For most of medicine’s modern history, getting a prescription from the doctor has prompted a trip to the drugstore.
Might it soon prompt a trip to the app store instead?
A handful of Boston companies have been developing what they call “digital therapeutics” — software that can be used either alone to treat a medical condition, or in combination with a drug. The software will be reviewed by the Food and Drug Administration — just like a new pill or medical device would — and ideally, some of its cost will be covered by insurance companies. And it may treat everything from opioid addiction to attention deficit disorder to diabetes.
One of the local companies, Pear Therapeutics, earned the FDA’s approval last September for a mobile app to help substance abusers stay clean. It is one of the first examples of a prescription digital therapeutic, supported by clinical trial results, to win FDA clearance. The Swiss pharmaceutical giant Novartis will market the app, starting later this year.
The app, dubbed reSET, helps people keep track of their moods and cravings, and offers training modules on topics like identifying situations that are likely to lead to a relapse, or recognizing negative thinking and shifting to a more positive outlook. It is designed for people with alcohol, methamphetamine, cocaine, and cannabis dependencies, and there is also software that allows a doctor to monitor the patient’s use of the app, and the data he or she enters. A clinical trial involving 507 people with substance use disorders found that 58 percent of those using the app (and receiving a reduced number of face-to-face therapy sessions) were still clean at the end of the 12-week trial, compared with 30 percent of those receiving the standard treatment of face-to-face therapy sessions.
Ray Tamasi of the nonprofit treatment center Gosnold Inc. has evaluated the software from Pear, and believes it holds promise. “My interest has been around how technology can help us with patients between visits,” says Tamasi. Gosnold operates both inpatient and outpatient treatment clinics, primarily on Cape Cod. Pear’s product, he says, “is primarily a tool for patients in outpatient programs. They come once a week for counseling, or every couple of weeks, and so there’s that space in between. It helps deal with the question of how do we support people to be sure that they sustain recovery. It’s creating a digital loop.”
But insurers must decide whether they will cover the cost of digital therapeutics. And there are issues when software must be prescribed by a doctor, says Brandon Bergman, associate director at the Recovery Research Institute, which is part of Massachusetts General Hospital. The need for a prescription can limit the number of people the treatment reaches, Bergman says. “This kind of model doesn’t necessarily leverage the ubiquity or the reach that is offered by digital and online resources,” Bergman says. Despite that, “ultimately it’s a good thing. There are lots of advantages when people can access empirically supported resources in between therapy sessions.”
Pear employs 75 people in Boston and San Francisco. In January, the privately held company pulled in $50 million in venture capital funding, on top of $20 million it raised earlier. CEO Corey McCann says that Pear hopes to attain five FDA approvals for digital therapeutics over the course of four years. “We’re in rapid expansion mode,” McCann says. “It’s really a ‘put your foot on the gas pedal’ situation.” The company’s second app will address opioid addiction, in combination with the drug buprenorphine, which is often prescribed to help people kick a heroin habit.
I first covered another digital therapeutics startup, Boston-based Akili Interactive, in 2012, as the company was first forming around academic research related to how specially designed video games might be used to treat cognitive disorders or enhance brain function. More recently, Akili has been studying how a video game it developed called Project: EVO can stimulate the neural pathways in the front part of the brain. Akili recently wrapped up a clinical trial involving almost 350 patients, which “sent people home with iPads instead of drugs,” says Eddie Martucci, the company’s chief executive. It found that the game improved focus and decreased impulsivity in children with attention deficit/hyperactivity disorder, commonly called ADHD. (But it didn’t do better than a control — a commercially available educational game — on some of the trial’s other measures of improvement.)
“A lot of people love to latch onto the idea that it’s a video game for ADHD that could be good for you,” Martucci says. But he says the goal of the company is to create various kinds of software to treat conditions like depression, multiple sclerosis, or autism spectrum disorder.
Creating digital therapeutics, he says, is somewhat similar to pharmaceutical development in that “the ways you think about running clinical trials and getting clinical validation is similar. But a lot of it is quite different. We employ creatives and game developers” who have experience in the video game industry, Martucci explains, and are skilled in designing products that people will want to engage with — medicine they will happily take. In May, the company raised $55 million in venture capital funding.
Another digital therapeutics company, Voluntis, has initially focused on software to help diabetics manage their disease and use the right dosage of a long-acting form of insulin. But it is also developing other applications that will help people with ovarian cancer and breast cancer manage the symptoms of the medication they take to treat it. Because the side effects of cancer drugs can be severe, explains Voluntis chief executive Pierre Leurent, some patients don’t take the medications as they are prescribed.
The company went public in June on the Euronext stock exchange in Paris, where it was founded. Voluntis has 120 employees, 20 of whom work at its US headquarters in Cambridge. That number, Leurent hopes, will double to 40 before long.
Late last year, Leurent decided to move to the States because, he explains, “growing Voluntis in the US is an absolute priority. Our ambition is to be a global leader in our space.”
Could Boston become the global leader in digital therapeutics? It’s too early to answer that question definitively, but the prognosis is looking good.