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Scouting Report-Koneksa: Validating Biomarkers for Decentralized Clinical Trials

The Driver:

Koneksa Health recently raised $45 million series C funding bringing their total capital raised to $70.6M. As noted by the company, Koneksa Health is a healthcare data analytics company that develops end-to-end solutions for remotely collected clinical data to help produce more meaningful data in clinical research by collecting it in real-world settings. Koneksa is founded by Chris Benko, the former VP of Strategic Planning at Merck. The fundraising round was led by AyurMaya with participation from Takeda Ventures, Velocity Capital, McKesson Ventures, Merck Global Health Innovation Fund, Novartis (dRx Capital) Spring Mountain Capital, and Waterline Ventures. The funds will be used to collect more data to support their digital biomarker pipeline (ex: to validate the assessments that the app offers) and to develop a “self-service” platform to allow new users to combine data from different sources into one stored dashboard.

Key Takeaways:

  • In one study, Koneksa was able to reduce the number of patients for biomarker validation by 82%

  • Studies show approximately half of clinical study participants drop out of trials before study completion and only 5% of patients participate in clinical trials

  • Koneksa is working to show in-home patient data can provide clinical insight, demonstrating in one study that for every 1,000 steps walked, there was a 26% reduction in hospitalization risk faced by the patients.

  • Koneksa Health has worked with clinical trials at 700 sites.

The Story:

Chris Benko was responsible for incubating Koneksa Health as part of the Merck Global Health Innovation Fund which he ran, It was his desire to help capture health-related data that can be used to find novel treatments for diseases ranging from neurological diseases to respiratory conditions. He founded Koneksa to develop healthcare software to record patient-generated health data using digital biomarkers, which Rock Health defines as “consumer-generated physiological and behavioral measures collected through connected digital tools.” As Benko noted when the company did its series B fundraising, “digital biomarkers have as much potential to transform the development of new medicines as the molecular, imaging, and fluid biomarkers of the last two decades.” With the use of the Koneksa app, information can be recorded from anywhere, even the patients’ home. The company partners with biotech and pharmaceutical companies to develop biomarkers that can be used clinically to treat patients with different diseases. At the moment, the majority of company capital comes from investors like the ones mentioned earlier.

The Differentiators:

Koneksa’s software gathers a variety of data through questionnaires about mood, daily activities, symptoms, and combines it with clinical evaluation like movement tests. The end goal is to develop a drug or treatment for several different kinds of health conditions. While Koneksa’s competitors like Songe use tools like vocal screening for spirometry and mental illness analysis, as noted in Tech Crunch, Koneksa is working to turn analog testing scales into digital ones. For example, as noted in Tech Crunch, when testing for Parkinson’s Disease in order to quantify a tremor, “a physician might ask a patient to stretch out an arm and flip their palm upwards and downwards as fast as they can” and watch for subtle changes in speed or shape of that movement. By contrast, “Koneksa’s approach, asks that the patient hold their phone, and perform the same motion using the phone’s accelerometer and gyroscope, record those changes and transmit data to the company’s platform”, which can then be evaluated and “scored” against others by Koneksa’s algorithm. In addition, Koneksa is also focusing on how digital biomarkers can be used to increase the amount of real-world data collected in the trial process and then using this data to help get products to market more rapidly. For example, in a study of asthma patients, Koneksa was able to demonstrate that data collected from at-home devices were comparable to clinical devices but also enabled more frequent data collection requiring fewer participants to collect the required data. That not only makes it cheaper for trial sponsors but more convenient for patients.

The Big Picture:

Digital biomarkers have significant potential to increase the quality and frequency of data collection for drug discovery going forward, As a result, data collection for many types of trials can go from collecting infrequent, discrete data sets to essentially continuous data sets, empowering improved data quality and even predictive analytics. There is also a positive outlook on user friendliness among patients. In addition, this type of platform may create entirely new sets of valuable health data to help speed the regulatory approval process and boost the efficiency of clinical trials. The more usage this technology gets, the more effective it should be in further research. The application of such real-world devices will also make it easier and more convenient for many groups who were not able to access the current clinical trial system to become more involved and hopefully better represented. However, challenges may arise with such platforms for those who are frail or elderly and may not be technologically literate or for those who may lack access to broadband. While near-term these issues may be addressed by devices that can store and forward the data, over time a more permanent solution will need to be developed.


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