Rating symptoms on a numerical scale sounds easy, but it can be more difficult than it seems. How much did it hurt when you stubbed your toe? Was it a two out of 10? A four? How often do you wake up at night? Two, three times? Regularly? Hardly ever?
These imprecise, self-reported scales can be found throughout medicine, even in relation to diseases where the stakes are higher than a bruised fingernail. koneksa, founded in 2013, is focused on discovering and validating clinical biomarkers. That process begins with looking to convert those analog scales to digital and improving them in the process.
koneksa has developed software that works with a variety of devices, from wearable spirometers to iPhones and Apple Watch. These devices capture data, from which the software extracts clinically valuable information and organizes it for review by pharmaceutical companies or healthcare providers conducting clinical trials.
Thanks to several studies and work with clinical trials in more than 700 locations, koneksa announces an increase in Serie C of 45 million dollars. The company has been comparatively modest so far, raising $4 million in Series A and seed funding, and a $16 million Series B.
This round will be part of a larger push to usher in what CMO John Wagner calls a "tipping point" in the world of digital biomarkers. (Wagner arrives at koneksa after working at Cynga, Merck, Takeda and Forestite Capital. He also edited the journal Clinical and Translational Science).
“It is well known that the more measurements you take, the more precision you will get and the more certainty a clinical trial can have. Which makes the analysis faster and more efficient,” said Wagner. “I like to think of it as the difference between a still photo and a video. A still photo is great, but a video can tell the whole story. This is how we think of digital biomarkers: they tell the whole story compared to traditional biomarkers.”
Koneksa Tremor Assessment Tool for Parkinson's.
How does koneksa convert analog scales to digital? Parkinson's offers a clear example. A common, but imperfect, index used to assess Parkinson's patients is called the Unified Parkinson's Disease Rating Scale. It is a multi-part exam that combines questionnaires about mood, daily life, and symptoms, with a clinical evaluation, such as movement tests.
To quantify a tremor, a doctor might ask a patient to stretch out one arm, and turn their palm up and down as fast as they can. Meanwhile, the doctor watches for subtle changes in the speed or shape of that movement. The approach of koneksa, instead, has the patient hold their phone and perform the same motion. The phone's accelerometer and gyroscope record these changes and transmit data to the company's platform.
After that, the company's algorithms "rate" that tremor, similar to how a doctor might assign a score after an exam.
"The potential for these sensors to give a much more granular and, I use this word carefully, a more objective reading of a man's tremor - there is tremendous potential in what our technology can do," CEO Chris Benko told TechCrunch. .
The idea of modernizing analog patient monitoring techniques with technology has already attracted many companies. koneksa it's improving that service, but it's not just looking at software. It is about proving the entire thesis of the reliability of digital biomarkers, if not improving them in the process.
A phone can detect small hand movements that a doctor might miss. But do those hand movements really represent tremors? And do these digitized tests really tell doctors anything about how patients will fare in the future?
To know the answers to those questions, digital biomarkers need to be clinically validated. Without that validation, such tools are ultimately useless in clinical trials.
“We wanted to focus on the control issues that are important to bringing new therapies to patients on the market, and then figure out how to do the scientific validation that shows these technological tools are better than or equivalent to what's out there. We have to do it at the level of the world's leading pharmaceutical companies," Benko said.
That validation is the current approach of koneksa. The company has been able to show that measurements taken at home correlate with tests performed in a clinic.
A study with 12 patients with asthma, for example, showed that readings from a home spirometer were comparable to those taken in a clinic. The patients made some mistakes, Benko said, but because they were able to take the test more often, the researchers ended up with a lot more data to work with.
A typical asthma clinical trial, the study notes, would need to enroll about 100 patients to get a meaningful result. Using home testing, the authors of this report suggest they could get the same results with just 18 people. "That's what's economically interesting for the drug company," Benko said. "But for patients, they just say it's more convenient and it's more real."
The company has also been able to make a compelling case that data from patients at home can provide clinically meaningful information. For example, the company conducted a study in 66 patients with brain and throat cancer, where they used wearable devices to measure the number of daily steps.
For every 1000 steps walked, the study found a 26% reduction in patients' risk of hospitalization. However, as Benko pointed out, it was their activity on the weekends (ie, the patients' own self-selected movement) that revealed this statistic, not the schedules of movement due to weekday responsibilities.
That study was presented at the 2021 American Society of Clinical Oncology meeting, but never got published in a journal.
Even so, the one who ultimately decides on clinical validity, at least when it comes to drug development, in the case of the United States, is the FDA. The next step of koneksa it will be to demonstrate that these biomarkers are reliable enough to be integrated into the regulatory decision-making process.
“What we are preparing right now are property studies of koneksa or collaboration of koneksa with academics to drive clinical validation,” said Wagner.
Full range of sizes koneksa
Regarding the capital raised in Series C, koneksa it has two goals.
The first is to add the evidence that supports your digital biomarker stream. In the past, the company has worked with its pharmaceutical partners to search for and validate digital biomarkers. Getting validation before these associations will allow koneksa launch new programs much faster.
The second piece is a launch of what Benko calls a "self-service" platform. This self-service platform allows new partners to combine data from multiple devices and wearables in the same place and organize it in a common space.
“We recognize that the software's ability to integrate such chaos of device data in a clinical trial environment is unique. There is no other asset like it on the market. So why should we monitor it for every possible use? We want to be able to open it up to say, 'we can license this platform to you'."
Although these two objectives are operationally distinct, they have a goal Similary. koneksa seeks to convert its platform and digital biomarkers into a turnkey solution.
This round was led by AyurMaya, a fund managed by Matrix Capital Management, with the participation of Takeda Ventures and Velosity Capital. Previous investors McKesson Ventures, Merck Global Health Innovation Fund, Novartis (dRx Capital), Spring Mountain Capital and Waterline Ventures also participated in the round.
