Accessible on mobile devices, CT-155 PDT is designed to treat the negative symptoms of schizophrenia and being assessed for use adjunctive to standard of care pharmaceutical therapy
FDA grants breakthrough status to schizophrenia digital therapeutic. (Credit: jesse orrico on Unsplash)
Click Therapeutics and Boehringer Ingelheim have received the US Food and Drug Administration (FDA) Breakthrough Device designation for CT-155, a prescription digital therapeutic (PDT) for schizophrenia.
The investigational CT-155 PDT is a software designed to treat the negative symptoms of schizophrenia.
Accessible on mobile devices, the tool is being assessed for use adjunctive to standard-of-care pharmaceutical therapy.
CT-155 is one of the several digital therapeutics under joint development by both firms for schizophrenia treatment.
This evidence-based PDT is said to provide psychosocial intervention techniques to those with negative symptoms of schizophrenia.
If authorised, CT-155 can provide a user-friendly, clinically proven mobile medical intervention that digitises behavioural therapy and accompanies the person day-to-day.
Click Therapeutics chief medical officer Shaheen Lakhan said: “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.
“Our unique therapeutic approach is on track to be the industry’s first-in-class treatment for the negative symptoms of schizophrenia.”
Click said that the CT-155 programme has accomplished all development milestones and generated supportive data in several clinical learning trials.
Based on these results, the firm started the CONVOKE registrational clinical trial in May 2023.
CT-155 is the first investigational PDT developed under the partnership between Click Therapeutics and Boehringer Ingelheim, which went into effect in September 2020.
The collaboration has since grown to include a second experimental prescription-based digital therapy that was revealed in December 2022.
It can be used both alone and in conjunction with medication therapy to help individuals with schizophrenia achieve favourable clinical outcomes.
Boehringer Ingelheim mental health franchise US head Christine Sakdalan said: “The FDA Breakthrough Device designation is an important milestone towards our goal of addressing the unmet medical needs in mental health and providing an innovative, future treatment option to enable people with schizophrenia to thrive.”