Boehringer, Click DTx for schizophrenia clears pivotal trial

Boehringer Ingelheim and Click Therapeutics have revealed the data from their pivotal trial of digital therapeutic (DTx) CT-155 for schizophrenia, which has shown efficacy against some of the symptoms that are hardest to address with drug therapies.

At the European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam this week, the two partners presented data from the phase 3 CONVOKE trial – first teased in the summer – which showed CT-155 was able to counteract the negative symptoms of schizophrenia, like apathy and social withdrawal.

The study met its primary endpoint, which was the change in experiential negative symptoms from baseline to 16 weeks, measured using the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).

Users of the smartphone-based app – which delivers interactive psychosocial intervention sessions that provide a digital alternative to face-to-face cognitive behavioural therapy (CBT) – had a 6.8-point improvement of negative symptoms severity as measured by CAINS-MAP, which was highly statistically significant and a 62% relative improvement compared to a digital control arm.

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, so CT-155 has a shot at becoming a first-in-class, adjunctive treatment with antipsychotics for people with schizophrenia.

One perennial concern about managing schizophrenia is compliance with treatment, and on that topic there was encouraging data in CONVOKE, with more than two-thirds of those assigned to the app (70.4%) completing 15 weeks of use, which was just slightly below the control app (76.5%).

Lead investigator Gregory Mattingly of Washington University in St. Louis said that the study results "represent an important step forward in exploring how negative symptoms may be better understood, which is an area of long-standing unmet need in mental health care."

He added: "The emergence of prescription digital therapeutics, like CT-155, if approved, may hold the potential for patients to access psychosocial intervention from anywhere."

Boehringer said it was preparing to discuss the data with regulatory authorities in collaboration with Click. CT-155 has been awarded breakthrough device status by the FDA, so it could have a swift review when submitted for approval.

CT-155 is just one of several DTx apps the two companies 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.