Home > News > Latest > FDA contributes to hunt for new heart failure endpoints

FDA contributes to hunt for new heart failure endpoints

A collaboration involving the FDA is set to evaluate new endpoints for heart failure clinical trials. The partners will use wearable devices to assess how heart failure patients function and feel after being discharged from hospitals. Working as part of the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI), the FDA has identified the need for alternative heart failure endpoints. Improving mortality and reducing hospitalizations are gold-standard endpoints for clinical trials, but attempts to demonstrate the efficacy of drugs against those yardsticks are confounded by factors including the variability of the patient population. A who’s who of major drug developers including Abbott, Bayer, Genentech, Novartis and Merck have come unstuck when trying to show safety and efficacy in phase 2 and 3 heart failure trials over the years, resulting in significant, ongoing unmet medical needs. Yet, mortality and hospitalizations are far from the only important things to heart failure patients. As these patients have substantially reduced functional capacity and quality of life, there is scope for drugs to demonstrate their worth in the population in other ways, provided researchers can gather accurate, reliable data to measure these changes. Recognizing that, CERSI, in collaboration with Biofourmis, plans to assess the use of wearable devices to capture data on endpoints that are complementary to the mortality and hospitalization measures in use today. Starting next month, the partners will track heart failure patients for 60 days after they are discharged using Apple Watch and Biovotion’s Everion wearable. These devices will feed data into Biofourmis' BiovitalsHF, a platform that crunches sensor data to derive physiology biomarkers and detect heart failure decompensation. Biofourmis will also provide a smartphone app that enables the capture of electronic patient-reported outcomes and helps patients perform a two-minute step test.

Spotlight

Other News

Medical

Personalis and ClearNote Health Announce Partnership to Advance Epigenomic Technology

Personalis, Inc. | February 05, 2024

Personalis, Inc. a leader in advanced genomics for cancer, and ClearNote Health, Inc., a pioneer in epigenomic technologies, today unveiled an alliance through which Personalis will expand its pharmaceutical service offerings by distributing ClearNote’s cutting-edge epigenomic 5-hydroxymethylcytosine (5hmC) platform. “We have built a unique pharma channel based on our industry-leading tissue and MRD assays and ClearNote Health’s blood-based epigenomic approach is complementary to our offering as it helps our customers deepen their understanding of a patient’s response to immunotherapies,” said Chris Hall, CEO and President of Personalis. “Commercial partnerships such as this broaden our portfolio and are expected to appeal to a wide range of biopharma customers and accelerate our revenue growth.” Echoing this sentiment, Dave Mullarkey, CEO of ClearNote Health, remarked, “Partnering with Personalis presents an excellent opportunity to bring our 5hmC technology to the forefront of cancer research. This alliance is a testament to the synergy between our two companies, enabling us to expand our reach and significantly impact the biopharmaceutical industry. Together, we can accelerate the development of personalized therapies and make a real difference in the lives of patients.” ClearNote Health’s Epigenomics Platform represents a groundbreaking advance in cancer detection, offering real-time insights into disease-specific pathways. By tracking changes in 5hmC levels coupled with artificial intelligence-based analytical methods, the platform can detect cancer earlier, monitor disease progression, understand mechanisms of resistance, and identify promising drug targets and biomarkers. These insights are invaluable for optimizing drug development programs and delivering more effective treatments to patients. The Epigenomics Platform identifies changes in gene activation and gene regulation by labeling specific changes in the 5hmC landscape from plasma-derived cell-free DNA. This rich biological information, as part of clinical trials, enables the monitoring of cancer therapies in real time and contributes to an understanding of drug resistance mechanisms. The partnership marks a pivotal moment in cancer research, leveraging the strengths of both companies to offer unparalleled solutions in the biopharmaceutical industry. About ClearNote Heath, Inc. ClearNote Health is a cancer detection company focused on enabling people at risk for high-mortality cancers to live longer, healthier lives. Utilizing a standard blood draw, the company applies its proprietary epigenomic platform, combining biology and artificial intelligence, to identify DNA-based changes in biology as cancer develops. With lead programs in non-invasive early detection of pancreatic and ovarian cancers in patients at the highest risk for these diseases, ClearNote Health identifies cancers before they progress and when patients are most likely to benefit from treatment. ClearNote Health’s first commercially available test is the Avantect™ Pancreatic Cancer Test, which detects the presence of pancreatic cancer signals in patients at high risk of the disease, including those recently diagnosed with Type 2 diabetes. ClearNote Health is headquartered in San Diego, with additional presence in the San Francisco Bay area and internationally. The company’s CLIA- and CAP-accredited laboratory is located in San Diego, Calif. About Personalis, Inc. At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest time points, enable the selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.