BOSTON--(BUSINESS WIRE)--Pear Therapeutics, Inc. today announced the initiation of a Phase 2, proof of concept study for its prescription digital therapeutic in development for schizophrenia. The treatment, known as Pear-004, is designed to deliver multimodal neurobehavioral interventions to improve symptoms and functioning of people with schizophrenia. Pear-004 includes social skills training, cognitive behavioral therapy for psychosis, and illness self-management training aimed at delivering efficacy in combination with standard of care anti-psychotic medication. The treatment is being developed in collaboration with Novartis, as part of an agreement announced in March 2018.
Schizophrenia affects about one percent of the global population and is a major cause of disability in the United States and developed world1,2. Standard of care treatment for schizophrenia is anti-psychotic medication. While existing anti-psychotic treatment has been shown to be effective in reducing the positive symptoms of schizophrenia such as hallucinations and delusions, side effects contribute to low rates of use and subsequent negative health outcomes, such as obesity and diabetes3. Further complicating the treatment landscape, counseling has been shown to provide benefit in addition to standard of care medication, but access to such psychosocial therapies is limited4.
Pear-004 may potentially help reduce patient symptoms through use in combination with anti-psychotic medications. It may also fill treatment gaps between clinic visits with access to evidence-based neurobehavioral treatments. With Pear-004, patients would have on-demand access to clinical content focused on the areas of greatest need as identified by people living with schizophrenia. Over the course of their prescription, patients are encouraged to engage with the content and treatment logic and integrate the treatment into their everyday lives.
“Schizophrenia is a serious and difficult disease to treat. Onset typically occurs between the ages of 16-30, and the prognosis can be dire as more than half of all patients face lifelong impairment. Patients often face significant gaps in care and few efficacious treatments without significant side effects exist,” said Yuri Maricich, M.D., Chief Medical Officer of Pear Therapeutics. “We believe Pear-004 can help redefine standard of care for schizophrenia patients by offering an accessible, clinically validated treatment to deliver enhanced efficacy in combination with anti-psychotic medication when and where the patient needs it.”
The efficacy of Pear-004 will be tested in a multi-site randomized controlled trial led by Novartis. The goal of the proof of concept trial is to evaluate the benefit of Pear-004 when used in combination with standard of care anti-psychotic medications. Approximately 100 patients with schizophrenia on standard of care anti-psychotic medication will be randomized to receive Pear-004 or a sham control for 12 weeks. The primary efficacy endpoint will be change in overall symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale.
The research and development path for prescription digital therapeutics consists of an iterative software development process informed by testing, feedback, and clinical evaluation in an agile fashion. Pear-004 exemplifies this process, with iterative development of this prescription digital therapeutic informed by input from numerous patients and clinical experts as well as multiple translational studies.
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®, treats Substance Use Disorder and 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 clearance from the FDA in December 2018. For more information, visit us at www.peartherapeutics.com.
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2 Knapp, M., Mangalore, R., & Simon, J. (2004). The global costs of schizophrenia. Schizophrenia Bulletin, 30(2), 279-293.
3 Lieberman, J. A., Stroup, T. S., McEvoy, J. P., Swartz, M. S., Rosenheck, R. A., Perkins, D. O., Keefe, R.S., Davis, S.M., Davis, C.E., Lebowitz, B.D & Severe, J. (2005). Effectiveness of anti-psychotic drugs in patients with chronic schizophrenia. New England Journal of Medicine, 353(12), 1209-1223.
4 Dixon LB, Dickerson F, Bellack AS, et al. The 2009 schizophrenia PORT psychosocial treatment recommendations and summary statements. Schizophrenia Bulletin. 2010;36(1):48–70.