Incyte to Evaluate Lead Drug Jakafi for COVID-19 Infection

Incyte INCY announced that it is working with the FDA to initiate a phase III study, RUXCOVID, to evaluate the efficacy and safety of Jakafi plus standard-of-care (SoC) compared to SoC therapy alone in patients with COVID-19-associated cytokine storm.

The Jakafi study will be sponsored by Incyte in the United States and Novartis outside of the country. Moreover, Incyte plans to initiate a separate open-label emergency Expanded Access Program (EAP) in the United States. Under this protocol, eligible patients with severe COVID-19 associated cytokine storm are allowed to receive Jakafi while it is being evaluated for this indication.

The RUXCOVID and EAP studies are awaiting potential FDA approvals.

Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, those with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

Incyte’s shares have lost 11.7% in the year so far compared with the industry’s decline of 11.3%.


Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, some approved drugs are being tested to see if they are effective in treating infected patients.

The pandemic has put the spotlight on the biotech sector, which is striving hard to come out with effective treatments for the contagion at the earliest. While some are repurposing drugs, others are working on curative treatments for this infectious virus.  Repurposing drugs are being considered the shortest path to a plausible treatment.

Meanwhile, efforts to develop a vaccine to combat this deadly virus have accelerated in the last couple of weeks.  While the successful development of a vaccine will prevent infection and stop the virus from spreading further, there is a greater need for drugs/treatments for infected patients. Also, the development of a vaccine will require a longer timeframe.

Earlier, Regeneron REGN and partner Sanofi announced a program to evaluate their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19.

Gilead Sciences, Inc. GILD is currently working to evaluate the safety and efficacy of experimental Ebola treatment, remdesivir, as a potential treatment for COVID-19 in multiple ongoing studies. As the candidate has shown promising results in infected patients, investors are banking on Gilead for being the first company to come up with a treatment for this deadly disease. Initial data from the ongoing studies are expected in the upcoming weeks.

Apart from repurposing drugs, the biotech giants are working on other curative treatments. Regeneron has identified antibodies, which can possibly treat COVID-19. The company has also isolated antibodies from humans who have recovered from COVID-19 to maximize the pool of potent antibodies. The company plans to select the top two antibodies for a 'cocktail' treatment.

Biotech giant Amgen AMGN is the latest company to join the bandwagon. It recently collaborated with Adaptive Biotechnologies to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19.

Meanwhile, the FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products for use in certain hospitalized patients infected with COVID-19.

Desperate times call for desperate measures and pharma/biotech companies are running a race against time to successfully develop treatments and vaccines to combat this contagious disease.

Incyte currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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