Proteus Digital Health announced interim study results from a randomized control study of its Proteus Discover timed with the American College of Cardiology event, ACC.16, in Chicago this week. The study included 96 patients with uncontrolled hypertension and type 2 diabetes and showed that a majority of the patients using the digital offering achieved the blood pressure target at week four.
The Proteus digital medicine platform is a medication management and adherence system that includes measurement tools like sensor-enabled pills, a peel-and-stick biometric sensor patch worn on the body, and companion smartphone apps. The patch records when a pill is ingested and can also track other things like sleep patterns and physical activity levels. The ingestible sensor component secured FDA clearance in July 2012, while the company’s sensor-laden patch got FDA clearance in 2010.
The ingestible sensor is made up of an integrated circuit, two "active" layers, "excipient materials" that provide adhesive, and a "skirt, which contains ethyl cellulose, hydroxypropyl cellulose, and triethyl citrate." The company explains in the paper that the pill is made entirely of ingredients found in the food chain.
The full results of Proteus' IRB-approved study are expected to be released later this year, but the interim results released by the company are as follows: For the 12-week, 96 patients (58 years old on average; half males) were enrolled with uncontrolled hypertension, meaning systolic blood pressure (SBP) at or over 140 mm Hg and type 2 diabetes (A1C ≥7%) who had failed at least two anti-hypertensive medications plus metformin and/or sulfonylurea. Participants either received Proteus Discover for four weeks, 12 weeks, or usual care. The primary outcome measured was SBP change at week four and secondary outcomes included change in diastolic blood pressure and proportion of subjects at BP target ( below 140/90 mm Hg). It also explored change in LDL in a subset of patients on sensor-enabled atorvastatin. That said, the interim results only include the BP and LDL outcomes at week four.
By the fourth week, some 85 percent of subjects using the digital offering (n=72) and 33 percent of the usual care arm (n=24) achieved the BP target. According to the company: "Proteus Discover users had a greater reduction in SBP than usual care (digital medicine: -23±2 mm Hg; usual care: -14±4 mm Hg). The digital medicine offering arm also had a greater reduction in DBP (digital medicine: -9±2 mm Hg; usual care: -5±2 mm Hg). The LDL changes were -18±7 for digital medicine vs. 1±2 mg/dL for usual care; baseline mean LDL levels were 110±4 and 97±5 mg/dL respectively."
On the sidelines of the HIMSS annual conference in Las Vegas last month, Proteus Digital Health CEO Andrew Thompson gave MobiHealthNews an update on the company's progress and helped frame the impending release of these and future study results.
"We’re not a drug company, not a device company, not a data and analytics company. We’re all those things in some combination," Thompson said. "Our product Discover, is like Tesla’s model S. We are showing the world what drugs with digital drive trains look like, just like Tesla is showing the world what a car with an electric drive train looks like... They are definitely worth tens of billions of dollars and it is not because they are going to be the biggest car company in the world or because they are going to sell 50,000 cars. It’s because everybody is now betting that when the automotive industry goes electric they will get the technology from Tesla."
Thompson says if you think of Proteus that way, it already has a "BMW" too since it has a deal with pharmaceutical company Otsuka for its Abilify brand, which is poised to be one of the first medications to embed Proteus ingestible sensors.
"I’ve got my BMW, that’s Otsuka. Right? Because BMW powers its electric cars with Tesla technology. Great, so I have my product and I have an engaged licensed product. So I have a customer, a partner who is using my technology, my regulatory pathway, my product architecture, my clinical evidence standards, my commercial model to bring a new category of therapeutic product to market. Over time if you see that unfolding, the more I do with my own products, the more I’m going to have engaged licensed products. The goal here isn’t for Proteus to become the biggest healthcare company in the world, it’s to have the entire pharmaceutical industry embrace this idea that we can have medicines that combine measurement, feedback, and behavioral cues and our products are actually digital objects that, that when required, can create data that supports much more appropriate health outcomes."
This week's study results teaser is just the beginning of Proteus next phase of sharing how its digital offering can help bring about those outcomes. Thompson shared some general thoughts about the data that's coming out in the near future.
"You’ll start to see in the coming year or so our clinical data being published," Thompson said. "The clinical data results are jaw slackening, they are unbelievable from my perspective. They really are better than we might have expected. I think we were pretty convinced about the hypothesis that we were running, which is that human beings in closed loop systems do much better than human beings in open loop systems, but they are really good."
Thompson said he hopes getting his company's various study results out there over the course of the next year will help show how broadly applicable Proteus' digital offerings are -- how big his company's opportunity is.
"You discharge people in their 80s into community settings with six or seven medications to take everyday and you expect them to actually figure out how to do that, and they can’t. Then we’re surprised," Thompson said. "This is an easy design challenge to embrace and for the first time ever we have this tool in everybody’s pocket to solve for it. So the clinical results are important because they will prove some clinical outcomes, but we really hope they will also help people start to embrace the generality of the idea."