BOSTON--(BUSINESS WIRE)--Today Pear Therapeutics, Inc. announced the start of a feasibility study for a prescription digital therapeutic (PDT) intended to treat depressive symptoms in people with Multiple Sclerosis (MS). Known as Pear-006, the PDT is intended to be used in combination with disease-modifying treatment. Pear Therapeutics is developing Pear-006 in collaboration with Novartis under the terms of an agreement announced in March 2018.
Clinicians estimate that between 35-50% of people with MS also have symptoms of depression1. Data show that by improving symptoms of depression, overall quality of life can improve for people with RMS2.
"There is a significant prevalence of depressive symptoms associated with MS and these patients lack treatment options," said Yuri Maricich, Chief Medical Officer at Pear Therapeutics. "We believe that Pear-006 has the potential to improve the outcomes of people with MS and quality of life by providing a way for patients to access treatment whenever they may need it, while also providing real-time data to clinicians that can inform ongoing management.”
“Digital therapies will play an important role in treating patients with MS and are part of our commitment to further strengthening Novartis’ leadership in this area,” said Ricardo Dolmetsch, Global Head of Neuroscience at Novartis Institutes for BioMedical Research. “Pear-006 has the potential to change how we treat these patients and initiation of this trial is an important first step in this journey.”
Prescription digital therapeutics represent a new treatment class in healthcare that blend the iterative design and development agility of software with the rigor and evidence-based process of pharmaceuticals. The development of Pear-006 has been informed using extensive input from people with MS, scientists, and neurologists. The study launched today will focus on clinical use of the therapeutic software.
“Clinical depression caused by MS is the single most dangerous (or harmful) and impairing aspect of this autoimmune disease, while simultaneously being the single most treatable if diagnosed and treated properly. With a lifetime prevalence of 50-60% and an incidence of 25%, depression, is as common as it is disabling,” said Adam Kaplin, M.D., Ph.D., Department of Psychiatry and Neurology at Johns Hopkins University School of Medicine. “Pear-006 offers a chance for people to take control of this critical aspect of their MS and institute their own treatment plan.”
Further studies on patient engagement, dosing and preliminary efficacy are planned for later in the year.
About Pear Therapeutics
Pear Therapeutics is the leader in prescription digital therapeutics. We aim to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including severe psychiatric and neurological conditions. Our lead product, reSET®, for the treatment of Substance Use Disorder, was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O™, for the treatment of Opioid Use Disorder, received marketing authorization from the FDA in December 2018. For more information, visit us at www.peartherapeutics.com.
1 “Prevalence of depression and anxiety in multiple sclerosis: A systematic review and meta-analysis,” https://www.ncbi.nlm.nih.gov/pubmed/28017241
2 "Depression is the main determinant of quality of life in multiple sclerosis: A classification-regression (CART) study,” https://www.researchgate.net/publication/7283899_Depression_is_the_main_determinant_of_quality_of_life_in_multiple_sclerosis_A_classification-regression_CART_study