A years long collaboration between Click Therapeutics and drugmaker Boehringer Ingelheim exploring the potential of digital apps in schizophrenia therapy will now be put to the test in the clinic.
The pair has launched a randomized, pivotal study aimed at treating what are termed as the “negative symptoms” of schizophrenia among adult patients—that is, symptoms that take away from a person’s life such as disabling losses of emotion or interest, or withdrawing from social situations. Positive symptoms, meanwhile, include the creation of hallucinations and delusions.
Current antipsychotic medications have largely focused on the latter, the companies said in their announcement, leaving behind a large unmet need for “precision psychiatry” treatments that specifically target negative symptoms.
“This first-in-class study brings us closer to realizing our approach of offering personalized care in mental health, from initial diagnosis through ongoing disease management to long-term support,” said Vikas Mohan Sharma, Boehringer Ingelheim’s therapeutic area head in central nervous system, retinal health and emerging areas.
The clinical trial is set to enroll about 430 participants across the U.S. who will go through a four-month program that combines Click’s smartphone app-based digital therapeutics with standard-of-care drug therapies.
Boehringer Ingelheim first tapped Click for a schizophrenia-focused research collaboration in late 2020 before later expanding the partnership’s mandate in late 2022 to include additional aspects of the condition. The companies estimate schizophrenia affects 24 million people worldwide, and it ranks as one of the top 15 causes of disability with an increased risk of early death.
Click has also been developing digital offerings aimed at smoking cessation, major depressive disorder and insomnia, among others, as well as a program for migraines that recently received a breakthrough tag from the FDA.
Other developers of prescription digital therapeutics have seen their work cut short. Pear Therapeutics—which had developed pioneering, FDA-cleared programs for opioid and substance use disorders as well as insomnia—filed for bankruptcy last month and laid off nearly all of its staff after saying it had difficulties securing insurance reimbursements and revenue for its products.
Over the past few years, Pear had touted partnerships with drugmakers such as Novartis, Sandoz and others while raising tens of millions through venture capital funding rounds and a SPAC deal to go public.