PEAR Therapeutics to Collaborate with Novartis to Develop Prescription Digital Therapeutics
Published: Mar 01, 2018
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.