Click Therapeutics’ prescription digital therapeutic (PDT) CT-155 has been granted Breakthrough Device designation by the FDA for the treatment of negative symptoms of schizophrenia in adults. The smartphone app, developed in collaboration with Boehringer Ingelheim, is currently being investigated in the CONVOKE study (NCT05838625) as a pharmaceutical therapy.

The CONVOKE study is a randomized, multicenter, 16-week trial evaluating the efficacy and safety of two prescription digital therapeutics in addition to standard of care (SOC) therapy for the treatment of negative symptoms of schizophrenia in late adolescence and adults. This PDT is part of a series of digital therapeutics jointly developed by Click and Boehringer for the treatment of schizophrenia.

The Breakthrough Devices Program is designed for devices that have the potential to provide more effective treatment than existing methods for life-threatening diseases. It aims to expedite the development and evaluation of new medical devices that meet the criteria for being considered breakthroughs in the US.

Shaheen Lakhan, MD, PhD, FAAN, chief medical officer of Click Therapeutics, expressed that the breakthrough designation is a significant step forward in offering additional treatment options for individuals with schizophrenia, addressing the substantial unmet need for access to psychosocial intervention therapies. He also highlighted that their approach is on track to become the industry’s first-in-class treatment for the negative symptoms of schizophrenia.

Schizophrenia is a leading cause of disability worldwide, affecting approximately 24 million people today. The FDA’s recognition of CT-155 as a Breakthrough Device underscores the potential impact of digital therapeutics in addressing the unmet needs of individuals with schizophrenia.