Though about one-third to one-half of people diagnosed with multiple sclerosis also live with symptoms of depression, they have very few effective treatment options addressing that aspect—and developing new pharmaceutical treatments can be daunting when faced with mapping out potential drug-drug interactions and their long-term effects on outcomes and safety.
Instead, prescription app developer Pear Therapeutics and its Big Pharma partner Novartis have begun testing a new digital treatment designed to be given alongside a disease-modifying therapy for relapsing MS.
Focused on the depressive symptoms patients may face, the Pear-006 app offers a combination of cognitive behavioral therapy, cognitive reframing and behavioral activation, mimicking the psychotherapeutic processes seen in face-to-face treatment sessions.
The companies’ first feasibility study will explore the clinical effects of the app’s branching treatment logic—which responds to cues provided by the patient in a conversational manner, using an interface similar to an instant messaging application.
“There will be an assessment that will say, ‘How are you feeling today?’ And the patient may say something like, ‘I’m angry,’ and it will say, ‘Tell us more about your anger,’” described Pear’s chief medical officer, Yuri Maricich.
“And so based on what the patient inputs, we're then building a series of therapeutic approaches that are displayed back to the patient, based on the information they entered,” either by typing it in themselves or by selecting from preset responses, Maricich told FierceMedTech.
The dialogue’s design stems from interviews with hundreds of patients, as well as close work with advocacy organizations and neurologists, to not only gauge how to best treat the disease but to better understand how patients approach, consider and talk about their condition. It’s also imperative for driving treatment adherence, which can be the name of the game for all therapies—pharmaceutical, digital or otherwise.
“One of the things we learned is that while patients will tell you they're depressed, they will also, at the same time, reject the idea that they have, quote-unquote, ‘Depression,’” Maricich said. “And so that's a key factor in how we wrap up the patient experience, in terms of the user interface and even the types of words they use.”
“Patients also don't, for example, say that they're having cognitive problems—they will tell you ‘I have brain fog,’” he said. “So we have been able to build up a library of terminology that patients have used, and then we feed those back as options.”
The app’s feasibility study, seen as akin to a phase 1/2 study, is expected to be completed over the next couple of months. Pear and Novartis hope to complete another two or three studies—evaluating efficacy, patient engagement and dosing—before filing for FDA approval.
And while Pear’s development programs have chased traditional, druglike clinical endpoints, measuring the dose of a digital therapeutic can be a little trickier.
The concept is largely the same: determine the unit in the software that will potentially have a biological effect, Maricich said. The company’s previously approved apps, for opioid and substance abuse disorders, included countable modules and therapy lessons, that demonstrated higher relative benefits as more were completed proficiently. But Pear’s data science team also tracks how often patients open the software, how long they interact with the app and other metrics.
Those may come into play as the company develops the rest of its pipeline, with apps planned in pain, oncology, cardiovascular disease and insomnia, to address not only the primary outcomes but the neurological and behavioral dimensions of those conditions as well.
“Feedback from patients is really critical,” Maricich said. “Because if we rest on our expertise, and biology and behaviors are always going to outdo us.”