Daniel Schoener, Senior Director R&D & IVD Advisor/Freelance
We live in the digital era. One app tracks our sleep and wakes us up at the best time, and another one records our steps. Siri translates our verbal needs into text requests and reads us back the result. Alexa picks the right music and lighting for our homes. Information technology is about to permeate every aspect of our lives. When I learned earlier this year that the FDA had approved the first digital therapies, I was truly intrigued and somewhat mystified. Digital therapy? Is medicine becoming digital, as well?
According to the definition of the trade association, DtxAlliance, Digital therapeutics delivers evidence-based therapeutic interventions to patients to prevent, manage, or treat a medical disorder or disease. Powered by high-quality software that combines medical-grade content, patient motivation, and connectivity to the healthcare system, they differentiate themselves from the vast amount of wellness apps through scientific evidence, clinical data, and regulatory approvals. To understand more, let’s look at some of the key players and how their products address addiction, ADHS, and Alzheimer’s.
Pear Therapeutics is the furthest advanced company in the market. In the last two years, it has received two FDA approvals using an accelerated regulatory pathway and has been commercially backed by drug giant Novartis. Both products, reSET and reSET-O, target substance addiction through cognitive behavioral therapy (CBT), a method that changes thinking and behavior patterns through education and positive reinforcement. Using the apps, patients complete lessons and answer a series of quiz questions. They also report medication usage and substance cravings, triggers, and use. The more recent breakthrough product, reSET-O, is a combination therapy with buprenorphine, a drugused to treat opioid addiction, acute and chronic pain. A clinical study with 117 opioid addicts showed increased adherence to a 12-week recovery program: with the digital therapy, 82.4% of the patients completed the entire program, only 68.4% without it. PearTherapeutics has generated $17.5M in revenue in 2019 and has new digital treatments for schizophrenia, insomnia, and epilepsy in its pipeline.
The company Lumme uses CBT to help users quit smoking. While Pear’s products rely on patient self-reporting, Lumme uses machine learning to detect a cigarette craving automatically.
As the therapeutic area grows, technologies mature, and clinicians start to adopt the products routinely in their practice, digital therapies will unleash their full potential
Their app uses data from commercially available smartwatches to track the user’s arm movement and detects smoking gestures with an accuracy of 95%. The software predicts cigarette cravings 6 min before the users feel them and sends notifications that encourage them not to smoke. Lumme’s product acts on its own as a stand-alone treatment for nicotine addiction. According to the first randomized clinical trial data Lumme reports the highest quit rates of any product in the market, with 50% of participants of the study being smoke-free After eight weeks.
An example of a digital therapeutics company using gamification is Akili Interactive. Its most advanced product in development, AKL-T01, is a digital therapeutic designed to improve attention in children living with attention-deficit/hyperactivity disorder (ADHD). While playing what feels like a videogame, the kids receive sensory and motor stimuli that target the prefrontal cortex, a brain area affected in ADHD. In a clinical study with 348 subjects the software significantly improved attention measures in children ages 8 to 12 with ADHD after four weeks compared to control. Akili Interactive has filed for FDA clearance of AKL-T01 and i s also studying the technology in other diseases and disorders, including autism spectrum disorder, depression, and multiple sclerosis. The firm has received funding from Amgen and Merck.
Dtherais the only publicly-traded digital therapy company to date and is taking on one of the biggest healthcare problems of the aging population: dementia. This disease area has explicitly been hard to tackle with traditional treatment; 430 clinical trials conducted in the last decade resulted in only one approved drug for Alzheimer’s. Dthera’s digital therapy product DTHR-ALZ has been granted breakthrough device classification by the FDA and intends to treat Alzheimer’s through reminiscence therapy: patients suffering from memory loss are presented with familiar pictures, music, or other materials from the past to activate their memory. A customized tablet computer combines these elements with facial expression detection and artificial intelligence algorithms that can measure the patient’s response to the presented materials and learn to present the content that triggers a positive reaction. In 2017 the company reported a proof-of-concept study with 14 participants thats howedsignificantly reduced agitation and depression in Alzheimer’s patients when using the device. A report of their full clinical study is pending.
Based on the early successes in the field, digital therapeutics have enjoyed increasing attention among investors. In 2018 the top 3 digital therapeutics companiesraised about $170M in funding to continue their programs. According to Price Waterhouse Coopers, a survey conducted in 2019 revealed that 50 percent of consumers said they would be somewhat or very likely to try an FDA-approved app or online tool for the treatment of a medical condition. The FDA, in turn, has created a dedicated pilot program for software pre-certification for solutions such as digital therapies, with currently nine companies being enrolled in it. Currently, the Business Intelligence platform Crunchbase list 79 digital therapeutics firms, and Market Watch estimates the digital therapeutics market to grow to $7B by 2024 at a 21% growth rate.
Today, most digital therapies focus on conditions affecting the central nervous system and psychiatric conditions. There is presently no indication that they will replace drugs in a broader set of diseases in the near future. As the therapeutic area grows, technologies mature, and clinicians start to adopt the products routinely in their practice, digital therapies will unleash their full potential. To this end, they need to continue to prove their safety and effectiveness with strong clinical data.
Many mental health disorders are poorly addressed by the healthcare system today. For affected patients, there is now a digital spark of hope for therapeutic advancement at the horizon.