Score signs on a numerical scale appears simple, however it may be tougher than it seems. How a lot did it damage while you stubbed your toe? Was it a two out of 10? A 4? How usually do you get up at night time? Twice, 3 times? Commonly? Not often?
These imprecise, self-reported scales may be discovered all through medication, even regarding ailments the place the stakes are increased than a bruised toenail. Koneksa, founded in 2013, is working towards discovering and validating medical biomarkers. That course of begins by seeking to flip these analog scales digital — and enhance them within the course of.
Koneksa has developed a software program suite that works with a wide range of gadgets, from moveable spirometers to iPhones and Apple Watches. These gadgets seize knowledge, from which software program gleans clinically helpful alerts and organizes them for evaluation by drug firms or healthcare suppliers working medical trials.
On the again of a number of research, and work with medical trials at over 700 websites, Koneksa is saying a Sequence C elevate of $45 million. The corporate has been comparatively frugal up to now, elevating $4 million in Sequence A and seed funding, and a $16 million Sequence B.
This spherical can be a part of an enormous push to usher in what CMO John Wagner calls an “inflection level” within the digital biomarker world. (Wagner involves Koneksa after stints at Cynga, Merck, Takeda and Foresite Capital. He additionally edited the journal Medical and Translational Science.)
“It’s well-known that the extra measurements you’re taking, the extra accuracy you get, and the extra energy a medical trial can have. That makes [the trial] smaller, sooner and extra environment friendly,” Wagner advised TechCrunch. “I like to consider it because the distinction between a nonetheless picture and a video. A nonetheless picture is nice, however a video is ready to inform the entire story. That’s how we consider digital biomarkers: they inform the entire story in comparison with conventional biomarkers.”
How does Koneksa go about turning analog scales into digital ones? Parkinson’s provides a transparent instance. A typical, but imperfect, index used to judge Parkinson’s sufferers is named the Unified Parkinson’s Illness Score Scale — it’s a multi-part examination that mixes questionnaires about temper, day by day life and signs, with medical analysis, like motion exams.
To quantify a tremor, a doctor may ask a affected person to stretch out an arm, and flip their palm upwards and downwards as quick as they’ll. In the meantime, the clinician watches for refined adjustments in velocity or form of that motion. Koneksa’s method, as a substitute, has that affected person maintain their cellphone, and carry out the identical movement. The cellphone’s accelerometer and gyroscope file these adjustments and transmit knowledge to the corporate’s platform.
Behind the scenes, the corporate’s algorithms “rating” that tremor, much like how a doctor may assign a rating after an examination.
“The potential of those sensors to provide is a much more granular and, I take advantage of this phrase rigorously, a extra goal, studying of a person’s tremor — there’s large potential in what our expertise can do,” CEO Chris Benko advised TechCrunch.
The thought of revamping analog patient monitoring techniques with tech has already attracted a number of firms. Koneksa is definitely taking part in in that world, however it doesn’t have its sights set on simply software program. It’s going after proving the entire thesis of digital biomarker reliability — if not supremacy.
It’s nice if a cellphone can decide up tiny hand actions that a health care provider may miss. However do these hand actions truly signify tremors? And, do these digitized exams truly inform medical doctors something about how sufferers will fare in a while?
To know the solutions to these questions, digital biomarkers must be clinically validated. With out that validation, such instruments are in the end ineffective in medical trials.
“We needed to give attention to gatekeeping issues which might be necessary for getting new therapies to marketplace for sufferers, after which determine the way to do the scientific validation that exhibits these expertise instruments are higher or equal to what’s on the market. We’ve got to try this to the usual of the world’s main drug firms,” Benko mentioned.
That validation is Koneksa’s present focus. In that regard, the corporate has been capable of present that at-home measures do correlate with exams performed in a clinic.
One study on 12 bronchial asthma sufferers, for instance, confirmed that readouts from an at-home spirometer have been akin to these performed in a clinic. The sufferers did make some errors, famous Benko, however as a result of they have been capable of carry out the take a look at extra usually, the investigators ended up with way more knowledge to work with.
A typical bronchial asthma medical trial, the research notes, would want to enroll about 100 sufferers to get a significant consequence. Utilizing the at-home exams, the authors counsel they might get the identical outcomes with simply 18 individuals. “That’s what’s economically fascinating to the drug firm,” mentioned Benko. “However for the sufferers, they’re merely saying, it’s extra handy, and it’s extra actual world.”
The corporate has additionally been capable of make a compelling case that in-home affected person knowledge could yield clinically significant perception. As an example, the corporate has run one research on 66 sufferers with head and neck most cancers, the place they used wearable gadgets to measure day by day step counts.
For each 1,000 steps walked, the research discovered a 26% discount in hospitalization danger confronted by the sufferers. Nevertheless, as Benko famous, it was their exercise on the weekends (i.e. motion that sufferers selected themselves) that exposed this statistic, not the motion schedules they adhered to due to weekday obligations.
That study was offered on the 2021 American Society of Medical Oncology assembly, however was not printed in a journal.
Nonetheless, the last word decider of medical validity, at the least in terms of growing medicine, is the FDA. The subsequent step for Koneksa can be to show these biomarkers are dependable sufficient to combine them into the regulatory choice making course of.
“What we’re teeing up proper now are Koneksa-owned or Koneksa-collaboration research with lecturers with a view to push the envelope on medical validation,” mentioned Wagner.
As for the Sequence C milestones, Koneksa has two objectives.
The primary is so as to add to the proof that backs up their digital biomarker pipeline. Previously, the corporate has labored alongside their pharma companions to hunt out digital biomarkers and validate them. Getting the validation performed forward of those partnerships will permit Koneksa to get new applications off the bottom far sooner.
The second piece is a launch of what Benko calls a “self-service” platform. This self-service platform permits new companions to mix knowledge from a number of gadgets and wearables into the identical place, and manage them right into a dashboard.
“We acknowledge that the software program’s capacity to combine that [disparate] machine knowledge in a medical trial setting is exclusive. There isn’t one other asset prefer it available on the market. And so why ought to we management it for each potential use? We would like to have the ability to open it as much as say: ‘hey, we will license this platform to you.’”
Although these two objectives are operationally distinct, they do have the same taste. Koneksa is seeking to flip their digital biomarkers and platform right into a turnkey answer.
This spherical was led by AyurMaya, a fund managed by Matrix Capital Administration, with participation from Takeda Ventures and Velosity Capital. Present traders McKesson Ventures, Merck International Well being Innovation Fund, Novartis (dRx Capital), Spring Mountain Capital and Waterline Ventures additionally participated within the spherical.