Pear Therapeutics (PEAR), is a venture-backed digital health company focused on the development of digital therapies and drug/software combinations to treat diseases with high unmet medical need. PEAR is a fully integrated digital therapeutics company, developing software-based interventions in compliance with FDA design and test requirements, testing the efficacy of these interventions in randomized clinical trials, leveraging clinical trial data to file for FDA approval to treat disease, and supporting payment of approved products via reimbursement codes and health economic analyses. The company has developed a pipeline of clinically validated digital therapies we call eFormulationsTM, and our lead program is on pace to be the first FDA-approved digital therapy, with commercial launch in 2017.
Our vision for 2017
Building on the success of reSETTM, PEAR has developed a portfolio of eFormulationsTM. reSET-OTM is on track to be the first FDA-approved drug/software combination; the product has successfully completed pivotal studies for the treatment of Opiate Use Disorder when used in combination with Buprenorphine. Based on randomized studies involving 465 patients, PEAR plans to submit reSET-OTM for FDA approval in 2H 2017. PEAR’s THRIVETM is the first digital therapy demonstrated to treat schizophrenia. The product has been examined in 3 clinical studies involving 1,279 patients; efficacy has been demonstrated as assessed by PANSS (the aggregate approvable endpoint for schizophrenia therapies) and patient engagement has been demonstrated beyond 6 months.
In 2017, PEAR will be enrolling a pivotal study evaluating THRIVETM in the treatment of schizophrenia. In addition, the Company has eFormulationsTM treating post-traumatic stress disorder (PTSD), Generalized Anxiety Disorder (GAD), post-surgical pain, Major Depressive Disorder (MDD), and insomnia.