Boehringer and Click Therapeutics present pivotal data for investigational prescription digital therapeutic CT-155 showing a statistically significant reduction in negative symptoms of schizophrenia
- CONVOKE was the first and only pivotal trial to show a statistically significant reduction in experiential negative symptoms of schizophrenia as an adjunct to standard of care antipsychotic therapy, as presented at ECNP Congress1
- Treatment with CT-155 demonstrated a Cohen's D effect size of -0.36 (p value= 0.0003) reflective of a 6.8-point improvement of negative symptoms severity as measured by CAINS-MAP at 16 weeks (vs. 4.2-point in digital control arm), representing a 62% relative improvement1
- The majority of participants used their assigned app until week 15 (70.4% for CT-155 and 76.5% for digital control app)1
RIDGEFIELD, Conn. and NEW YORK, Oct. 13, 2025 /PRNewswire/ -- Boehringer Ingelheim and Click Therapeutics today shared data from the pivotal Phase III CONVOKE study (NCT05838625) of CT-155 (BI 3972080), an investigational prescription digital therapeutic (PDT) used as an adjunct to standard of care antipsychotic therapy for experiential negative symptoms of schizophrenia. The data were presented during an oral session at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam and full results will be published at a later date.1
The study met its primary endpoint, which was change in experiential negative symptoms from baseline to 16 weeks as measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).1,2 Treatment with CT-155 demonstrated a Cohen's D effect size of -0.36 (p value= 0.0003) reflective of a 6.8-point improvement of negative symptoms severity as measured by CAINS-MAP at 16 weeks (vs. 4.2-point in digital control arm), representing a 62% relative improvement.1
"The positive primary endpoint results observed from the CT-155 Phase III trial represent an important step forward in exploring how negative symptoms may be better understood, which is an area of long-standing unmet need in mental health care," said Gregory W. Mattingly, MD, Associate Clinical Professor at Washington University in St. Louis, MO and Principal Investigator in Clinical Trials for Midwest Research Group and Founding Partner of St. Charles Psychiatric Associates. "This research underscores the importance of including innovative approaches in the treatment of schizophrenia. The emergence of prescription digital therapeutics, like CT-155, if approved, may hold the potential for patients to access psychosocial intervention from anywhere."
The majority of participants used their assigned app until the end of week 15 (70.4% for CT-155 and 76.5% for digital control app).1 Patients demonstrated engagement with CT-155 during the CONVOKE study, completing activities on a median of 76 out of 112 possible study days (16 weeks).1 Patients in the digital control arm completed activities on a median of 92 out of 112 possible study days.1 High engagement with both the CT-155 and digital control apps confirms that CT-155's observed benefits in the trial stemmed from its unique content, not differences in engagement or app design.
"CT-155, which integrates psychosocial interventions delivered using an adaptive goal-setting technique, is the first investigational PDT to show reduction in experiential negative symptoms of schizophrenia in a pivotal trial," said Emmanuelle Clerisme-Beaty, Medical Director US, SVP Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "In collaboration with Click Therapeutics, we developed CT-155 aiming to address the dual challenges of accessibility and consistency of psychosocial therapy use for people living with negative symptoms of schizophrenia. We look forward to advancing discussions with regulators with the goal of helping patients."
CT-155 was well-tolerated and demonstrated an adverse event (AE) profile consistent with past studies. The AE rates with CT-155 and the digital control arm were 8.3% vs 13.4%, respectively.1 There were no trial discontinuations attributed to CT-155 and two (2) for the digital control arm. There were no serious AEs related to either group.1
Approximately 3.7 million adults in the U.S. live with schizophrenia, which places a profound burden on individuals, families and society. 3,4 About 60% of people living with schizophrenia experience negative symptoms.5
"The design and development of CT-155 was informed by an iterative patient-centered approach with more than 150 people living with schizophrenia,2 ensuring the therapeutic aimed to address the real-life challenges that people with experiential negative symptoms face, such as lack of motivation, social connection, and ability to feel pleasure," said Austin Speier, Chief Strategy Officer, Click Therapeutics. "For decades, negative symptoms have represented one of the greatest unmet needs for people living with schizophrenia, and we are proud to be exploring CT-155 as a potential new treatment modality in mental health."
In addition to CONVOKE, Boehringer Ingelheim is conducting the multicenter Enspirus study (NCT06791122) to evaluate the clinical effectiveness, engagement, healthcare resource utilization, and safety of CT-155 in patients with experiential negative symptoms of schizophrenia in a real-world-like setting.6
In 2024, the U.S. Food and Drug Administration (FDA) granted CT-155 Breakthrough Device Designation.7
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 for people living with schizophrenia and experiencing negative symptoms.2,7,8 CT-155 is designed to address defeatist beliefs and lack of motivation.2 CT-155 uses tailored goal-setting that aligns with each patient's current level of functioning (adaptive goal setting) to promote engagement in real-world activities (behavioral activation).2 Additionally, CT-155 delivers therapeutic interventions aimed at helping patients successfully achieve their goals (cognitive restructuring, social skills training, positive affect training, distress tolerance skills).2 CT-155 is being developed by Click Therapeutics, Inc. and Boehringer Ingelheim.2
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 sponsored by Click Therapeutics and Boehringer Ingelheim that evaluated 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.2 The study enrolled participants (≥18 years) with schizophrenia who were stable on antipsychotic medication.2 The study was funded by Boehringer Ingelheim.
The primary endpoint evaluated improvement in experiential negative symptoms as an adjunct to standard of care as measured by changes from baseline at week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).2
CAINS is a second-generation negative symptoms scale that was developed to reflect updated conceptualizations of negative symptoms, as recommended by the National Institute of Mental Health and the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative.2 CAINS-MAP offers a detailed assessment of experiential negative symptoms.2
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 16.2
The full CONVOKE results will be published at a later date.
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.9,10 PDTs can provide patient-centered and flexible care to meet the patient where they are in their treatment journey.9,10 These interventions 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.9,10,11,12
About negative symptoms of schizophrenia
Schizophrenia affects approximately 24 million people worldwide, and about 60% of people living with the condition experience negative symptoms.3,5 Negative symptoms are one of the three core symptoms domains of schizophrenia, along with positive symptoms and cognitive impairment.14 Negative symptoms include both experiential or expressive symptoms.5,14 Experiential negative symptoms include lack of motivation (avolition), decreased social interactions (asociality) and diminished ability to feel pleasure (anhedonia).5,15 Expressive negative symptoms refer to decreased expression of emotions (blunted affect) and reduction in speaking (alogia).5,14
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 2019.15 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.16
Although treatments are being used to help manage negative symptoms, there are no U.S. regulatory authority-approved treatments indicated specifically for negative symptoms of schizophrenia to date.5,7
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.
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.
Content does not necessarily reflect opinions of ECNP.
Media Contacts
Boehringer Ingelheim:
Jennifer Huron
Senior Associate Director, Corporate Affairs
E-Mail: jennifer.huron@boehringer-ingelheim.com
Phone Number: +1 (203) 448-1263
Click Therapeutics:
Emily Flint
VP Marketing
E-Mail: pr@clicktherapeutics.com
Phone Number: +1 (978) 412-7273
References
View original content:SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.; Click Therapeutics