Click bags FDA breakthrough tag for schizophrenia DTx

Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia, like social withdrawal and apathy, that tend not to respond well to antipsychotic drugs.

The therapy is being co-developed with Boehringer Ingelheim as a smart device-based app and is intended to be used alongside drug treatment for schizophrenia, and is one of several DTx apps the two companies are working on under a partnership formed in 2020.

Schizophrenia is one of the 15 leading causes of disability worldwide and, while drug treatment can help alleviate positive symptoms like hallucinations, disorganised speech, and agitation, negative symptoms have proved much harder to crack.

One approach that has been shown to work is psychosocial intervention therapies like cognitive behavioural therapy (CBT), but access to these tends to be scant and fragmented even in countries with developed healthcare systems. Digital health approaches offer a way to overcome those limitations if they can be shown to work in clinical testing.

Boehringer and Click expanded their original $500 million alliance on CT-155 in 2022 to include a second app for schizophrenia, adding another $460 million in potential payments.

A pivotal clinical trial of the two DTx – including CT-155 – started in May 2023 to gauge their effects on negative symptoms in schizophrenia patients aged 18 and over when used as an adjunct to pharmacological therapies.

Called CONVOKE, the 16-week study is enrolling a target of 432 patients, with results due in the middle of 2024. The main efficacy endpoint of the study is the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure (CAINS-MAP) scale.

“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, Click’s chief medical officer.

“Our unique therapeutic approach is on track to be the industry’s first-in-class treatment for the negative symptoms of schizophrenia,” he added.

Click also has a collaboration underway with Otsuka, worth $300 million, focusing on the development of a DTx for major depressive disorder (MDD), and in September teamed up with Indivior on DTx for substance use disorders. Its in-house pipeline is led by a DTx candidate for migraine.