CT-155 showed a reduction in experiential negative symptoms as an adjunct to standard of care antipsychotic therapy from baseline to week 16, as measured by CAINS-MAP.
Boehringer Ingelheim and Click Therapeutics announced that the pivotal Phase III CONVOKE study of CT-155 (BI 3972080), an investigational prescription digital therapeutic (PDT), met its primary endpoint. The randomized, double-blind, controlled study investigated the effectiveness 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 experiencing negative symptoms. The study’s primary endpoint was change in experiential negative symptoms from baseline to week 16 as measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).
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In the CONVOKE study, CT-155 was well tolerated and demonstrated a favorable safety profile consistent with past studies.
“The 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.”
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Approximately 2.8 million adults in the U.S. live with schizophrenia, which places a profound burden on individuals, families and society. About 60% of people living with schizophrenia experience negative symptoms.
“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.”
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.
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).
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.
About negative symptoms of schizophrenia
Schizophrenia affects approximately 24 million people worldwide, and about 60% of people living with the condition experience negative symptoms. Negative symptoms are one of the three core symptoms domains of schizophrenia, along with positive symptoms and cognitive impairment. Negative symptoms include both experiential or expressive symptoms. Experiential negative symptoms include lack of motivation (avolition), decreased social interactions (asociality) and diminished ability to feel pleasure (anhedonia). Expressive negative symptoms refer to decreased expression of emotions (blunted affect) and reduction in speaking (alogia).
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.
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Source- GlobeNewswire
