New Crown Outbreak: 29.25 million! Lilly/Incyte Oral JAK Inhibitor Olumiant and Redsiway Phase 3 Clinical: Significantly Shorter Recovery Time!

September 15, 2020 / / -- At present, the outbreak of new crown pneumonia abroad is still spreading rapidly.
according to Baidu's Real-Time Big Data Report on the Outbreak of New Coronavirus Pneumonia, as of September 15, 2020, there were more than 29.25 million confirmed cases and more than 929,000 deaths worldwide.
, an antiviral drug based on Gilead Sciences, is a highly-focused COVID-19 potential drug.
may, the drug was granted emergency use authorization (EUA) by the FDA for the treatment of hospitalized patients with severe COVID-19.
addition, since May this year, Redsyve (veklury®) has been approved in many countries and regions around the world, including the European Union and Japan, for the treatment of COVID-19 patients.
, Gilead filed Veklury's new drug application (NDA) with the FDA.
the end of August, the FDA again awarded Veklury EUA for the treatment of moderate COVID-19 patients.
EUA expanded Veklury's previous authorization to treat all COVID-19 inpatients, regardless of oxygen status.
recently, Eli Lilly and Incyte released preliminary data on the adaptive COVID-19 therapeutic trial (ACTT-2) sponsored by the National Institutes of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
ACTT-2, which includes more than 1000 patients, began evaluating the efficacy and safety of the 4mg dose of oral JAK inhibitor baricitinib in hospital on May 8.
data show that the study reached its main end point: baricitinib combined with Redsywe to shorten the recovery time of patients compared to Redsiway.
researchers noted that the time to mid-level recovery was reduced by about a day compared to patients treated with redsiweiser.
results are statistically significant.
is defined as if the patient is in good health enough to be discharged from the hospital, which means that the patient no longer needs to be replenished with oxygen or medical care in the hospital, or is no longer hospitalized on the 29th day.
study also reached a key secondary endpoint: comparing patients' prognostics on the 15th day using a sequence of eight component scales, from full recovery to death.
that throughout the trial, an independent data and safety monitoring committee oversees the double-blind randomized controlled trial, which meets regularly to review security data.
other analyses are under way to understand other clinical outcome data, including mortality and safety data.
NIAID is expected to publish the full details of the study in a peer-reviewed journal.
, according to ACTT-2 data, Lilly plans to discuss the possibility of an emergency use authorization (EUA) with the U.S. FDA and explore similar measures with other regulators to treat COVID-19 inpatients.
if licensed, Lilly will recommend providing baricitinib through commercial channels and will work with hospitals and governments to ensure patients receive treatment.
will continue to create adequate supplies for rheumatoid arthritis (RA) patients and ensure that baricitinib remains available in approved countries.
the United States, baricitinib is approved for use in RA patients at a daily dose of 2 mg, and the EUA may approve a dose of 4 mg for the treatment of COVID-19.
Lilly will review ACTT-2 data with NIAID and assess any impact on COV-BARRIER, a randomized, double-blind, placebo-controlled Phase 3 study conducted in the United States, Europe, Asia and Latin America to assess the efficacy and safety of baricitinib combined background therapy for hospitalized COVID-19 adults.
Olumiant's active pharmaceutical ingredient is baricitinib, a daily oral selective, reversible JAK1 and JAK2 inhibitors that is currently under clinical development for the treatment of a variety of inflammatory and autoimmune diseases, including rheumatoid arthritis (RA), psoriasis, diabetic nephropathy, endexual dermatitis, systemic lupus erythematosus, etc.
there are four types of JAK enzymes, JAK1, JAK2, JAK3 and TYK2.
involve JAK-dependent cytokines in the onset of a variety of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be widely used to treat a variety of inflammatory diseases.
in kinase tests, baricitinib showed 100 times more inhibition for JAK1 and JAK2 than JAK3.
Lilly and Incyte reached an exclusive cooperation agreement in 2009 to jointly develop Olumiant and a number of subsequent compounds.
To date, Olumiant has been approved by 70 countries around the world, including the United States, the European Union, and Japan, as a single drug or combination methotrexate for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) who are insufficiently or insatiable for one or more disease modification anti-rheumatoid drugs (DMARD).
in clinical studies, Oluminant significantly improved RA symptoms and signs compared to standard care therapies such as methotrexate monotherapy, Adamo monotherapy, and Adamo monoantigen background methotrexate therapy.
() Original source: Baricitinib in Group with Remdesivir Reduces Time to Recovery in Hotel Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial.