Eisai, Amgen, and Global Coalition for Adaptive Research Announce First Patient Enrolled in International REMAP-COVID Trial Evaluating Immunomodulatory Therapies

TOKYO, Nov. 6, 2020 /PRNewswire/ --Global SuitabilityThe Global COVID-19 Adaptive Research (GCAR) Alliance, in collaboration with Amgen and Eisai, recently announced the enrollment of the first patient in the REMAP-COVID immunomodulatory therapy study. This study is a substudy of REMAP-CAP (a randomized, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia) and aims to evaluate multiple therapeutic interventions for hospitalized patients with COVID-19. It is currently assessing whether Amgen’s apremilast and Eisai’s investigational drug eritoran can serve as treatment options.

The REMAP-CAP trial was designed to identify optimal treatment strategies for severe pneumonia in both non-pandemic and pandemic settings. In February 2020, during the early outbreak of COVID-19, REMAP-CAP rapidly transitioned to a pandemic mode (the REMAP-COVID sub-study), consistent 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 that evaluates interventions across different pathways or mechanisms of action.

This trial is being conducted at multiple hospitals within the UPMC (University of Pittsburgh Medical Center) health system and at more than 20 other hospitals across the United States. Additional global research centers will be added to the trial network subsequently. The University of Pittsburgh serves as the U.S. Regional Coordinating Center.

“Collaboration with the biopharmaceutical industry facilitates the efficient evaluation of existing targeted therapies, which is critical to understanding treatment patterns in patients with COVID-19,” said Derek Angus, MD, MPH, FRCP, Principal Investigator of REMAP in the United States and Chief Healthcare Innovation Officer at UPMC Health System. “Today’s announcement marks a significant milestone in the collaboration among the biopharmaceutical industry, the scientific community, and academia, aiming to pool collective expertise to jointly evaluate promising treatments for hospitalized patients with COVID-19.”

Amgen’s apremilast is an oral medication that inhibits the activity of phosphodiesterase 4 (PDE4), an enzyme found in inflammatory cells in the human body. By inhibiting PDE4, apremilast modulates the production of pro-inflammatory cytokines and other mediators, thereby potentially helping to alleviate inflammation-related symptoms, signs, and pulmonary manifestations observed in patients with COVID-19. The oral formulation of apremilast has currently been approved in more than 45 countries for the treatment of inflammatory diseases, including moderate-to-severe plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s disease.

“Amgen believes that, based on its mechanism of action, apremilast may help prevent respiratory distress in adult patients with moderate to severe COVID-19,” said David M. Reese, Executive Vice President of Research and Development at Amgen. “We are honored to join REMAP-COVID, a significant innovative initiative leveraging a platform approach that has the potential to rapidly determine whether apremilast can improve health outcomes in hospitalized patients with moderate to severe COVID-19.”

Eritoran is an experimental Toll-like receptor 4 (TLR4) antagonist independently developed by Eisai using natural product organic synthesis technology. It is a structural analog of lipid A, the active pharmacological component of bacterial endotoxin. Favorable safety profiles have been observed across 14 clinical studies, including a large Phase III randomized trial in patients with severe sepsis. The drug is expected to control inflammation and disease progression caused by COVID-19 by inhibiting TLR4 activation; TLR4 serves as the most upstream signaling pathway for the expression of various cytokine genes involved in cytokine storms.

“Eisai is honored to participate in this groundbreaking REMAP-COVID trial. We hope that this study will thoroughly evaluate whether eritoran can improve health outcomes in patients with moderate to severe COVID-19 and yield meaningful conclusions,” said Lynn Kramer, M.D., FAAN, Chief Medical Officer of Eisai’s Neurology Business Group. “As part of our mission to care for human health, the company remains committed to bringing transformative change to patients, their families, and healthcare professionals worldwide.”

GCAR is the U.S. sponsor of REMAP-COVID and is working to engage multiple global pharmaceutical partners in the REMAP-COVID trial.

“GCAR is pleased to leverage our expertise in implementing and overseeing innovative trials to advance this critical work together,” said Dr. Meredith Buxton, CEO of GCAR. “We are committed to working closely with pharmaceutical companies and the REMAP network to identify new and effective treatments for COVID-19 patients by serving as the U.S. sponsor for this important platform trial.”