Sam Brusco, Associate Editor01.04.24
Click Therapeutics and Boehringer Ingelheim announced that their co-developed, investigational CT-155 prescription digital therapeutic (PDT) has earned U.S. Food and Drug Administration (FDA) breakthrough device status.
CT-155 is a software for mobile devices that’s being studied for use with standard-of-care drug therapy and is designed to treat the negative symptoms of schizophrenia. The duo said it’s one of multiple digital therapeutics under joint development to treat schizophrenia.
“We are thrilled to receive this Breakthrough Device designation for CT-155 as it brings us one step closer to being able to provide additional treatment options to those living with schizophrenia, where there remains a significant unmet need due to a lack of access to psychosocial intervention therapies,” said Shaheen Lakhan, MD, Ph.D., FAAN, chief medical officer of Click Therapeutics. “Our unique therapeutic approach is on track to be the industry’s first-in-class treatment for the negative symptoms of schizophrenia.”
Right now, available antipsychotic medications are indicated for positive symptoms like hallucinations, disorganized speech, and behavior agitation. There aren’t currently approved drugs or devices available to treat schizophrenia’s negative symptoms, which are at the root of significant day-to-day functional impairment.
The duo said CT-155 is the first investigational PDT developed as part of the collaboration, which has been in effect since September 2020.
“This Breakthrough Device designation is an affirmation of the groundbreaking work by the Boehringer Ingelheim and Click Therapeutics teams to advance the standard of care in schizophrenia. Prescription digital therapeutics, like CT-155, represent the future of medicine. This designation brings us one step closer to that reality by enhancing our ability to work with the FDA on market authorization and accelerate access to this future treatment option,” said Austin Speier, chief strategy officer of Click Therapeutics.
CT-155 is a software for mobile devices that’s being studied for use with standard-of-care drug therapy and is designed to treat the negative symptoms of schizophrenia. The duo said it’s one of multiple digital therapeutics under joint development to treat schizophrenia.
“We are thrilled to receive this Breakthrough Device designation for CT-155 as it brings us one step closer to being able to provide additional treatment options to those living with schizophrenia, where there remains a significant unmet need due to a lack of access to psychosocial intervention therapies,” said Shaheen Lakhan, MD, Ph.D., FAAN, chief medical officer of Click Therapeutics. “Our unique therapeutic approach is on track to be the industry’s first-in-class treatment for the negative symptoms of schizophrenia.”
Right now, available antipsychotic medications are indicated for positive symptoms like hallucinations, disorganized speech, and behavior agitation. There aren’t currently approved drugs or devices available to treat schizophrenia’s negative symptoms, which are at the root of significant day-to-day functional impairment.
The duo said CT-155 is the first investigational PDT developed as part of the collaboration, which has been in effect since September 2020.
“This Breakthrough Device designation is an affirmation of the groundbreaking work by the Boehringer Ingelheim and Click Therapeutics teams to advance the standard of care in schizophrenia. Prescription digital therapeutics, like CT-155, represent the future of medicine. This designation brings us one step closer to that reality by enhancing our ability to work with the FDA on market authorization and accelerate access to this future treatment option,” said Austin Speier, chief strategy officer of Click Therapeutics.