Biofourmis, a rapidly growing digital therapeutics venture has entered into a research partnership with Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI). The research CERSI will leverage the BiovitalsHF™ for a study of patients with heart failure to monitor functional capacity and quality of life to determine if the greater emphasis should be placed on these measures in the digital approval process.

TrialSite News breaks down the activities and players for this emerging collaboration.

What is the CERSI?

The Yale-Mayo CERSI is a joint effort between Yale University, Mayo Clinic and the U.S. Food and Drug Administration (FDA). CERSIs are collaborations between FDA and academic medical centers to advance regulatory science through innovative research, training, and scientific exchanges.

What is the Challenge out in the Market?

Heart failure afflicts approximately 6.5 million patients in the United States and 26 million worldwide. The result—substantial mortality and morbidity not to mention major effects on quality of life.

FDA Draft Guidance

The FDA recently produced draft guidance, Treatment for Heart Failure, Endpoints for Drug Development Guidance for Industry, that an effect on symptoms or physical function, without a favorable effect on survival or risk of hospitalization, can be a basis for approving drugs to treat heart failure. The FDA has two purposes with this guidance including 1) to make it clear that an effect on symptoms or physical function, without a favorable effect on survival or risk of hospitalization, can be a basis for approving drugs to treat heart failure; and 2) to provide recommendations to sponsors on the need to assess the mortality effects of drugs under development to treat heart failure.

Joint Project: Why BioFourmis?

Biofourmis develops a mobile platform called BiovitalsHF which will be leveraged by study participants (who are experiencing heart failure) to monitor functional capacity and quality of life to see if the greater emphasis should be placed on these measures in the drug approval process.

CEO Singh Rajput noted, “This joint project has the potential to advance the science of clinical trial design.” Rajput continued “Ultimately, this study could open the door for regulatory agencies to consider including patient-centric endpoints in the drug approval process—which could potentially speed the regulatory approval process.”

How will BioVitalsHF capture and analyze patient-centric endpoints for the study?

Biofourmis will join with Yale-Mayo CERSI to conduct a multicenter study beginning in August 2019 of recently discharged patients with heart failure, who will be screened and then monitored at home for 60 days.

Patients will be monitored using the BiovitalsHF, which is a sensor-agnostic mobile health platform compatible with leading clinically validated, FDA cleared, and medical CE-marked wearable biosensors. BiovitalsHF captures raw biosensor data and uses advanced machine learning to derive dozens of physiology biomarkers and is able to detect heart failure decompensation using multi-variate physiology analytics, weeks in advance.

Real-World Settings

This study, set in real-world settings, will use two wearable biosensors: a medical-grade device called Everion and the consumer wearable smartwatch Apple Watch Series 4. Apart from using the BiovitalsHF patient-facing companion app for synching physiology data from sensors, it will be used to capture electronic patient record outcomes (ePROs) such as medication adherence, symptoms, the Kansas City Cardiomyopathy Questionnaire (KCCQ) responses, and the guided mobile-based 2-minute-step-test.

Study Goal

The primary study goal will be to measure the correlation between physiology and actigraphy biomarkers with clinical endpoints such as lab results, the KCCQ, and the six-minute walk test (6MWT). The data also will be used to assess medication adherence, dose changes and percentage of patients on target dosages of Guideline Directed Heart Failure Therapies.

The group effort here fundamentally understands that clinical trial design increasingly becomes influenced by the drive to encourage patient engagement and the pursuit for improved quality of life. Biofourmis was selected in part because they offer a bundled solution that includes A) user experience B) data analytic capabilities and C) vendor-agnostic sensor capability with a goal of establishing new patient-centric endpoints for clinical trials with this focus on heart failure.

Principal Investigator Comment

Nilay Shah, Ph.D., Principal Investigator with the Yale-Mayo Clinic CERSI stated: “Biofourmis is a leader in the emerging field of digital therapeutics, and we are thrilled to be partnering with them on this important study.” Shah continued “ This study will not only advance science but will also provide insights to the FDA on how these measures can be used as alternative trial endpoints.”

About Biofourmis

A fast-growing digital therapeutics venture involved with the discovery, development, and delivery of clinically validated software-based therapeutics to provide better outcomes for patients, advanced tools for clinicians to deliver personalized care, and cost-effective solutions for payers. 

Founded in 2015, they have raised over $40 million in venture capital financing. They employ approximately 50 and TrialSite News estimates revenues of between $5 to $7.5 million.

About Yale-Mayo CERSI

The Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) is a joint effort involving the two universities and the FDA to create infrastructure for regulatory science knowledge generation, conduct research to address key gaps in knowledge, and develop tools to support regulatory decision-making and the overall mission of the FDA. CERSI leadership includes:

Joseph Ross, MD, MHS, Associate Professor of Medicine (General Medicine)

Nilay Shah, Ph.D., Associate Professor of Health Services Research

Source: PRNewswire

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