BOSTON, and SAN FRANCISCO, March 1, 2018—PEAR Therapeutics announced today that it has entered into a collaboration with Novartis to develop novel prescription digital therapeutics for schizophrenia and multiple sclerosis (MS). These digital therapeutics are software applications designed to effectively improve clinical outcomes for patients. The collaboration brings together Novartis’ expertise in neurological disorders, clinical development, and commercialization with PEAR’s leading experience in prescription digital therapeutic design and implementation.
The two companies plan to pursue approval for PEAR’s existing THRIVE™ digital therapeutic, which is a late stage therapeutic asset, supported by proof-of-concept efficacy data as well as long-term engagement data, across three clinical studies, consisting of over 1,000 patients diagnosed with schizophrenia. The parties will work together to develop a new therapeutic application to alleviate disease burden in patients with MS, which they will then seek to validate in clinical studies. PEAR’s prescription digital therapeutics are clinically-validated, FDA-regulated software applications that deliver evidence-based interventions to patients through mobile applications. Once FDA-cleared, they may be prescribed alongside drug therapies and have the potential to be developed to treat a range of diseases.
“We look forward to working with Novartis, an organization known for excellence in biomedical science, to develop much needed treatments for patients suffering from schizophrenia and multiple sclerosis,” said Corey McCann, M.D., Ph.D., President and CEO of PEAR Therapeutics. “Novartis shares our vision for prescription digital therapeutics that work alongside drugs to deliver superior patient outcomes. We believe this collaboration further supports the clinical viability of prescription digital therapeutics as an emerging treatment modality and we are poised to execute on that opportunity.”
“With widespread adoption of digital devices, prescription digital therapeutics could potentially play an important role in future treatment models for a range of diseases with high unmet medical need, used both alone and in combination with systemic agents,” said Jay Bradner, M.D., President of the Novartis Institutes for BioMedical Research.
PEAR Therapeutics obtained the first FDA clearance for a software application with a safety and efficacy label to treat patients in September 2017. In October 2017, PEAR received an Expedited Access Pathway (EAP) designation from the FDA for its reSET-O™ prescription digital therapeutic, the first of its kind designed for treating opioid use disorder. The collaboration involves research funding, an upfront payment, milestones, and royalties on net sales of the two products. As part of the collaboration, Novartis also invested in PEAR’s Series B financing.
About Prescription Digital Therapeutics
Prescription digital therapeutics are clinically validated, regulatory-cleared software applications that demonstrate safety and efficacy in randomized clinical trials to treat disease. They are designed to enhance clinical outcomes, and where clinically relevant may be combined with current treatment regimens including approved drug or device therapies. Prescription digital therapeutics usually include patient-facing applications, clinical assessment and outcomes tracking, clinician monitoring dashboards and HIPAA-compliant data storage.
About PEAR Therapeutics
PEAR Therapeutics is the leader in FDA-cleared prescription digital therapeutics. The company’s approach is to integrate clinically-validated software applications with previously approved pharmaceuticals and treatment paradigms to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. PEAR’s lead product, reSET®, is an FDA-cleared 12-week interval prescription therapeutic for Substance Use Disorder (SUD) to be used as an adjunct to standard, outpatient treatment. PEAR’s product development pipeline includes reSET-O™ for opioid use disorder (OUD) and additional prescription digital therapeutics in schizophrenia (Thrive™), combat posttraumatic stress disorder (reCALL™), general anxiety disorder (reVIVE™), pain, major depressive disorder, and insomnia, for which PEAR intends to obtain FDA clearance. For more details, please see www.peartherapeutics.com.