New Crown Outbreak: 8.12 million worldwide! Lilly Launches COVID-19 Phase III Trial: JAK1/2 Inhibitor Olumiant Treats Cytokine Storm!

, June 16, 2020 /
BIOON/ -- At present, the outbreak of new crown pneumonia abroad is still spreading rapidlyAccording to Baidu's "Real-timeBig DataReport on The New Coronavirus Pneumonia Outbreak", as of 18:00 on June 16, 2020, more than 813.7 million cases had been confirmed worldwide, and 8052,000 cases and 434,000 deaths had been confirmed abroadthe unprecedented situation of the new crown epidemic, governments are urgently authorizing the potential for the treatment of severe neo-coronary pneumonia, including antiretroviral drugs, antimalarial drugs, anti-inflammatory drugs, plasma during rehabilitation, etcAt present, a number of pharmaceutical companies have been involved in the new coronavirus pneumonia (COVID-19) drug / vaccine research and development ranks,Lillyannounced that a randomized, double-blind, placebo-controlled phase III trial for the treatment of adult patients with neo-coronal pneumonia (COVID-19) using oral JAK1/JAK2 inhibitor baricitinib for treatment has been enrolled in the first case of patientsCurrently, baricitinib has been approved in 70 countries worldwide and sold under the brand name Olumiant for the treatment of adult patients with moderate to severe activerheumatoid arthritis (RA) adultsLillyexpects the Phase III trial to be in a group of 400 patients, with data expected to be released in the coming monthsThe study, which will be conducted in the United States, Europe and Latin America, involved adults hospitalized for a new coronavirus (SARS-CoV-2) infection, an elevated inflammatory marker, and adults who did not need invasive mechanical ventilation at the start of the studyIn the study, patients were randomly assigned, treated with baricitinib or a placebo for 14 days or until they were discharged from the hospitalThe main endpoint of thestudy was the proportion of patients who received a daily dose of 4 mg baricitinib (combined background therapy) who died during the 28-day period or needed noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation compared to patients who received a placebo (combined background therapy) patientsKey secondary endpoints include the proportion of patients with clinical improvement at different points in time, recovery time, length of hospital stay, number of days without a ventilator, and mortality rates over 28 daysin COVID-19 infections, an increase in the severity of the disease may be related to inflammatory statesit is assumed thatby inhibiting JAK1 and JAK2, baricitinib could reduce cytokine stormassociated with complications of the infectioncytokine storm is a severe immune overreaction that can cause respiratory damage in patients with COVID-19 and lead to life-threatening respiratory complicationsIn addition, baricitinib may play a role in inhibiting host cell proteins that aid virus reproduction and reducing the ability of infected cells to produce more virusesA manuscript of an article accepted by the international medical journal EMBO Molecular Medicine details the mechanism secostiib's role in the treatment of COVID-19The Phase IIIclinical trialconducted by Lillywill supplement the data from the Second Phase II study of baricitinib and Redsewe's combination of drugs conducted by the National Institutes of Allergy and Infectious Diseases (NIAID) under the National Institutes of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH)The study, which was the first of its kind last month, will assess the efficacy and safety of 4mg baricitinib in conjunction with Redsiwe, single-use Redsiwe"
Lilly committed to fighting this global epidemic, including testing whether existing drugs, including baricitinib, can help treat COVID-19 complications in patients," said Patrik Johnson, senior vice president and president of Lilly Biopharmaceuticals at This randomized controlled study is an important step in our understanding of baricitinib as a potential COVID-19 treatment "After the successful treatment of moderate-to-moderate COVID-19 at Remdesivir, hospital patients still need new ways to reduce mortality," said Vincent C Marconi, M.D., professor of medicine and global health at embemouniversity School of Medicine and Emory Rawlings School of Public Health at the Several ongoing baricitinib studies will provide the necessary data for combination therapy between antiviral activity and the suppression of cytokine storms "
study baricitinib in a controlled trial is important for better describing its potential benefits and understanding its safety as a TREATMENT for COVID-19 Lilly is also supporting a number of multisite and single-site clinical trials in Europe and North America that have been initiated by researchers to treat patients with COVID-19
These studies, conducted by academic institutions and government agencies, will provide information on the treatment of hundreds of patients who received baricitinib, placebo, and positive control drugs If baricitinib's research efforts in COVID-19 treatment are proven to be successful, lilly will continue to produce sufficient supplies to support clinical and research use Olumiant's active pharmaceutical ingredient is baricitinib, a selective, reversible JAK1 and JAK2 inhibitor that is taken daily orally and is currently clinically developed for the treatment of a variety of inflammatory diseases and autoimmune diseases, including r rheumatoid arthritis (RA), psoriasis, diabetes kidney disease, dit-
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matoritis, and erythne There are 4 kinds of JAK enzymes, namely JAK1, JAK2, JAK3 and TYK2 JAK-dependent cytokines are involved in the onset of a wide range of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be widely used in the treatment of various inflammatory diseases In the kinase test, baricitinib showed 100 times more inhibition intensity against JAK1 and JAK2 than JAK3 Lilly and Incyte reached an exclusive cooperation agreement in 2009 to jointly develop Olumiant and some subsequent compounds To date, Olumiant has been approved by 70 countries worldwide, including the United States, the European Union and Japan, as a single drug or combination of methotrexate for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) who have one or more disease-modified anti-rheumatoid drugs (DMARDs) that alleviate inadequate or ilerating intolerance In clinical studies, Oluminant significantly improved RA symptoms and signs compared to standard nursing therapies such as methotrexate monodrug therapy, Adamum monoantithecombination background methotrexate therapy in addition to Lilly , in April, Novartis announced a phase III clinical trial (RUXCOVID) with Incyte to evaluate the jak1/2 inhibitor ruxoinib (Jakafi/Jakavi) joint standard care (SoC) treatment for COVID-19-related cytokine storms In the collaborative study, Incyte will sponsor u.S.-area, Novartis will sponsor trials outside the U.S ruxolitinib is an original oral JAK1/JAK2 inhibitor Overactivation signals through the JAK-STAT pathway are associated with a variety of cancer-related and other severe immunomediated diseases, such as transplant-resistant host disease (GVHD) Since many patients with severe respiratory diseases (such as pneumonia) caused by COVID-19 have characteristics consistent with cytokine storms and JAK-STAT pathway activation enhancement, it can be speculated that ruxolitinib may play a role in the treatment of these patients (BioValleyBioon.com) original source: Lilly Begins Phase a 3 Clinical Trial with Baricitinib for COVID-19 Patients