Click Therapeutics and Boehringer Ingelheim Initiate Pivotal Clinical Trial of Prescription Digital Therapeutics for the Treatment of Negative Symptoms in Schizophrenia

• The primary objective of the CONVOKE study is to evaluate the efficacy of prescription digital therapeutics (PDTs) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in patients 18 years and older.

• This study represents the continuation of shared efforts between Boehringer Ingelheim and Click Therapeutics to provide additional treatment options for patients with schizophrenia.

• The companies have developed a unique therapeutic approach utilizing digital mechanisms of action to create a potential first-in-class treatment for the negative symptoms of schizophrenia.

NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced the initiation of the CONVOKE Study, a registrational clinical trial to investigate the use of prescription digital therapeutics as an adjunct treatment to standard of care antipsychotic therapy to treat the negative symptoms of schizophrenia in patients 18 years and older. The pivotal, randomized, multi-site trial will enroll approximately 432 patients nationwide. The study intervention period will be 16 weeks and efficacy will be assessed by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure scale (CAINS-MAP). The CAINS-MAP measures experiential negative symptoms, the clinical target of interest in the evaluation of efficacy in this study. The CAINS was developed and validated with National Institute of Mental Health (NIMH) funding in response to the limitations of existing treatment and assessment approaches to negative symptoms identified at the NIMH-MATRICS Consensus conference in 2005.¹

"Enrolling the first patient in this schizophrenia registrational trial marks a significant step forward in our mission to develop innovative therapies for patients suffering from serious mental illnesses,” said Han Chiu, Chief Technology Officer of Click Therapeutics. “Together with Boehringer Ingelheim, we are excited about advancing this program and improving outcomes for patients in need."

“Our partnership with Click Therapeutics, who share a like-minded goal through our approach to prescription digital therapeutics, has the potential to address significant unmet needs in schizophrenia. This first-in-class study brings us closer to realizing our approach of offering personalized care in mental health, from initial diagnosis through ongoing disease management to long-term support,” said Vikas Mohan Sharma, M.D., Therapeutic Area Head Medicine for CNS, Retinal Health and Emerging Areas at Boehringer Ingelheim.

Schizophrenia is a pervasive, chronic mental disorder affecting 24 million people, or 1 in 300 people worldwide.² Schizophrenia is characterized by disturbances in thought, perception and behavior and is one of the top 15 causes of disability worldwide, leading to a 2-3 times increased risk of premature mortality.³ Symptoms of schizophrenia typically emerge between the mid-teens and mid-thirties and the onset tends to occur earlier in men compared to women.⁴

Currently available antipsychotic medications for schizophrenia largely work to relieve certain positive symptoms, such as hallucinations, disorganized speech, and behavior agitation. However, a significant contributor to the profound burden associated with schizophrenia are negative symptoms, which are strong predictors of functional impairment⁵ and are not effectively addressed by standard of care antipsychotic or any other medication.^6,1 Thus, there is great promise in the development of prescription digital therapeutics to alleviate negative symptoms, offering healthcare providers and patients a means to tackle this severe mental illness, with the potential to significantly reduce the personal and socio-economic burden of schizophrenia. Currently, no approved pharmacotherapies or medical devices are available to treat the persistent negative symptoms of schizophrenia that are at the root of significant day-to-day functional impairment for these patients.

“Click and our partner, Boehringer Ingelheim, are not afraid to tackle disease of high unmet need that are not adequately addressed by current treatments, such as those implicated in the negative symptoms of schizophrenia. The CONVOKE study not only advances precision psychiatry by marrying personalized digital interventions with standard of care psychopharmacology, but also aims to help solve this key cause of disability for the millions living with schizophrenia,” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics.

About the Boehringer Ingelheim and Click Therapeutics Collaboration

In September 2020, Click and Boehringer Ingelheim announced a worldwide collaboration to develop and commercialize prescription digital therapeutics to aid in the treatment of schizophrenia. In December 2022, Click and Boehringer Ingelheim announced the expansion of this partnership to address additional unmet needs for patients with schizophrenia.

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™, we deliver accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Our treatments are defined by our 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. We are continuously expanding and refining our shared platform technologies with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. Digital therapeutics under development on our platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, cardiology and immunology. Consistently named a best place to work, we foster an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in our 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 improve the lives of humans and animals. 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 perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.com.

References

1 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.

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

3 “Schizophrenia.” National Institute of Mental Health, U.S. Department of Health and Human Services, https://www.nimh.nih.gov/health/statistics/schizophrenia.

4 Gogtay N, Vyas NS, Testa R, Wood SJ, Pantelis C. Age of onset of schizophrenia: perspectives from structural neuroimaging studies. Schizophr Bull. 2011 May;37(3):504-13. doi: 10.1093/schbul/sbr030. PMID: 21505117; PMCID: PMC3080674.

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

Investor

Daniel Busby
ir@clicktherapeutics.com

Media

Jonni Mills
pr@clicktherapeutics.com

Susan Holz
susan.holz@boehringer-ingelheim.com