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