Cynapsus Therapeutics Inc. and The Michael J. Fox Foundation for Parkinson’s Research are working together to incorporate wearable device technology and “big data” approaches into Cynapsus’ pivotal Phase 3 clinical study of APL-130277, an under-the-tongue formulation of apomorphine to treat (“OFF”) episodes in Parkinson’s disease patients. The project expands upon MJFF’s ongoing data science partnership with Intel Corporation, launched in August 2014, to develop platforms for the storage of large volumes of patient-generated data and algorithms to amass insights from this data.
As Parkinson’s progresses, the efficacy window of dopamine replacement medication shortens, and patients experience motor fluctuations known as OFF episodes. Apomorphine is a “rescue” therapy, approved in subcutaneous formulation, to quickly bring patients back to “ON.” Cynapsus has been developing APL-130277, its fast acting, easy-to-use sublingual thin film formulation of apomorphine since 2010. While the Michael J. Fox Foundation funded earlier phases of clinical development, neither the Foundation, nor Intel, is funding these APL-130277 Phase 3 studies. Phase 3 results on the safety and efficacy of APL-130277 are expected in 2016.
“Employing wearable technology to collect data in clinical trials has enormous potential to improve our understanding of how drugs and other treatments impact patients living with the debilitating symptoms of this disease,” stated Todd Sherer, Ph.D., chief executive officer of MJFF. “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.”
The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $525 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure.
Participants in the Phase 3 safety study will contribute data on movement and medication effect via a wearable device and the Fox Insight smartphone application (developed jointly by MJFF and Intel). The information will be securely collected, “de-identified” and evaluated 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 APL-130277
“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,” stated Albert Agro, Ph.D., chief medical officer of Cynapsus. “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.”