Pear Therapeutics announced that a first patient is being treated in Part 2 of its feasibility trial of Pear-006, a software application that, given along with a disease-modifying therapy, delivers cognitive behavioral therapy and other neurobehavioral approaches to ease depression in people with multiple sclerosis (MS).
PDTs are basically software applications intended to treat diseases or lessen their symptoms. They are built based on scientific evidence — which includes demonstrations of safety and efficacy in randomized clinical trials — required by the U.S. Food and Drug Administration (FDA) for being considered class II A medical devices.
“Between 35-50% of people with MS have symptoms of depression, yet only inadequate treatment options remain to improve quality of life. Pear Therapeutics understands the importance of not only addressing this unmet need, but doing so in a way that would allow easy access for patients,” Yuri Maricich, MD, chief medical officer at Pear Therapeutics, said in a press release.
“As pioneers in prescription digital therapeutics, we take pride in leading the first decentralized trial for a digital therapeutic in this patient population, further exploring … and advancing research for the MS community,” Maricich added.
To create Pear-006, the company said it incorporated insights from patients, scientists, and neurologists. The software, in the form of an app, is intended to be used in combination with disease-modifying treatments (DMTs).
Pear launched this first clinical study of Pear-006 in May. The study, a randomized and controlled trial, will determine the feasibility and usability of Pear-006 in about 30 people with relapsing forms of MS. Participants will be given the digital therapy for eight weeks, and data collected will be used to evaluate dosing, patient use, engagement, and other clinical outcomes.
Part 1 of this two-part study began in May, and according to Pear had encouraging results. Should the outcome of this first feasibility study show promise, other trials in MS patients will be planned, the company said.
Pear and Novartis are also working on a similar PDT, called Pear-004, to treat schizophrenia.