Click claims FDA okay for first-in-class schizophrenia DTx

Click Therapeutics has won the first-ever FDA approval for a treatment for the negative symptoms of schizophrenia – a digital therapeutic (DTx) called Motivista.

Formerly known as CT-155, Motivista hit the target in the phase 3 CONVOKE trial, with the results showing that the smartphone app was able to help users achieve a reduction in negative symptoms – such as low motivation, reduced ability to experience and anticipate pleasure (anhedonia), and social withdrawal – when added to standard schizophrenia treatment.

While traditional antipsychotic medications can be highly effective at managing positive symptoms of schizophrenia, like hallucinations and delusions, they rarely address negative symptoms. Meanwhile, attempts to develop drug therapies that can tackle negative symptoms have so far proved fruitless, although several candidates remain in clinical development.

Click's smartphone-based app guides users through a structured 16-week course of cognitive behavioural therapy (CBT) and social skills training, and in the 457-subject CONVOKE study demonstrated statistically significant improvements in patients' motivation and pleasure compared to a digital control app.

Specifically, users achieved an average 4.2-point improvement in negative symptoms, measured using the CAINS-MAP scale from baseline to 16 weeks, compared with those in the control group.

That makes it an important option for schizophrenia patients battling negative symptoms, which can often be the most disabling aspect of the disorder.

"For decades, patients living with schizophrenia and the clinicians who care for them have had few options for addressing negative symptoms, despite the profound impact these symptoms can have on everyday life," said Click's chief executive David Benshoof Klein.

"This FDA authorisation represents an important step forward for a patient population that has long been underserved and demonstrates the potential of new digital treatment approaches to address some of the most persistent challenges associated with schizophrenia."

Motivista was developed for several years by Click and pharma partner Boehringer Ingelheim, although the latter handed back commercial rights to the prescription DTx earlier this year, shortly after the CONVOKE results were published.

While it surrendered a direct commercial interest in the app, Boehringer has promised funding for the rollout and remains involved in the development of other DTx, including follow-up schizophrenia app CT-156.

The changed relationship has sparked speculation that Boehringer may be shifting towards a more strategic investor role in digital health technologies.