Eli Lilly Arthritis Drug Being Tested in COVID-19 Clinical Trial
The COVID-19 clinical trial will study the safety and efficacy of baricitnib as a potential therapy for hospitalized coronavirus patients.
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By - Eli Lilly and Company recently announced that it partnered with the National Institutes of Allergy and Infectious Diseases (NIAID) to study baricitinib as part of NIAID’s Adaptive COVID-19 treatment clinical trial.
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NIAID, part of the National Institutes of Health (NIH), will investigate the efficacy and safety of baricitinib as a potential treatment for hospitalized patients with COVID-19. The clinical trial will begin this month with planned expansions in Europe and Asia. Results are expected within the next two months.
“Lilly is moving at top speed and using all available resources to help fight this pandemic," Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories, said in the announcement. "Developing potential therapeutic medicines for COVID-19 is part of our vital and humanitarian mission. To be successful, we must combine resources, data and expertise, with government, academia and other companies. We look forward to seeing the results of baricitinib and anti-Ang2 clinical studies."
Baricitinib is an oral JAK1/JAK2 inhibitor marked as Olumiant and is approved in more than 65 countries as a treatment for adults with moderate to severe active rheumatoid arthritis.
The pharmaceutical company also warned about the risk of developing serious infections which may be related to baricitinib's effects on the immune system. Given the inflammatory cascade seen in COVID-19, baricitinib's anti-inflammatory activity may have potential beneficial effects against the virus and warrants further study in infected patients.
In addition to the agreement, Lilly also announced that it will advance LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase 2 testing in pneumonia patients hospitalized with COVID-19. The antibody will be tested in COVID-19 patients who are at higher risk of progressing to acute respiratory distress syndrome (ARDS).
"There is an urgent need for new strategies to help hospitalized COVID-19 patients, many of whom will progress to respiratory failure," said Vincent C. Marconi, MD, professor of medicine and global health at Emory University School of Medicine, one of the U.S. sites for NIAID's ongoing COVID-19 Treatment Trial. "This NIAID study presents an important opportunity to test whether baricitinib can help these patients."
Supply chain shortages is an increasing concern as the COVID-19 pandemic increases. Lilly does not currently anticipate any shortages for any of its medicines, including baricitnib, which is available in countries where it is approved.
Eli Lilly isn’t the only company repurposing rheumatoid arthritis drugs as potential COVID-19 treatments.
In mid-March, Roche announced that it initiated a randomized Phase III clinical trial to uncover the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard care in hospitalized adult patients with COVID-19 pneumonia.
Actemra/RoActemra was the first approved biologic available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis.
Roche worked with FDA and BARDA to launch the first global study of Actemra/RoActemra in this setting. Nearly 300 patients are expected to be enrolled sometime this month.
The clinical trial goal is to find clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables.
The drug is not currently approved by FDA, but Actemra/RoActemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on March 3, 2020.
“We are initiating a clinical trial to study Actemra/RoActemra for the treatment of people hospitalized with COVID-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development.
“In these unprecedented times, today’s announcement is an important example of how industry and regulators can collaborate quickly to address the COVID-19 pandemic, and we will share the results as soon as possible.”
