What's Happening?
Boehringer Ingelheim and Click Therapeutics have unveiled data from their pivotal trial of the digital therapeutic CT-155 for schizophrenia. The trial, presented at the European College of Neuropsychopharmacology Congress, demonstrated the efficacy of CT-155 in addressing
negative symptoms of schizophrenia, such as apathy and social withdrawal. The phase 3 CONVOKE trial met its primary endpoint, showing a significant improvement in negative symptoms severity, measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale. The smartphone-based app provides interactive psychosocial intervention sessions, offering a digital alternative to face-to-face cognitive behavioral therapy. The trial results indicate a 62% relative improvement compared to a digital control arm, with high compliance rates among participants.
Why It's Important?
The development of CT-155 is significant as it addresses the unmet need for effective treatments targeting negative symptoms of schizophrenia, which are not adequately managed by existing antipsychotic drugs. If approved, CT-155 could become a first-in-class adjunctive treatment, enhancing the therapeutic options available for individuals with schizophrenia. The emergence of prescription digital therapeutics like CT-155 represents a potential shift in mental health care, allowing patients to access psychosocial interventions remotely. This innovation could improve treatment compliance and accessibility, particularly for underserved communities, and may lead to broader acceptance and integration of digital health solutions in psychiatric care.
What's Next?
Boehringer Ingelheim is preparing to discuss the trial data with regulatory authorities, in collaboration with Click Therapeutics. CT-155 has been granted breakthrough device status by the FDA, which may expedite its review process upon submission for approval. The partnership between Boehringer and Click Therapeutics, which includes additional digital therapeutic projects, underscores a commitment to advancing mental health treatment through innovative technologies. The successful approval and commercialization of CT-155 could pave the way for further development and acceptance of digital therapeutics in the healthcare industry.
