NEW YORK – May 4, 2023 – 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.

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.

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 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.