Lilly Begins a Phase 3 Clinical Trial with Baricitinib for Hospitalized COVID-19 Patients

Study Will Further Understanding of Baricitinib’s Potential as a COVID-19 Treatment. Data Will Complement Ongoing NIAID Trial and Investigator-Initiated Trials.

June 18, 2020 08:00 ET | Source: Eli Lilly Canada

TORONTO, June 18, 2020 (GLOBE NEWSWIRE) -- Eli Lilly and Company announced that the first patient has been enrolled in a Phase 3 randomized, double-blind, placebo‑controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized adults with COVID-19. Baricitinib, marketed as OLUMIANT ® , is approved in 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).

Lilly expects to enroll 400 patients in the trial, with data expected in the next few months. The study will be conducted in the U.S., Europe and Latin America and includes patients hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry.

In COVID-19 infection, increased disease severity can be associated with a hyperinflammatory state. It is hypothesized that through JAK1 and JAK2 inhibition, baricitinib may reduce the cytokine storm associated with the complications of this infection. In addition, baricitinib may have a role in inhibiting the host cell proteins that assist in viral reproduction, reducing the ability of infected cells to make more virus. A manuscript detailing this mechanism of action of baricitinib in COVID-19 has been accepted for publication by EMBO Molecular Medicine .

The primary endpoint for Lilly’s study is the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 28 in patients treated with 4 mg of baricitinib daily (with background therapy) compared to placebo (with background therapy). Patients will receive baricitinib or placebo for up to 14 days or until discharge from the hospital. Key secondary outcomes of this study include the proportion of patients with clinical improvement at different time points, time to recovery, duration of hospitalization, number of ventilator-free days and mortality over a 28-day period.

“Lilly is committed to accelerating our efforts to find solutions for a pandemic that has impacted so many lives worldwide,” says Dr. Doron Sagman, Vice President, R&D and Medical Affairs, Eli Lilly Canada. “This rigorous clinical trial seeks to provide clarity on baricitinib’s potential efficacy in COVID-19 affected individuals, and hopefully brings us a step closer to a potential treatment option.”

The data from Lilly’s trial will complement data from the study of baricitinib with remdesivir in the second phase of the Adaptive COVID-19 Treatment Trial (ACTT-2) run by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This study – which enrolled its first patient last month – assesses the efficacy and safety of the combination of a 4 mg daily dose of baricitinib plus remdesivir, compared to remdesivir.

Lilly is also supporting select ongoing multisite and single-site investigator-initiated trials in Europe and North America for hospitalized patients with COVID-19 infections, including a trial in Nova Scotia, Canada. The trial is an independent 4-arm Phase 2 study, measuring investigational medications, including baricitinib, as adjuncts to clinical standard of care treatment to evaluate the safety and effectiveness of anti-COVID-19 treatment. These studies by academic and government institutions will provide information on hundreds of additional patients treated with baricitinib and either placebo or active comparators.

Should research efforts for baricitinib in COVID-19 prove successful, Lilly will continue to create adequate supply to support both appropriate clinical and investigational use.

Studying baricitinib in controlled trials is important in order to better characterize its potential benefits and understand the safety of its use as a COVID-19 treatment. The Canadian product monograph for the approved use of baricitinib for RA includes boxed warnings about the risk of developing blood clots and serious infections.

About Lilly’s COVID-19 Efforts Lilly is bringing the full force of its scientific and medical expertise to attack COVID-19 around the world. We are fighting the pandemic with everything we can: discovering potential medicines to treat and prevent COVID-19, maintaining a reliable supply of our medicines, and supporting patients and communities in times of need. Lilly is studying multiple approaches to treat COVID-19, including potential antibodies designed specifically to attack the virus and existing Lilly medicines to understand their potential in treating complications of COVID-19.

About OLUMIANT ® OLUMIANT (baricitinib), in combination with methotrexate (MTX), is indicated in Canada for reducing the signs and symptoms of moderate- to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs). OLUMIANT can be used as a monotherapy in cases of intolerance to MTX. 1

OLUMIANT is believed to interfere with the activity of an enzyme called Janus Kinase (JAK). Normally JAK enzymes help turn on your immune system when you need it. The immune system then causes swelling and tenderness. This is called inflammation. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases. 2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

About Lilly Canada Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people’s needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world’s first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca .

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Media Contact: Samira Rehman Rehman_Samira@lilly.com 647-617-1994

REFERENCES 1 OLUMIANT Product Monograph 2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.