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Lilly Starts Phase 3 Clinical Trial With Baricitinib For Hospitalized COVID-19 Patients

Eli Lilly and Co. (LLY) said Monday that it has enrolled the first patient 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 or RA.

Lilly expects to enroll 400 patients in the trial, with data expected in the next few months. It will conduct the study 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 company noted that the primary endpoint for its 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 the 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 also supports select ongoing multisite and single-site investigator-initiated trials in Europe and North America for hospitalized patients with COVID-19 infections.

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