Dive Brief:

• Novartis is set to test Pear Therapeutics’ digital therapeutic treatment for schizophrenia in a Phase 2 clinical trial.

• The experimental candidate, similar to Pear’s other approved digital therapeutics, consists of software providing cognitive behavioral therapy, social skills training, and illness self-management, paired with anti-psychotic medication.

• To assess the effect of the digital therapeutic, called Pear-004, Novartis will enroll approximately 100 schizophrenia patients taking standard of care medication​ and randomize them to receive either the experimental intervention or a sham treatment.

Dive Insight:

Over the past year, Pear has shown it can convince regulators of the safety and efficacy of digital therapeutics by winning approvals for its treatments for substance use disorder, and most recently, opioid use disorder. For Pear, those approvals are potentially just the start, though. Together with Novartis, the digital therapeutic pioneer wants to use software to treat a wide range of diseases.

The proof-of-concept clinical trial in schizophrenia marks an important point in Pear’s push to move into additional indications. So far, Pear has shown its apps can encourage sustained treatment in people with substance use disorders. Now, Pear must prove the same for schizophrenia, one of the top 25 causes of disability in the world.

Pear noted that while medication-only treatment can reduce symptoms like hallucinations and delusions, side effects like obesity and diabetes can deter patients from sticking to their regimen.

Novartis, which partnered with Pear in March, will run the multi-site Phase 2 clinical trial. The Swiss pharma company plans to enroll around 100 schizophrenia patients and assess the effect of 12 weeks of Pear-004 on their symptoms, as measured using the Positive and Negative Syndrome Scale.

The partners’ belief that Pear-004 can improve outcomes in schizophrenia patients is underpinned by evidence that psychosocial treatments, such as cognitive behavioral therapy (CBT), can have positive effects on people with the condition. However, as in substance-use disorders, access to these resource-intensive interventions can be limited, depriving some patients of the benefits.

Pear, which is part of FDA's digital health software Pre-Cert program pilot, thinks digital therapeutics can fill this gap between patient needs and treatment availability by providing software that is more scalable than face-to-face interactions. The idea is to replicate what works in face-to-face psychosocial interventions, such as the rewarding of certain positive behaviors, in an app that more patients can access and use between clinic visits.   

In addition to schizophrenia, Pear is also working with Novartis on an earlier-stage treatment for multiple sclerosis and has wholly-owned programs targeting insomnia, traumatic brain injury and a clutch of other indications.