Developing digital prescription therapeutic regimens for substance abuse and more.
Founder and CEO: Corey McCann
Based: Boston, Massachusetts
The scoop: The concept of software-as-a-drug has come a long way in recent years, and what was once scoffed at has been brought further into the mainstream, in part because of the work done by Pear Therapeutics.
While companion smartphone apps have previously been eyed as potential value-add propositions, or to boost adherence to more traditional pharmaceutical therapies, Pear has moved to validate standalone programs using the same gold-standard methods and single-variable studies that you would see for an injection or a pill.
“We're not asking anyone to consider a novel clinical trial structure, and we're not asking anyone to think about a new endpoint—we're only asking people to consider that the effect has been produced by software,” Pear CEO Corey McCann tells FierceMedTech.
The company aims to develop digital therapeutics that reproduce the changes seen in a patient’s neural circuitry following traditional, face-to-face sessions of cognitive behavioral therapy. And by allowing its treatment to be downloaded over-the-air, Pear aims to provide easier access to the 20 to 30 million people in the U.S. with a substance abuse disorder, of which only 4 to 5 million currently receive any treatment, McCann says.
“That number is very different than what you would see for hypertension or hypercholesterolemia,” he says. “This is a different world.”
What makes Pear fierce: Pear first received a de novo clearance from the FDA for its prescription digital therapeutic, reSET, for substance abuse disorders in September 2017. The mobile app complements outpatient therapy programs for disorders involving alcohol, cocaine, marijuana and stimulants, but not opioids.
Opioid abuse gained coverage through the more-recent reSET-O app, cleared by the agency last December, which consists of a 12-week course alongside medication-assisted therapy with buprenorphine. In addition to interactive lessons that challenge harmful behaviors and help develop coping strategies, the app also allows patients to self-report cravings and triggers to their physician.
The commercialization of both reSET and reSET-O are being led by Novartis’ Sandoz unit and a dedicated sales force, representing the first time that a Big Pharma has sold a piece of software, McCann says.
Their reach will get a boost from a $64 million series C financing round that Pear announced at the top of the year—which will also help fuel the development and acquisition of digital therapeutics in other indications, as well as to help continue to gather the clinical evidence needed to drive adoption of the digital therapeutics.
“But the term ‘digital therapeutic’ is actually a bit of an undersell,” McCann says. “We also collect everything about engagement, and we push patient-facing assessments. We're able to know when it's working, why it's working, and how it's working in every single patient. That is incredibly valuable.”
For example, Pear has seen strong correlations between the number of app modules completed and clinical outcomes, in addition to tracking real-world use. “We actually have a dose-response curve that we've published that is just like you would expect to see for a drug,” he says. “So for a drug development nerd, it's unbelievably rewarding.”
And while Pear has been aggressive in its partnering with pharma companies and academia, it has been developing its own internal candidates as well: Its third asset, focused on insomnia, currently has datasets under review by the FDA.
Other apps, for schizophrenia and multiple sclerosis, are being developed with the Novartis Institute for Biomedical Research. The schizophrenia product is currently enrolling patients for the equivalent of a phase 2b study, while the multiple sclerosis app is expected to begin its first human testing by the end of next month.
But one of the main goals of Pear is to build a discovery engine for digital therapeutics. The company’s development team scans about 500 different assets and potential therapy approaches—including in oncology, respiratory and cardiovascular diseases—that could be digitized and packaged as a downloadable treatment.
“One of the reasons why we find this whole space incredibly exciting is that this is not a CNS opportunity, this is not an addiction opportunity—this is really an opportunity that spans therapeutic areas,” McCann says. “And when you start to understand the depth and breadth of the space, there's probably more than 100 of these assets to be created.”