Decentralized Trials

Greater digital biomarklers adoption in clinical studies as Koneksa and SSI Strategy collaborate

By Ben Hargreaves

- Last updated on GMT

© Getty Images
© Getty Images

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The two partners will pool capabilities to provide an expanded service to their clients, which will see Koneksa provide its digital biomarkers tools and SSI Strategy its expertise in drug development.

SSI Strategy is a life sciences consulting firm that works with biotechs to progress their drug candidates. By partnering with Koneksa, the company gains access to at-home digital solutions that are able to measure biomarkers.

Biomarkers are useful to biotechs because they are able to measure key characteristics that indicate normal biological processes, such as pathogenic processes, or responses to treatments.

Koneksa’s digital biomarker solutions allow research sponsors and clinical sites the ability to aggregate data in real-time from devices, electronic patient reported outcomes (ePROs), patient diaries, and clinical assessment.

In terms of what measurements can be assessed via the technology, Koneksa stated that it allows for at-home spirometry, actigraphy, gait and balance-monitoring tools, and vital-sign monitoring.

Doug Locke, CEO of SSI, outlined that the addition of Koneksa’s tools would allow biotechs to address pre- and post-market evidence requirements at earlier stages of development.

As part of the partnership, SSI will expand Koneksa’s medical strategy division, with the two companies noting that there would be a focus on translational and clinical drug development.

Put simply, the partners state that Koneksa’s clients will gain to medical expertise from SSI, and SSI’s clients will gain access to digital biomarker tools.

“This synergistic partnership is a combination of resources, talent and expertise across two leading science-based organizations with a mission of optimizing and accelerating therapies for patients in need, through greater adoption of digital biomarkers in clinical studies,” said Vik Shah, president and COO of Koneksa.

Koneksa’s client base is made up of contract research organizations (CROs) and decentralized clinical trial (DCT) organizations.

The digital biomarker tools include wearable devices that have multiple sensors, which then provide feedback into the Koneksa platform. The data is captured in real-time and provides actionable insights, making them suitable for CROs organizing trials in a DCT environment.

According to Koneksa, the technology allows for participant compliance status to be measured in real-time.

The company offers solutions across various therapeutic areas, including neuroscience, oncology, and respiratory diseases, among others. Koneksa has already partnered directly with major pharma companies with its biomarker offerings, after signing a deal with Regeneron for respiratory disease, and with Sanofi to develop biomarkers to measure gait in patients with neurological diseases.

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