Boehringer prepares schizophrenia app for FDA submission

Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care and the business and policy challenges to realizing tech’s promise. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

HANOVER, N.H. — Boehringer Ingelheim this week provided more details about a late stage clinical trial of an app designed to treat under-addressed symptoms of schizophrenia and revealed the company is preparing to submit the app to the Food and Drug Administration for clearance.

Developed with Click Therapeutics, the app, CT-155 is a 16-week treatment that adapts key elements of established face-to-face psychosocial treatments for schizophrenia as an adjunct to antipsychotic drug treatment. Schizophrenia affects millions of people in the U.S. and is commonly associated with psychotic behavior and delusions. However, there are also common and often serious negative symptoms, including lack of motivation and the inability to experience pleasure, for which there are no approved drugs.

In topline results of a 464-participant randomized control trial first released in October, Boehringer Ingelheim revealed that users of the experimental app improved on a rating scale for these symptoms compared to a group that used a control app. Importantly, the treatment met its primary endpoint by passing a prespecified threshold for effect size.