As drug companies in the U.S. and around the world race to come up with treatments and therapies that could be used to combat Covid-19, Eli Lilly (LLY) – Get Report has joined in, testing treatments in study and its portfolio that appear to have promise for patients.
The drugmaker is currently looking at two products, baricitinib, a rheumatoid arthritis medication sold under the brand name of Olumiant, and LY3127804, a type of selective monoclonal antibody that’s currently in early clinical study for tumor treatment.
Other companies searching for possible treatments and vaccines include the U.S.’ Gilead Sciences (GILD) – Get Report, Regeneron (REGN) – Get Report, Moderna (MRNA) – Get Report, Emergent BioSolutions (EBS) – Get Report and Japan’s Takeda (TAK) – Get Report and Fujifilm (FUJIY) — several of these medications were looked at in a comprehensive report in the Journal of the American Medical Association that also mentioned baricitinib. But so far no therapy or cure has been proven effective for the disease caused by the novel coronavirus, and a vaccine is at least a year away, at best.
Baricitinib is known as a type of janus kinase inhibitor, or JAK1/JAK2 inhibitor, used for the autoimmune disease rheumatoid arthritis. It has already been approved in the U.S. and dozens of other countries for adults with moderate to severe rheumatoid arthritis.
Picking up on the anti-inflammatory properties of the drug, a British company called BenevolentAI used artificial intelligence to find that baricitinib might help in also treating Covid-19 patients.
Some research has suggested that a small but significant number of patients with severe Covid-19 may suffer from what’s known vaguely as “cytokine storm syndrome” — a kind of raging hyper-inflammatory response that ends up harming the body and is believed to play a role in a number of deaths from the virus.
Now, baricitinib will be studied by the National Institute of Allergy and Infectious Diseases in an adaptive Covid-19 treatment trial. Results are expected in a few months.
TheStreet asked Patrik Jonsson, senior vice president of Eli Lilly and of Lilly Bio-Medicines about the treatments over email last week. The interview has been edited for clarity and length.
TheStreet: Could you explain the role inflammation seems to play in the body’s response to the disease and what that means for outcomes?
Jonsson: Baricitinib is a JAK1/JAK2 inhibitor. These molecules block how cells respond to some cytokines, which are proteins that allow cells to communicate with each other. Excess cytokines may cause inflammation: In rheumatoid arthritis, joint inflammation may cause pain, swelling, and tenderness.
Due to nonclinical evidence showing the drug’s ability to help disrupt how cells respond to cytokines, it is believed that baricitinib may be capable of reducing or interrupting the passage of Covid-19 into target cells and inhibiting the JAK1- and JAK2-mediated cytokine release associated with the virus.
Investigators are also exploring another hypothesis that baricitinib may be a potential Covid-19 treatment due to a possible antiviral effect. The hypothesis here is that the baricitinib would work as an inhibitor for the host-cell protein that may assist in viral reproduction. So, by inhibiting this host cell protein, baricitinib could mitigate viral propagation.
However, inflammation plays a dual role in protecting the body from infections and in the case of Covid-19, it contributes to the cytokine storm. So we need to conduct randomized clinical trials to fully understand the benefit and risk of baricitinib in Covid-19. U.S. prescribing information includes boxed warnings regarding the use of baricitinib, including warnings about risk for developing serious infections, a risk that may be related to baricitinib’s effects on the immune system.
TheStreet: What types of patients do you suspect would most benefit from this type of anti-inflammatory therapy?
Jonsson: The National Institute of Allergy and Infectious Diseases will be investigating the efficacy and safety of baricitinib as a potential treatment for hospitalized patients diagnosed with Covid-19 in a population with moderate to severe disease. Overall, it’s believed that baricitinib could provide the greatest benefit to hospitalized patients.
TheStreet: It sounds like this is widely used already, so if it’s viewed as effective, how quickly do you think it could be used to treat patients?
Jonsson: The baricitinib arm of NIAID’s Adaptive Covid-19 Treatment Trial will begin this month in the U.S. with a planned expansion to additional sites including Europe and Asia. It will investigate the efficacy and safety of baricitinib as a potential treatment for hospitalized patients. Results are expected within the next few months.
We are also supporting select planned and ongoing multi-site and single-site investigator-initiated trials in Europe and North America for hospitalized patients with Covid-19 infections. In addition, we are aware that baricitinib is being tested by independent investigators. While we weren’t approached for these particular trials, we look forward to understanding the data and patient outcomes from these independent studies.
TheStreet: As for LY3127804, it was studied for tumor therapy, correct? Could you explain what role it would play as a therapy for Covid-19 patients with pneumonia?
Jonsson: LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2, is currently in a Phase 1 study in combination with (cancer drug) ramucirumab in people with advanced solid tumors.
Angiopoietin 2 is known to be elevated in acute respiratory distress syndrome patients and Lilly will test whether inhibiting the effects of it with a monoclonal antibody can reduce the progression to acute respiratory distress or the need for mechanical ventilation in Covid-19 patients….
In the phase 2 clinical trial, LY3127804 will be tested in pneumonia patients hospitalized with Covid-19 who are at a higher risk of progressing to acute respiratory distress syndrome. This study will be a randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants who are hospitalized with pneumonia and presumed or confirmed Covid-19. The primary outcome measure is the number of ventilator-free days. The trial will begin later this month at several U.S. centers.