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Press release content from Business Wire. The AP news staff was not involved in its creation.

Global Coalition for Adaptive Research Announces the Discontinued Evaluation of Apremilast in REMAP-COVID

July 12, 2021 GMT

LOS ANGELES--(BUSINESS WIRE)--Jul 12, 2021--

Global Coalition for Adaptive Research, the U.S. Sponsor of REMAP-COVID, announced that Amgen’s apremilast (Otezla) has ended evaluation in the REMAP-COVID study. Apremilast, an oral drug which inhibits the activity of PDE4 (Phosphodiesterase 4), was selected for evaluation because it was hypothesized to inhibit the inflammatory response associated with the signs, symptoms and pulmonary involvements observed in some COVID-19 patients by modulating the production of inflammatory cytokines.

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REMAP-CAP (A Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia) 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 (known as the REMAP-COVID sub-study in the U.S.), as per its original intent, to incorporate additional potential treatment regimens specifically targeting COVID-19 and to expand enrollment to COVID-19 patients. The international trial uses an innovative trial design to efficiently evaluate multiple interventions simultaneously with treatments tested within groupings or “domains” based on pathway or mechanism of action. Apremilast was evaluated within one of two domains of the study evaluating immune modulation. Other agents continue to be evaluated in this immune modulation domain of REMAP-COVID.

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To date, REMAP-CAP includes 48 current or completed interventions in 14 domains. Research from REMAP-CAP has supported numerous treatment guidelines for patients hospitalized with COVID-19 and results published or in press in over 14 publications including NEJM and JAMA.

About Global Coalition for Adaptive Research (GCAR)

The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) nonprofit organization uniting physicians, clinical researchers, advocacy and philanthropic organizations, biopharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases by serving as Sponsor of innovative and complex trials including master protocols and platform trials. GCAR is the U.S. Trial Sponsor of REMAP-CAP.

To learn more about GCAR, visit www.gcaresearch.org

About REMAP-CAP

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REMAP-CAP is led by world experts in critical care, clinical trials, pandemic and infectious disease outbreaks, virology, immunology, emergency medicine, and Bayesian statistics. REMAP-CAP has enrolled over 7,800 patients at 323 sites across 22 countries. This vital research is being conducted in collaboration with Berry Consultants, leaders in statistical design for adaptive platform trials, and is being supported by governments and non-profits worldwide.

To learn more about REMAP-CAP and the REMAP-COVID sub-study, please visit www.remapcap.org and follow @remap_cap.

View source version on businesswire.com:https://www.businesswire.com/news/home/20210712005211/en/

CONTACT: Rachel Rosenstein-Sisson

Rrosenstein.sisson@gcaresearch.org

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: HEALTH INFECTIOUS DISEASES CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY

SOURCE: Global Coalition for Adaptive Research

Copyright Business Wire 2021.

PUB: 07/12/2021 12:00 PM/DISC: 07/12/2021 12:01 PM

http://www.businesswire.com/news/home/20210712005211/en