Takeda Pharmaceutical and Koneksa Health, an early stage company focused on the integration of real world data into clinical research, have announced an ongoing strategic collaboration to utilize new digital health tools in clinical trials.

Using Koneksa’s technology data platform, Takeda is integrating biosensor and wearable technology in several of its early stage clinical studies. Koneksa’s technology enables the remote collection of data measures that were previously difficult to obtain, such as patients’ continuous vital signs, activity levels and sleep metrics. These initial clinical studies will also facilitate a performance qualification of digital health tools relative to traditional in-clinic, gold-standard assessments.

Takeda’s goal in pursuing this technology is to empower the development of “digital biomarkers” that may improve decision-making and, eventually, establish novel endpoints that will advance the assessment of patients’ functional status in their natural settings.

“Working with Koneksa enables us to take advantage of technologies and expertise that provide access to novel data streams and make our clinical trials more patient-centric. Koneksa’s end-to-end solution allows us to collect this data in our studies using Koneksa’s sensors and devices,” said Elena Izmailova, Ph.D., senior director, Novel Data Streams and Devices, at Takeda. “Takeda’s commitment to digital health involves working with an ecosystem of external partners that, like Koneksa, have a focus on both rigor and innovation.”

“Takeda has an exciting early pipeline of programs as well as a deep commitment to ensuring that its therapies have the most meaningful impact to patients," said Chris Benko, chief executive officer of Koneksa. “This partnership provides Koneksa the opportunity to support the development of exciting medicines while broadening our bench of clinically validated sensor and device integrations.”

Wearable technology and remote, electronic patient data capture are valuable tools for fortifying research with a sound foundational framework. The study of disease progression or treatment effects, along with the safety profile of new drugs, necessitates new forms of data collection beyond the traditional patient-investigator rapport. Koneksa’s method of data integration is designed to enhance the ability to capture patients’ symptoms, interactions and day-to-day activities.