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Lilly Begins Phase III Study on Olumiant for Coronavirus

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Eli Lilly & Company’s (LLY - Free Report) announced that the first patient has been dosed in a phase III study to evaluate its JAK inhibitor, Olumiant (baricitinib) as a potential treatment for hospitalized patients diagnosed with COVID-19. Olumiant is presently approved for the treatment of moderately to severely active rheumatoid arthritis (RA).

The study, to be conducted in the United States, Europe and Latin America, will enroll 400 patients who have at least one marker of inflammation but do not require mechanical ventilation. In the study, patients will be given either 4 mg dose of Olumiant daily (with background therapy) or placebo (with background therapy) for up to 14 days or until discharge from the hospital. The study’s primary endpoint will be to measure the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 28. Data from the study is expected to be released in a few months.

Olumiant is being studied for COVID-19 on the assumption that JAK1 and JAK2 inhibition may reduce the severe immune reaction known as cytokine storm, a complication associated with COVID-19.

The study will complement an already ongoing study of Olumiant with Gilead’s (GILD - Free Report) remdesivir being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) for hospitalized patients with COVID-19 infections. The NIAID study dosed the first patient last month.

Lilly’s shares have risen 7.7% this year so far against a decrease of 5% for the industry.

 

 

In a separate press release, Lilly announced that the FDA has granted approval to Lyumjev, its ultra-rapid-acting lispro, a new fast-acting formulation of Lilly’s insulin lispro (Humalog) to improve glycemic control in adults with type I and type II diabetes. The list price of Lyumjev will be the same as the list price of Humalog. Lyumjev was approved in the European Union in March this year.

Lilly is making rigorous efforts to make medicines/antibodies to treat COVID-19. Lilly already has two antibody candidates in phase I studies for treating COVID-19. Last week, its partner China-based Junshi Biosciences dosed the first healthy volunteer in a phase I study on JS016, their antibody candidate for treating COVID-19.

Lilly signed the deal with Junshi last month to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Lilly will soon begin its phase I study in the United States.

Earlier this month, Lilly also initiated a phase I study on LY-CoV555, its second lead antibody therapy candidate in collaboration with private biotech, AbCellera. Lilly signed the deal with AbCellera in March to create antibody therapies to treat and prevent COVID-19.

The phase I study on LY-CoV555 will evaluate its safety and tolerability in patients hospitalized with COVID-19. Results from the study are expected in June, following which it plans to initiate broader efficacy studies.

Several other companies are also working on developing new antibodies to combat the disease.

Vir Biotechnology’s (VIR - Free Report) investigational monoclonal antibodies, VIR-7831 and VIR-7832 are expected to directly go to phase II clinical studies sometime in 2020. Regeneron (REGN - Free Report) is developing REGN-COV2, a novel investigational antibody "cocktail" treatment designed to prevent and treat the SARS-CoV-2 virus. Clinical studies began this month.

Lilly currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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