The Indianapolis-based pharmaceutical giant hopes to enroll up to 400 people in a study to see if its drug baricitinib can treat patients with severe cases of Covid-19.
On Monday morning, pharmaceutical company Lilly announced that it has enrolled its first patient in a Phase 3 clinical trial to evaluate its rheumatoid arthritis drug, baricitinib, as a treatment for severe cases of Covid-19. The trial is a randomized, double-blind placebo experiment of up to 400 adults hospitalized with Covid-19.
“We expect to have results a few months from now,” says Patrik Jonsson, president of Lilly Bio-Medicines. He adds that the company expects to enroll enough patients in a short period of time, based on the enrollment rate of a complementary study currently underway being run by the National Institute of Allergy and Infectious Diseases (NIAID), which is looking at the combined use of baricitinib and Gilead’s drug remdesivir in severe Covid-19 cases.
Sold under the brand name Olumiant, baricitinib is a Janus Kinase (JAK) inhibitor already approved for use as a rheumatoid arthritis treatment in 70 countries, including the United States. This type of arthritis is an autoimmune disorder, meaning that the body’s immune system is mistakenly attacking itself – in this case, the lining surrounding the joints. JAK inhibitors like baricitinib help treat this condition by blocking the signals the body sends to the immune system, reducing the inflammation in the joints.
The hope is that this drug can do something similar for Covid-19. Severe cases of this disease can sometimes bring on what’s called a “cytokine storm” in the lungs, where the immune system attacks the virus so furiously that it ends up inadvertently destroying lug tissue as well. Preclinical work with this drug suggests that it may work in the same way – blocking certain immune signals to prevent that cytokine storm. Interestingly enough, Jonsson says, is that the drug may also prevent viral replication, though this activity hasn’t yet been confirmed.
The key metric in this clinical study is whether fewer people receiving baricitinib die or are placed on ventilators compared to patients receiving a placebo. The study will also look at other metrics, such as time to recovery, length of hospital stay, and others.
The Indianapolis-based pharmaceutical giant’s interest in using baricitinib as a potential treatment has its origin in a project from AI startup BenevolentAI, which aims to use artificial intelligence as a way to speed up drug discovery. In early 2020, the company began a project to investigate what existing, approved drugs might conceivably work as a treatment against Covid-19.
In early February, BenevolentAI published a study in The Lancet suggesting baricitinib as a potential Covid-19 treatment and followed up on its initial study with more data a few weeks later. These studies led Lilly to begin its own investigation of the drug’s potential use against Covid-19.
As it proceeds with this study, Jonsson says that if baricitinib is confirmed as being an effective treatment against Covid-19, the company would be ready to manufacturing at a scale to both meet the needs of Covid-19 patients as well as its existing patients for the drug, and doesn’t anticipate any shortages.
In addition to potentially repurposing its existing drug, Lilly is also working to develop two different antibody treatments for Covid-19. One, a monoclonal antibody discovered by Vancouver-based biotech company AbCellera, began a phase one clinical trial on June 1. The other, which it is co-developing with Shanghai-based Junshi Biosciences, began testing in China earlier this month, with a phase 1 trial to begin in the U.S. in June as well.
“We’re working at a speed we never have before,” says Jonsson. “We’re extremely committed and doing everything we can. We’re hoping for good data in the very near future.”