Investigational App for Negative Schizophrenia Symptoms Meets Primary Trial Endpoint
An investigational prescription digital therapeutic targeting negative symptoms in patients with schizophrenia met its primary endpoint in a pivotal phase 3 randomized controlled study, developers Click Therapeutics Inc. and Boehringer Ingelheim announced.
The app, called CT-155 (BI 3972080), provides interactive psychosocial intervention techniques as an adjunct to standard antipsychotic therapy.
“Although treatments are being used to help manage negative symptoms, there are no US 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,” said Emmanuelle Clerisme-Beaty, US medical director and senior vice president of medicine at Boehringer Ingelheim Pharmaceuticals Inc., in a news release.
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The double-blind, multicenter CONVOKE study (NCT05838625) compared the effectiveness and safety of CT-155 to a digital control app in adults and older adolescents with schizophrenia and negative symptoms who were stable on antipsychotic medicine.
The use of CT-155, as an adjunct to standard of care over 16 weeks, was associated with a demonstrated change in experiential negative symptoms per the Clinical Assessment Interview for Negative Symptoms, Motivation, and Pleasure Scale, according to the companies. Additionally, CT-155 was well tolerated, with a favorable safety profile.
“Findings from CONVOKE provide the first phase 3 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 at 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.”
Further details are scheduled for presentation at the 38th Annual European College of Neuropsychopharmacology Congress’ Novel Therapeutics Symposium on October 13 in Amsterdam, the Netherlands.
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