Global Coalition for Adaptive Research, Amgen, and Eisai Announce First Patient Enrolled in International COVID-19 Trial
Amgen and Eisai to Participate in the Immune Modulation Domain of REMAP-COVID, an Adaptive Clinical Trial to Test Interventions for Patients Hospitalized With COVID-19
Amgen’s Apremilast and Eisai’s Eritoran to Be Evaluated Across Multiple International Trial Sites Within the REMAP Network
Global Coalition for Adaptive Research (LOS ANGELES, CA), Amgen (THOUSAND OAKS, CA), and Eisai Co., Ltd. (TOKYO, Japan “Eisai”) — The Global Coalition for Adaptive Research (GCAR) in collaboration with Amgen and Eisai Co., Ltd., today announced enrollment of the first patient in the immune modulation domain of REMAP-COVID, a sub-study of REMAP-CAP (A Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia) that tests multiple interventions for the treatment of patients hospitalized with COVID-19. Amgen’s apremilast and Eisai’s investigational eritoran are being evaluated as potential therapeutic agents.
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REMAP-CAP was developed to test treatments for severe pneumonia both in non-pandemic and pandemic settings. In February 2020, REMAP-CAP rapidly pivoted to its pandemic mode (the REMAP-COVID sub-study), as per its original intent, to incorporate additional potential treatment regimens specifically targeting COVID-19 and to expand enrollment to COVID-19 patients. This trial is a multicenter, randomized platform study, with treatments tested within groupings or “domains” based on pathway or mechanism of action.
The trial is being conducted in the multi-hospital UPMC (University of Pittsburgh Medical Center) health system along with over 20 hospitals in the United States. Additional global sites across the trial network will follow. University of Pittsburgh is serving as the U.S. Regional Coordinating Center.
“Partnering with the biopharmaceutical industry to be able to efficiently test well-understood targeted agents is critical to understanding treatment paradigms for COVID-19 patients,” says Derek Angus, MD, MPH, FRCP, U.S. Principal Investigator of REMAP and Chief Healthcare Innovation Officer, UPMC Health System. “Today’s announcement marks an important milestone in the collaboration between industry and the scientific and academic community to work collectively to evaluate potentially promising therapies to support patients hospitalized with COVID-19.”
Amgen’s apremilast is an oral drug which inhibits the activity of PDE4 (Phosphodiesterase 4), an enzyme found in inflammatory cells in the human body. By inhibiting PDE4, apremilast is thought to modulate the production of inflammatory cytokines and other mediators, which may prove helpful in inhibiting the inflammatory response associated with the signs, symptoms and pulmonary involvements observed in some COVID-19 patients. Apremilast is currently approved for use in more than 45 countries as an oral treatment for inflammatory diseases including moderate to severe plaque psoriasis, psoriatic arthritis and oral ulcers associated with Behcet’s disease.
“Amgen believes that, based on its mechanism of action, apremilast might help prevent the respiratory distress seen in moderate to severe-stage adult COVID-19 patients,” said David M. Reese, M.D., Executive Vice President of Research and Development at Amgen. “We are proud to be joining REMAP-COVID, which is an important and innovative effort utilizing a platform approach and has the potential to rapidly identify whether apremilast
“I think that we have done quite well — I think the demographics of the Moderna trial have markedly changed,” Larry Corey, a virologist at Fred Hutchinson Cancer Research Center said in an interview last week. Corey is heading up the clinical trials under Operation Warp Speed, the federal effort to speed vaccine development.
“We hope that we continue to improve upon that, this is the first trial,” Corey said. ‘There are two others in the field, and two more scheduled to go — so our journey in covid-19 vaccines is just starting.”
Pharmaceutical giant Pfizer’s coronavirus vaccine trial is also nearing completion. Pfizer’s trial, which is not part of Operation Warp Speed, has enrolled 39,862 of its planned 44,000 participants. Of those, 34,601 have received their second, booster dose.
Half the participants in both trials receive the study vaccine and half receive a placebo, and more than 25,000 of Moderna’s participants have already received their second dose.
More than half of the volunteers in Moderna’s trial are healthy and not at high risk of severe covid-19, the disease caused by coronavirus. But 25 percent are at elevated risk due to age and 17 percent are younger, but have conditions such as diabetes or obesity that put them in a high risk group.
Moderna has projected having early data in the next month that may show whether its vaccine is effective. The company will determine whether that data is sufficient to apply for regulatory authorization once it has accumulated two months of safety follow-up on half the study participants, a milestone anticipated slightly before Thanksgiving.