Eisai Joins REMAP-COVID Trial to Evaluate Eritoran as Investigational Immunomodulatory Therapy for Hospitalized COVID-19 Patients
The University of Pittsburgh Medical Center
The University of Pittsburgh Medical Center (UPMC), founded in 1893, is located in Pittsburgh, Pennsylvania. It employs over 43,000 staff members, including 2,300 physicians, and accepts 1,300 residents annually. With a total of 3,350 hospital beds, UPMC records 167,000 inpatient admissions, 3 million outpatient visits, 400,000 emergency department visits, and more than 130,000 surgical procedures each year. As the world’s largest organ transplant center, UPMC has performed over 12,000 organ transplant surgeries to date. The University of Pittsburgh Medical Center is currently ranked among the best hospitals in the United States.
Eisai
Pharmaceutical Product R&D and Manufacturer
Tokyo, July 8, 2020 /PRNewswire/ --On July 1, 2020, the Global Adaptive Research Alliance (Los Angeles, California) partnered with UPMC (University of Pittsburgh Medical Center) and Eisai Co., Ltd. (headquartered in Tokyo; CEO: Haruo Naito; “Eisai”). Eisai recently announced its participation in the REMAP-COVID initiative, a substudy of REMAP-CAP (a randomized, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia), to evaluate multiple therapeutic interventions for hospitalized patients with COVID-19.
Eritoran (an investigational TLR4 antagonist discovered and developed by Eisai) has been selected as the first investigational immunomodulatory therapy to be evaluated in the moderate-disease cohort of the REMAP-COVID trial. The trial will be conducted across the multi-hospital UPMC healthcare system and other medical centers in the United States, with other global sites across the international trial network, including those in Japan, to follow shortly. Previously, the safety of eritoran was demonstrated in a large-scale Phase 3 randomized trial in sepsis; the drug aims to inhibit the excessive production and release of various pro-inflammatory mediators (“cytokine storm”), thereby protecting the lungs and other organs of COVID-19 patients from damage.
“We are pleased to partner with Eisai and to evaluate this promising intervention in a clinical trial,” said Christopher Seymour, MD, MSc, Associate Professor of Medicine in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Pittsburgh and UPMC, and the U.S. Principal Investigator for the REMAP-CAP: COVID study. “By leveraging an adaptive design rather than traditional trial methods, we are more likely to obtain answers more quickly while ensuring patient safety to the greatest extent possible. REMAP-COVID is a premier study designed to identify potential treatments for COVID-19 as safely, rapidly, and effectively as possible.”
“Eisai is honored to participate in this collaborative initiative to combat the unprecedented COVID-19 pandemic. We are pleased to learn that independent studies, as well as combination studies with other drugs, will be conducted on our investigational immunomodulatory therapeutic TLR4 antagonist, eritoran, to evaluate its efficacy in hospitalized patients with COVID-19,” said Lynn Kramer, M.D., Chief Medical Officer of Eisai’s Neurology Business Group. “As part of our mission to contribute to human health, the company remains committed to making a difference for patients, their families, and healthcare professionals worldwide.”
The REMAP-CAP trial was designed to identify optimal treatment strategies for severe pneumonia in both non-pandemic and pandemic settings. At the onset of the COVID-19 outbreak, REMAP-CAP rapidly transitioned to its pandemic mode (the REMAP-COVID substudy), aligning with its original intent by incorporating additional potential therapies specifically targeting COVID-19 and expanding enrollment to include patients with COVID-19. This trial is a multicenter, randomized, platform study comparing standard care against multiple active comparator arms.
The primary endpoint of the REMAP-COVID substudy is the number of days free from organ failure within a 21-day observation period. Eritoran will be administered to hospitalized patients for evaluation within the immunomodulation domain of REMAP-COVID.
REMAP-CAP is led by globally renowned critical care researchers and experts in pandemics, infectious disease outbreaks, virology, immunology, emergency medicine, and Bayesian statistics. The trial has enrolled more than 1,100 patients across 218 sites in North America, Europe, Australia, and New Zealand. This important study is conducted in collaboration with Berry Consultants, a leader in the statistical design of adaptive platform trials, and is supported by governments and non-profit organizations worldwide. Recently, the Breast Cancer Research Foundation committed $1 million to help launch U.S. trial sites, leveraging the innovative trial infrastructure established over the long term by the Breast Cancer Translational Therapeutics Consortium.
“The REMAP study strategy for COVID-19 provides a platform to build upon existing knowledge while rapidly assessing the safety and efficacy of multiple investigational treatments against the virus, thereby enabling us to learn as much as possible from COVID-19 clinical trials,” explained Dr. Mark McClellan, MD, Robert J. Margolis Professor of Business, Medicine, and Policy, and Founding Director of the Duke-Margolis Center for Health Policy at Duke University.
“GCAR is honored to participate in this global collaborative initiative, serving as the U.S. trial host for REMAP-CAP: COVID, and jointly with the University of Pittsburgh as the U.S. Regional Coordinating Center,” shared Dr. Meredith Buxton, CEO of GCAR and MPH. “We are pleased to leverage our extensive experience in conducting platform trials to support this critical effort. By collaborating with key partners across academia, industry, and philanthropy, we strive to identify improved treatment regimens for patients with COVID-19.”
For more information about REMAP-CAP and the REMAP-COVID ancillary studies, please visitwww.remapcap.org, and follow @remap_cap