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Three members of the COVID R&D Alliance – Amgen Inc., Takeda Pharmaceutical Co. Ltd. and UCB announced the first patient enrolled in the COMMUNITY Trial (COVID-19 Multiple Agents and Modulators Unified Industry Members). COMMUNITY is a randomized, double-blind, placebo-controlled, adaptive platform trial that enables an array of therapeutic candidates to be studied in hospitalized COVID-19 patients.
With worldwide COVID-19 deaths exceeding one million and a resurgence of cases globally, life science companies are working urgently to identify treatments that can potentially reduce clinical severity of COVID-19 in hospitalized patients. COMMUNITY is the first platform trial designed and launched by members of the COVID R&D Alliance, a group of more than 20 leading pharmaceutical and biotech companies who are devoting significant time, insights and company resources to speed the development of potential therapies, novel antibodies, and anti-viral therapies for COVID-19 and its related symptoms.
“As this insidious virus rapidly spreads around the globe, doctors need options to treat hospitalized patients who are actively sick and experiencing a range of symptoms as the disease progresses,” said David M. Reese, M.D., Executive Vice President Research & Development, Amgen. “Working hand-in-hand with our peers, we hope to find options that could potentially save lives of the patients who will need treatments for COVID-19 before widespread availability of a vaccine.”
COMMUNITY uses an adaptive design which allows for the addition, removal and simultaneous study of multiple therapeutic candidates during the course of the trial. Multiple candidates will be tested against a shared placebo-controlled arm. The design allows for a streamlined approach which may accelerate execution of the study and save time as we search for therapeutics in the fight against the pandemic. Immunomodulating therapies will be the first candidates to enter COMMUNITY. Other therapies may join in the future, such as antivirals.
The trial’s design and global footprint were selected to address potential barriers in the study of COVID-19 therapeutics. This includes anticipating and activating trial sites to align with the rise and fall of COVID cases across geographic regions as well as streamlining an influx in trial-related inquiries faced by some hospitals and health systems. COMMUNITY will onboard global sites in the United States, Brazil, Mexico, Russia, South Africa and other countries. This geographic diversity will allow the trial sites to be active when cases spike locally. COMMUNITY aims to simplify the study of investigational therapies that may result in potential treatment options and address the needs of hospitals in treating patients.
“COVID is not confined to one country, making it imperative that we share the challenges, successes and insights in real-time,” said Dhavalkumar Patel, Executive Vice President and Chief Scientific Officer, UCB. “By sharing our expertise and resources, we hope to arm care teams with promising investigational therapies to help patients who cannot wait.”
Uncontrolled vascular and immune inflammatory responses have proven to be hallmark symptoms in patients facing severe COVID-19 infections. These patients may face increased risk of acute respiratory distress syndrome (ARDS), stroke and death. Initial therapies entering into COMMUNITY were selected based upon their potential to suppress or control the immune response or the resulting inflammation. None of these therapies have been approved by the FDA, EMA, or other health authorities for the treatment of COVID-19 or its symptoms and are still investigational. These include:
COMMUNITY is studying hospitalized COVID-19 patients. This includes confirmed COVID-19 patients who may require either ongoing medical care, supplemental oxygen, noninvasive ventilation or high-flow oxygen devices, or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). By enrolling both hospitalized Intensive Care Unit and non-Intensive Care Unit patients, the trial seeks to yield greater understanding of how therapeutic interventions may be used with hospitalized COVID-19 patients experiencing a range of symptoms.
About COMMUNITY
COMMUNITY is an adaptive, randomized, double-blind, placebo-controlled platform study designed to assess multiple candidates as a potential treatment for hospitalized patients with COVID-19, a disease caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV 2). The focus of the trial is to identify an effective treatment(s) for hospitalized COVID-19 patients, who are Grade 2 to Grade 5 on a Clinical Severity Status 8-Point Ordinal Scale.
The primary endpoint of COMMUNITY is time to confirmed clinical recovery without being re-hospitalized through Day 29 based on the clinical severity status scale, which is defined as achieving a score of 6, 7, or 8. Key secondary endpoints are oxygen-free recovery, improvement from baseline or fit for discharge from baseline, and all-cause mortality.
Patients will be randomized equally to either the candidate agent plus the standard of care or a placebo plus standard of care in a double-blind fashion. Patients who are randomized to placebo plus standard of care will be subsequently randomized equally to a matching placebo corresponding to an available agent.
About the COVID R&D Alliance
Organized in March 2020, the COVID R&D Alliance is operating unconstrained by past models of development and is accelerating the study candidates without regard to company affiliation. Members are sharing clinical trial data and real-world evidence, as well as crowd-sourcing early stage candidates to identify mechanisms and treatments that may be effective against COVID-19. Initial efforts by the group focus on advancing well understood therapies and late-stage investigational medicines for hospitalized patients who need treatment options. Activities are testing re-purposed molecules and early stage candidates. Member companies have 40 trials expected to have findings in the coming months.
About Zilucoplan
Zilucoplan, an investigational drug product, is a once-daily self-administered, subcutaneous peptide inhibitor of C5 which is in Phase III development for the treatment of generalized Myasthenia Gravis (gMG). Zilucoplan is also being investigated in immune-mediated necrotizing myopathy (IMNM), amyotrophic lateral sclerosis (ALS) and other tissue-based complement-mediated disorders. Zilucoplan has not been approved by any regulatory authority for any indication.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing better health and a brighter future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.
About UCB
UCB is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7,600 people in approximately 40 countries, the company generated revenue of €4.9 billion in 2019. UCB is listed on Euronext Brussels.
