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

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Eisai and Cogstate Expand Agreement for Global Development and Commercialization of Digital Cognitive Assessment Technologies

MELBOURNE, Australia, Oct. 25, 2020 /PRNewswire/ — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Cogstate, Ltd. (Headquarters: Melbourne, Australia and New Haven, USA, CEO: Brad O’Connor, “Cogstate”) announced today that the companies have entered into a collaboration whereby Eisai has secured the global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate, including the “Cogstate Brief BatteryTM” (CBB) for use in healthcare and other markets. This global licensing deal is an expansion of an existing partnership executed in August 2019 whereby Eisai secured exclusive development and commercialization rights in Japan for all cognitive function tests developed by Cogstate, including the CBB. Both companies plan to proceed with development globally of CBB as a tool for individuals to self-assess brain performance to support healthy lifestyle choices and preventative measures in daily life, as well as a medical device to aid healthcare professionals in clinical diagnosis decisions.    

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Developed by Cogstate, the CBB is a scientifically validated digital tool that enables cognitive function self-checks and consists of four tests evaluating psychomotor function, attention, learning and memory, and working memory. In the United States, Europe, Australia, New Zealand and Canada, the CBB has been adapted as a medical device named “CognigramTM” that has achieved marketing authorization by regulators in these jurisdictions and provides informative results for healthcare professionals to support clinical examination to aid in the diagnosis of MCI and dementia.

In its medium-term business plan, EWAY2025, Eisai is aiming to become a “Medico Societal Innovator” (a company that changes society through creating medicines and providing solutions). Eisai is creating next-generation medical remedies focused on the neurology and oncology areas as well as building disease ecosystem platforms, in order to provide environments and solutions including digital solutions for early diagnosis and early treatment.

Cogstate aims to make assessment of brain health as simple, common and informative as assessment of blood pressure. Cogstate’s technology, which is easy to use and available in over 70 languages, is supported by extensive scientific validation, including more than 600 peer reviewed publications. Cogstate technology has been used extensively in clinical trials, including trials conducted by Eisai.

The global agreement between Eisai and Cogstate will allow the two companies to replicate many of the advancements that have already been launched in Japan, where Eisai has developed and launched a new digital tool using the CBB, named “NouKNOWTM” (pronounced “NOH-NOH”), a non-medical device for self-assessment of brain performance (brain health). Eisai is currently investigating the possibility of developing a medical device using the CBB in Japan.

In recent years, various research has demonstrated the possibility that decline in brain performance may be mitigated through major readjustments to lifestyle, such as regular exercise and sleep, a well-balanced diet, and social interaction. However, according to a survey by Eisai, the number of people taking correct preventive actions or habitually performing self-checks of cognitive function

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