Click Therapeutics and Boehringer Ingelheim Announce FDA Breakthrough Device Designation for Prescription Digital Therapeutic to Treat Negative Symptoms of Schizophrenia

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.

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.

For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn.

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 boehringer-ingelheim.com/us/

Investor Contacts
Daniel Busby
ir@clicktherapeutics.com

Media Contacts
Jonni Mills
pr@clicktherapeutics.com

Susan Holz
susan.holz@boehringer-ingelheim.com

References

1 . National Institute of Mental Health. (May 2018). Schizophrenia Statistics [Website]. https://www.nimh.nih.gov/health/statistics/schizophrenia.shtml#part_15488 Accessed July 20, 2020.
2 . “Schizophrenia.” World Health Organization, World Health Organization, https://www.who.int/news-room/fact-sheets/detail/schizophrenia.
3 . National Institute of Mental Health. (May 2020). Schizophrenia [Website]. https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml Accessed July 20, 2020.
4 . Christensen MK, Lim CCW, Saha S, et al. The cost of mental disorders: a systematic review. Epidemiol Psychiatr Sci. 2020;29:e161.
5 . Milev P, Ho BC, Arndt S, Andreasen NC. Predictive values of neurocognition and negative symptoms on functional outcome in schizophrenia: a longitudinal first-episode study with 7-year follow-up. Am J Psychiatry. 2005 Mar;162(3):495-506. doi: 10.1176/appi.ajp.162.3.495. PMID: 15741466.
6 . Christoph U Correll & Nina R Schooler (2020) Negative Symptoms in Schizophrenia: A Review and Clinical Guide for Recognition, Assessment, and Treatment, Neuropsychiatric Disease and Treatment, 16:, 519-534, DOI: 10.2147/NDT.S225643
7 . Kirkpatrick B, Fenton WS, Carpenter WT Jr, Marder SR. The NIMH-MATRICS consensus statement on negative symptoms. Schizophr Bull. 2006 Apr;32(2):214-9. doi: 10.1093/schbul/sbj053. Epub 2006 Feb 15. PMID: 16481659; PMCID: PMC2632223.