Is baricitinib (Olumiant) being used to treat COVID-19?
Medically reviewed by Drugs.com. Last updated on April 17, 2020.
Eli Lilly has announced that a phase II/III trial of baricitinib (Olumiant) is set to begin in the US in April 2020. The trial will evaluate the safety and efficacy of baricitinib in patients with COVID-19 who have developed pneumonia and require supportive care.
The trial will initially be conducted in Denver, Colorado, but it’s expected that clinical trials of baricitinib will expand to include sites in Europe and Asia as well. The phase II single-arm, open-label part of the trial will enrol 20 patients who will receive oral baricitinib 2 mg once daily for 14 days. The phase III part of the trial will enrol a further 60 patients, who will be followed up for 29 days.
What to know about baricitinib
Baricitinib is a janus kinase (JAK) inhibitor, which inhibits both the JAK1 and JAK2 subtypes. Janus kinase, and other protein kinases, are enzymes that regulate the biological activity of proteins in our body.
Baricitinib comes in the form of an oral tablet that is already approved by the US Food and Drug Administration (FDA) for the treatment of certain patients with rheumatoid arthritis. Long-term use of the drug is known to be associated with an increased risk of serious infection, lymphoma and other cancers, as well as blood clots. COVID-19 patients, however, won’t be on the treatment long term and will just receive a short, 2-week course of the drug.
Why is baricitinib being investigated for COVID-19?
Baricitinib has anti-inflammatory properties and it is hoped that it could help against the inflammatory cytokine storm seen in severe cases of COVID-19.
Research into baricitinib has also shown that it is also capable of inhibiting NAKs (numb-associated kinases). NAKs are thought to regulate the process by which SARS-CoV-2, the virus that causes COVID-19, infects cells. This process is called clathrin-mediated endocytosis. Baricitinib is expected to be more effective than other similar drugs because it has a particular high affinity for AAK1 (adaptor-associated kinase 1), which is a part of the NAK family of kinases.
How was baricitinib identified as a possible treatment for COVID-19?
In February 2020, the UK-based company BenevolentAI, made use of its artificial intelligence (AI) platform to identify baricitinib as a potential treatment for COVID-19. The company integrates AI technologies into the drug discovery process. Benevolent used its technology to try and identify an existing drug that could stop COVID-19 progressing, inhibit the cytokine storm seen in severe cases and also reduce damage caused by the inflammation associated with the disease.
When will we hear more?
On April 10, 2020, Eli Lilly reported that results from the first clinical trial of baricitinib for the treatment of COVID-19 are expected within the next 2 months.
- Clinicaltrial.govt. Safety and Efficacy of Baricitinib for COVID-19. [Accessed April 17, 2020]. Available online at: https://clinicaltrials.gov/ct2/show/NCT04340232?term=baricitinib&draw=2&rank=2.
- Lilly. Lilly Begins Clinical Testing of Therapies for COVID-19. April 10, 2020. [Accessed April 17, 2020]. Available online at: https://investor.lilly.com/news-releases/news-release-details/lilly-begins-clinical-testing-therapies-covid-19.
- Dailymed. OLUMIANT- baricitinib tablet, film coated. November 13, 2019. [Accessed April 17, 2020]. Available online at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=866e9f35-9035-4581-a4b1-75a621ab55cf.
- Stebbing J, Phelan A, Griffin I, et al. COVID-19: combining antiviral and anti-inflammatory treatments. Lancet. 20(4), p400-402, April 01, 2020. DOI: https://doi.org/10.1016/S1473-3099(20)30132-8.
- Tech Crunch. Potential new treatment for COVID-19 uncovered by BenevolentAI enters trials. April 15, 2020. [Accessed April 17, 2020]. Available online at: https://techcrunch.com/2020/04/14/potential-new-treatment-for-covid-19-uncovered-by-benevolentai-enters-trials/.
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