehringer Ingelheim

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 www.boehringer-ingelheim.com.  

About Click Therapeutics

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click’s treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral, and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, cardiology, and immunology. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers, and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics.  

References

¹National Institute of Mental Health. Schizophrenia Statistics [Website]. Schizophrenia - National Institute of Mental Health (NIMH) (nih.gov) Accessed December 23, 2023.   

²Schizophrenia.” World Health Organization, World Health Organization, https://www.who.int/news-room/fact-sheets/detail/schizophrenia. 

³National Institute of Mental Health. (May 2020). Schizophrenia [Website]. https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml, Accessed January  2, 2024. 

⁴Christensen MK, Lim CCW, Saha S, et al. The cost of mental disorders: a systematic review. Epidemiol Psychiatr Sci. 2020;29:e161. 

Contact Click Therapeutics: 

Jonni Mills 
pr@clicktherapeutics.com