World's Leading Life Science Companies Now Enrolling COMMUNITY, A Global, Platform Trial For Hospitalized Patients With COVID-19
THOUSAND OAKS, Calif., Nov. 30, 2020 /PRNewswire/ -- Three members of the COVID R&D Alliance - Amgen Inc. (NASDAQ: AMGN), Takeda Pharmaceutical Co. Ltd. (NYSE: TAK), and UCB (Euronext BR: UCB) - today 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:
-Amgen's OTEZLA® (apremilast), which may suppress immune response inflammation;
-Takeda's investigational intravenous administration of lanadelumab, which modulates the kallikrein-kinin system and suppresses production of bradykinin, potentially lessening inflammation;
-UCB's zilucoplan, an investigational medicine that may reduce overactivation of the immune system that contributes to ARDS.
https://www.amgen.com/
