L-R: NIAID Vaccine Research Center Director John Mascola, NIAID Director Anthony Fauci and President Donald Trump, at a March 3 briefing about research on Covid-19
A large drug company is enlisting one of its approved products in the fight against Covid-19.
Indianapolis-based Eli Lilly said Friday that it had reached an agreement with the National Institute of Allergy and Infectious Diseases to study the drug Olumiant (baricitinib) in hospitalized patients with the disease caused by the SARS-CoV-2 virus in a clinical trial of multiple therapies.
Starting this month, the drug will form an arm of the NIAID’s Phase III Adaptive Covid-19 Treatment Trial, or ACTT, which is designed to investigate various experimental treatments for the disease. The ClinicalTrials.gov page for the study states it will include about 75 sites around the world and has an enrollment target of 440 patients. Lilly said results for Olumiant would be available within two months. The ACTT page currently lists an arm testing Gilead Sciences’ remdesivir against placebo. Early compassionate use data for that drug were announced Friday, and some early clinical trial data are expected this month.
Separately, Lilly also started a Phase II study of an investigational anti-angiopoietin 2 monoclonal antibody, LY3127804, in pneumonia among Covid-19 patients who are at high risk of progressing to acute respiratory disease syndrome, or ARDS. The page for the study was posted Monday and as of the morning was still listed as not yet recruiting patients, with an April 18 start date. It is expected to enroll 200 patients in a randomized, double-blind and placebo-controlled manner, reaching completion in July.
Olumiant is a JAK1/JAK2 inhibitor approved for treating rheumatoid arthritis. The hypothesis is that its anti-inflammatory properties may benefit patients with Covid-19 due to the inflammatory response the disease causes and that has been cited as a major culprit in severe illness and death. Several other anti-inflammatory drugs are also being tested in the disease, including fellow JAK inhibitors like Incyte and Novartis’ Jakafi (ruxolitinib) and Pfizer’s Xeljanz (tofacitinib), along with Regeneron Pharmaceuticals and Sanofi’s Kevzara (sarilumab) and Roche’s Actemra (tocilizumab).
“There is an urgent need for new strategies to help hospitalized Covid-19 patients, many of whom will progress to respiratory failure,” said Dr. Vincent Marconi, a professor of medicine at ACTT trial site Emory University, in a statement for Lilly. “This NIAID study presents an important opportunity to test whether [Olumiant] can help these patients.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In addition to Olumiant’s inclusion in the ACTT study, ClinicalTrials.gov also lists three investigator-sponsored studies of the drug, including a Phase II/III trial at the University of Colorado in Denver, a Phase II study in Nova Scotia and a Phase III trial in Italy.
Photo: Brendan Smialowski, AFP, via Getty Images
