German drugmaker Boehringer Ingelheim and Click Therapeutics said their phase 3 trial of a prescription digital therapeutic for the negative symptoms of schizophrenia met its primary endpoint.
Data from the phase 3 CONVOKE study of CT-155 were presented at the 38th annual European College of Neuropsychopharmacology Congress in Amsterdam. Full results will be published later, the companies said in an Oct. 13 news release.
CT-155 is designed to address “negative” symptoms—diminished emotion, loss of interest and social withdrawal—in adults with schizophrenia. By contrast, “positive” symptoms include hallucinations and delusions.
Prescription digital therapeutics are software-based medical treatments that require a healthcare provider’s prescription and must be authorized by the FDA.
“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,” Emmanuelle Clerisme-Beaty, M.D., Boehringer’s medical director in the U.S. and a SVP, said in the release. “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.”
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The phase 3 study tracked experiential negative symptoms through week 16; CT-155 beat a digital control, improving scores by 6.8 points vs. 4.2.
“This research underscores the importance of including innovative approaches in the treatment of schizophrenia,” Gregory Mattingly, M.D., an associate clinical professor at Washington University and principal investigator, said. “The emergence of prescription digital therapeutics, like CT-155, if approved, may hold the potential for patients to access psychosocial intervention from anywhere.”
Boehringer and Click first teamed up for schizophrenia-focused research in 2020 and expanded the partnership in 2022 to include additional aspects of the condition.
Schizophrenia ranks among the top 15 causes of disability and affects about 24 million people worldwide, the companies said.
While the collaboration between Boehringer and Click is showing positive results, other developers of prescription digital therapeutics, like Pear Therapeutics, have stumbled. Pear filed for Chapter 11 bankruptcy in 2023 after experiencing trouble securing insurance reimbursements and revenue for its products that included FDA-cleared programs for opioid and substance use disorders, as well as insomnia.
