Litmus Health, a company helping pharma companies use wearable devices to improve the efficiency of Phase I and II drug trials, is coming out of public beta and announcing a trial with the University of Chicago testing the effects of activity, sleep, and diet on Inflammatory Bowel Disease (IBD) patients. The trial is funded via a grant from Takeda Pharmaeuticals.

"I see so many patients filling out forms or filling out online surveys that are very much just a carbon copy replica of a paper survey that still has to be typed up by hand," Sam Volchenboum, chief science officer of Litmus, and director of the Center for Research Informatics at the University of Chicago, told MobiHealthNews. "So the way that we collect data was atrocious, and it seemed to be such an opportunity to improve things based on all the devices and different ways of collecting data. We use these devices to measure the quality of a patient’s life, whether it’s how much pain they’re having or how well they sleep or what their activity is. And asking somebody how they slept for the last month in a once-a-month survey is just a terrible way to collect data." 

Instead, Litmus lets patients collect data via consumer devices and pair those devices to their own smartphones or tablets.

"We’re focused on being agnostic to the devices because we know people are going to have their own devices, we know pharma are going to want to use whatever devices they’re most comfortable with, so we built the platform around being able to use different devices, different phones, different architectures, that we can let people collect the data the way they should collect data," Volchenboum said. "Through phone surveys, through Fitbit, through Garmin, whatever else they want to wear and then we take the data, we integrate it, we correlate it with more standard metrics, and then we report that data back to the sponsors so they have a real vision of how well the patient is sleeping or how well they’re walking or how much pain they’re having."

While several companies are creating a data layer for hospital trials, Litmus Health is specifically targeted at pharma companies at a crucial point in their drug development cycle.

"The business proposition here is that pharma’s broken in some ways," CEO Daphne Kis told MobiHealthNews. "The clinical trial process is analgous to the VC world where one in 10 or 15 hits pays for all the other failures. That as a longterm model is not really a business model that works. So what we are seeing is, part of the interest from pharma is that tools like ours that are data-driven provide pharma with help in making drug development decisions. We’re specifically focusing on phase I and II before the hockey stick of Phases III and IV in the hopes that it will have an impact in the business decision of whether to go ahead with drug development, based on having better, more correlated data to make those decisions."

Pharma companies need a platform just for them, Volchenboum said, because of the regulatory rigor the FDA requires for drug development trials.

"Before we came along the sponsors have just been too gunshy about using these devices," he said. "Something we bring is a tight integration with all of the requirements that are necessary for trials. We’ve really committed ourselves to being HIPAA compliant and being compliant for FDA submission. And this has been a real boon for us because the sponsors are very much caught up in making sure any data they collect is going to be acceptable to the FDA. So I think this is really positioning us well with the different pharma companies"

The University of Chicago trial, led by Dr. David Rubin, is a study using Fitbits to study the effects of activity, sleep, and diet on IBD patients. It's starting with 100 patients but the researchers have plans to expand that cohort to around 600. IBD patients are a group that already tend towards self-monitoring, Kis said.

"People are trying all day long to document correlations between their chronic condition what they eat, and their sleep, or their activity," she said. "People have been trying to do this on their own behalf whether it’s through little diaries or charts that they keep and now we have the ability to use these tools to actually figure it out, both with their active participation and just to passively collect this type of data."

Litmus Health is self-funded so far, though the company does plan to raise an initial round of funding soon.