Could Data from Smart Devices Tell Us if a Drug Is Working?

The Michael J. Fox Foundation is uniting two of its longtime partners, Cynapsus Therapeutics and Intel Corporation, in a pilot incorporating wearable devices and "big data" approaches into a clinical trial of a drug that may help patients return to "on" (when symptoms are well managed) from an "off" state when medications stop working.

Cynapsus is in Phase III testing – the final stage before applying for FDA approval – of its thin-film, under-the-tongue strip of apomorphine for "off" rescue. MJFF funded Phases I and II. Read more about the drug and its potential for people with Parkinson's disease (PD).

In parallel to supporting the development of new therapies, MJFF works to speed research by improving the processes and systems we use to understand this disease and test new treatments. Toward that goal, in August 2014 we launched an ongoing data science partnership with Intel to develop platforms for the storage of large volumes of patient-generated data and algorithms to glean insights from this data. Read more on our partnership with Intel.

This latest announcement unites these partners to investigate how clinical trials can use "big data" analysis to learn more about PD and measure the impact of therapies.

A subset of volunteers in the Phase III Cynapsus safety study (there is a separate Phase III efficacy study) will take part in the data analytics sub-study. Through a wearable device and the Fox Insight smartphone application (developed by MJFF and Intel), participants will contribute data on movement and medication effect. The data will be securely collected, de-identified and evaluated by Intel using advanced analytics, then stored in a cloud platform that will allow researchers to potentially gain insights into Parkinson's disease, "off" episodes, and the efficacy of the Cynapsus drug (called APL-130277).

This is a proof-of-concept study testing feasibility and utility. Is it possible to capture this data easily? What can we learn from its analysis?

"Clinical studies are the most expensive and time-consuming stages of drug development. Data science approaches hold the potential to accelerate the pace of progress by allowing drug developers to objectively gather and analyze unprecedented volumes of data and more quickly reveal insights about a potential new treatment. We're optimistic about the potential of this technology to help speed breakthroughs patients need," said MJFF CEO Todd Sherer, PhD.

Albert Agro, PhD, chief medical officer of Cynapsus, said, "The data analytics capabilities enabled by Intel and The Michael J. Fox Foundation will allow us to better evaluate how APL-130277 is helping patients. As our Phase 3 clinical trials progress and we move toward gaining FDA approval of APL-130277, we plan to work closely with Intel and The Michael J. Fox Foundation to use this technology to improve the lives of patients with Parkinson's disease."

Patients interested in participating in Parkinson's clinical trials such as Cynapsus' ongoing APL-130277 Phase III efficacy and safety studies or other technology-enabled studies can register with MJFF's online study matching tool Fox Trial Finder at www.foxtrialfinder.org.

Read more about this news in the Financial Times.

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