Boehringer and Click Therapeutics’ Investigational Prescription Digital Therapeutic CT-155 Meets Primary Endpoint in CONVOKE Study for Negative Symptoms in Schizophrenia

In the CONVOKE study, CT-155 was well tolerated and demonstrated a favorable safety profile consistent with past studies.

“Today’s positive results from the CT-155 pivotal trial are an important moment for people living with the negative symptoms of schizophrenia,” said Emmanuelle Clerisme-Beaty, Medical Director US, SVP Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.. “Although treatments are being used to help manage negative symptoms, there are no U.S. regulatory authority-approved treatments indicated for the negative symptoms of schizophrenia to date. This is one of the largest unmet needs for these patients and those who care for them. We are proud to work in partnership with multiple stakeholders and innovative partners like Click Therapeutics on this journey.”

Approximately 2.8 million adults in the U.S. live with schizophrenia, which places a profound burden on individuals, families and society.^4,5 About 60% of people living with schizophrenia experience negative symptoms.³

“Findings from CONVOKE provide the first Phase III evidence supporting the potential of a prescription digital therapeutic as an adjunct to standard of care antipsychotic therapy to treat a core element of schizophrenia,” said Shaheen Lakhan, MD, PhD, FAAN, chief medical and scientific officer of Click Therapeutics. “The observed clinical benefit on experiential negative symptoms in this study, without additional known safety concerns, marks a critical advancement in understanding how we might address this long unmet need.”

Detailed results will be presented during the Novel Therapeutics Symposium on Monday, October 13 at the 38^th Annual European College of Neuropsychopharmacology (ECNP) Congress being held in Amsterdam, The Netherlands.

About CT-155

CT-155 (BI 3972080) is an investigational prescription digital therapeutic that aims to provide interactive psychosocial intervention techniques as an adjunct to standard antipsychotic therapy to people living with schizophrenia experiencing negative symptoms.^1,2,6 CT-155 is being developed by Click Therapeutics, Inc. and Boehringer Ingelheim.^1,6

In 2024, CT-155 was granted Breakthrough Device designation by regulatory authorities in the U.S.⁶

CT-155 has not been authorized by any regulatory authorities. Safety and effectiveness have not been established by any regulatory authority.

About the CONVOKE study

CONVOKE (NCT05838625) was a Phase III, multicenter, randomized, double-blind, 16-week study evaluating the efficacy and safety of CT-155 versus a digital control app as an adjunct to standard of care antipsychotic therapy in people diagnosed and living with schizophrenia and experiential negative symptoms.¹ The study enrolled adults and late adolescents with schizophrenia who were stable on antipsychotic medication.¹

The primary endpoint evaluated improvement in experiential negative symptoms as an adjunct to standard of care as measured by changes from baseline to week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).¹

Other endpoints include: change from baseline in CAINS-MAP at week 8; change from baseline in CAINS expressivity scale (CAINS-EXP) at weeks 8 and 16; change from baseline in positive symptoms measured by the Positive and Negative Syndrome Scale (PANSS) at weeks 8 and 16; change from baseline in social functioning measured by the Personal and Social Performance Scale (PSP) at weeks 8 and 16; and patient global impression of improvement measured by Patient Global Impression of Improvement Scale (PGI-I) at weeks 8 and 16.¹

About prescription digital therapeutics (PDTs)

PDTs are software-based interventions prescribed by healthcare professionals and installed on smartphones to help address behavioral dimensions of diseases and conditions.^7,8 PDTs are designed to be convenient, user friendly and accessible at all times of day, potentially helping to address barriers to care such as costs and mental health provider shortages—a shortage that is particularly exacerbated in rural areas.^7,8,9,10 Additionally, the care provided can be patient-centered and flexible, to meet the patient where they are in their own treatment journey.^7,8

About negative symptoms of schizophrenia

Schizophrenia affects approximately 24 million people worldwide, and about 60% of people living with the condition experience negative symptoms.^3,4 Negative symptoms are one of the three core symptoms domains of schizophrenia, along with positive symptoms and cognitive impairment.¹¹ Negative symptoms include both experiential or expressive symptoms.^3,12 Experiential negative symptoms include lack of motivation (avolition), decreased social interactions (asociality) and diminished ability to feel pleasure (anhedonia).^3,12 Expressive negative symptoms refer to decreased expression of emotions (blunted affect) and reduction in speaking (alogia).^3,12

In a U.S. single retrospective analysis, schizophrenia was associated with a significant economic burden, accounting for over $60 billion in direct healthcare costs in 2019.¹³ In another U.S. retrospective cohort study assessing claims from 2016-2023, the economic burden was greater for those who experience negative symptoms than those without negative symptoms, as these symptoms were associated with higher healthcare resource utilization, including higher costs, more outpatient/inpatient visits and longer hospitalizations.¹⁴

Although treatments are being used to help manage negative symptoms, there are no U.S. regulatory authority-approved treatments indicated for negative symptoms of schizophrenia to date.^3,6

About Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at boehringer-ingelheim.com.

About Click Therapeutics

Click Therapeutics, Inc. develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. Operating at the intersection of biology and technology, Click uses 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. Digital therapeutics on Click’s platform are regulated, clinically validated prescription mobile applications that are being developed to address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases.

Click’s commitment to advancing digital medicine means they continually improve their platform technologies, ensuring they stay at the forefront of cognitive, behavioral, and neuromodulatory therapeutic innovation, to achieve the best possible outcomes for patients. Their 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 Click on LinkedIn.

References

1. Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia (CONVOKE). ClinicalTrials.gov. Available from: https://www.clinicaltrials.gov/study/NCT05838625. Accessed August 2025.
2. CT-155 (BI 3972080): Prescription digital therapeutic. Boehringer Ingelheim. Available from: https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/clinical-pipeline/ct-155-bi-3972080-prescription-digital-therapeutic. Accessed August 2025.
3. Correll CU, Schooler NR. Negative Symptoms in Schizophrenia: A Review and Clinical Guide for Recognition, Assessment, and Treatment. Neuropsychiatr Dis Treat. 2020;16:519–534.
4. Schizophrenia. WHO. Available from: https://www.who.int/news-room/fact-sheets/detail/schizophrenia. Accessed August 2025.
5. Schizophrenia Fact Sheet. Treatment Advocacy Center. Available from: https://www.tac.org/reports_publications/schizophrenia-fact-sheet/. Accessed August 2025.
6. Boehringer Ingelheim and Click Therapeutics receive FDA breakthrough device designation for schizophrenia prescription digital therapeutic. Boehringer Ingelheim. Available from: https://www.boehringer-ingelheim.com/human-health/mental-health/schizophrenia/fda-grants-breakthrough-status-schizophrenia-treatment. Accessed August 2025.
7. Phan P, Mitragotri S, Zhao Z. Digital therapeutics in the clinic. Bioeng Transl Med. May 2023;8(4):e10536.
8. DTx Value Assessment & Integration Guide. DTx Alliance. Available from : https://dtxalliance.org/wp-content/uploads/2022/05/DTx-Value-Assessment-Guide_May-2022.pdf. Accessed August 2025.
9. Health Resources and Services Administration. Health Workforce Shortage Areas. Available from: https://data.hrsa.gov/topics/health-workforce/shortage-areas. Accessed August 2025.
10. Health Resources and Services Administration. State of the Behavioral Health Workforce, 2024. Available from: https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/state-of-the-behavioral-health-workforce-report-2024.pdf. Accessed August 2025.
11. Hany M, Rizvi A. Schizophrenia. StatPearls [Internet]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK539864/. Accessed August 2025.
12. Llerena K, Reddy LF, Kern RS. The role of experiential and expressive negative symptoms on job obtainment and work outcome in individuals with schizophrenia. Schizophr Res. 2018;192:148-153.
13. Kadakia A, Catillon M, Fan Q, et al. The Economic Burden of Schizophrenia in the United States. J Clin Psychiatry. 2022 Oct 10;83(6):22m14458.
14. Vaccaro J, Nili M, Xiang P, et al. Economic Burden Associated with Negative Symptoms Identified Through Natural Language Processing Among Patients with Schizophrenia in the United States. Schizophr Bull. 2025 Jun 3:sbaf073.