Click, Boehringer DTx for schizophrenia passes phase 3 test

A digital therapeutic (DTx) that aims to treat negative symptoms of schizophrenia, like apathy and social withdrawal, has hit the target in a phase 3 trial.

The smartphone-based CT-155 app, co-developed by Click Therapeutics and Boehringer Ingelheim, was able to help users achieve a reduction in negative symptoms when added to standard schizophrenia treatment in the CONVOKE study, which is designed to support its potential approval as a prescription digital therapeutic (PDT).

The primary measure in CONVOKE was the change from baseline in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP) scale at 16 weeks compared to a control app.

CT-155 was better than the control app at hitting that endpoint, according to the two partners, although the data from the study is not ready to release and will be presented at the European College of Neuropsychopharmacology (ECNP) Congress on 13th October.

While antipsychotic drug treatment can help alleviate positive symptoms of schizophrenia, like hallucinations, disorganised speech, and agitation, negative symptoms have proved much harder to crack. At the moment, there are no therapies approved by the FDA specifically to treat negative symptoms of schizophrenia.

CT-155, which has been awarded breakthrough device status by the FDA, takes the form of interactive psychosocial intervention sessions that provide a digital alternative to face-to-face cognitive behavioural therapy (CBT) – which can often be hard to access even in countries with well-developed healthcare systems.

"Findings from CONVOKE provide the first phase 3 evidence supporting the potential of a prescription digital therapeutic as an adjunct to standard of care antipsychotic therapy to treat a core element of schizophrenia," said Shaheen Lakhan, chief medical and scientific officer of Click.

"The observed clinical benefit on experiential negative symptoms in this study, without additional known safety concerns, marks a critical advancement in understanding how we might address this long-unmet need."

CT-155 is one of several DTx apps Boehringer and Click are working on under a $500 million partnership, first formed in 2020 and expanded two years later to include a second app for schizophrenia (CT-156) and another $460 million in potential milestones.

While there's no word yet on filing plans for CT-155, Click already has a track record in bringing PDTs to the US market.

Last year, with Otsuka, it launched Rejoyn, the first PDT to be approved by the FDA for people with major depressive disorder (MDD), and earlier this year, it claimed FDA approval for CT-132, the first PDT to be cleared in the US for the prevention of attacks in people with episodic migraine.

Its portfolio also includes the AspyreRx app for people with type 2 diabetes, originally developed by Better Therapeutics, which Click acquired when Better was dissolved last year. Meanwhile, it is developing additional DTx for opioid use disorder, multiple sclerosis, obesity, atopic dermatitis, and cancer.