Coronavirus Treatment Search Still on, Lilly, Gilead Give Updates

Kinjel Shah

There are concerns of a fresh wave of coronavirus cases emerging in the United States with protests breaking out across the country, triggered by the death of George Floyd, a black American at the hands of a police officer. The deadly coronavirus disease has already infected more than 6.0 million and killed more than 3,77,000 people globally.

The economic damage caused by the coronavirus-related lockdowns has made it all the more important for the pharma and biotech sector to find a treatment/vaccine for COVID-19 so that things can get back to normal. In this regard two large drugmakers came out with updates from their efforts to make medicines to treat the deadly disease.

Lilly Begins Human Study on Potential Coronavirus Antibody

Eli Lilly LLY has initiated the first clinical study on a potential antibody therapy, which has been specifically designed to attack SARS-CoV-2, the virus that causes COVID-19. The first patients have been dosed (in various centers in United States) in a phase I study on LY-CoV555, Lilly’s lead antibody therapy candidate in its collaboration with private biotech, AbCellera. Lilly signed the deal with AbCellera in March to create antibody therapies to treat and prevent COVID-19. LY-CoV555 is the first candidate to emerge from the collaboration and Lilly claims it has the potential for both prevention and treatment of COVID-19.

Lilly said it developed the antibody in just three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified virus-neutralizing antibodies isolated from the blood sample of a U.S. COVID-19 patient who recovered from the disease

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. Lilly is also beginning  large-scale manufacturing of this potential therapy simultaneously with its R&D efforts. Lilly plans to study LY-CoV555 in more vulnerable populations if results of the phase I study are positive.

Gilead’s Mixed Remdesivir Data on Moderate COVID-19 Patients

Gilead GILD announced mixed results from the second phase III study (SIMPLE) evaluating 5-day and 10-day courses of its investigational antiviral remdesivir plus standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia. The data showed that patients in the 5-day treatment arm were 65% more likely to have clinical improvement at Day 11 compared to SOC alone. However, statistical significance was not reached for the 10-day treatment course of remdesivir, though it produced favorable data.

In April, Gilead had announced data from the first phase III SIMPLE study evaluating remdesivir in hospitalized patients with severe manifestations of COVID-19. The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course. Overall, it looks like the 5-day course of remdesivir could prove to be effective for COVID-19 treatment.

Gilead and Roche are also testing remdesivir plus Roche’s Actemra/RoActemra in a phase III study, which began last week in hospitalized patients with severe COVID-19 pneumonia.

While Lilly has a Zacks Ran k #1 (Strong Buy), Gilead has a Zacks Rank of 2.You can see the complete list of today’s Zacks #1 Rank stocks here.

Antibodies/Treatments for COVID-19

Gilead and Lilly are just two of the many companies that are working on developing new antibodies and drugs to combat the disease

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

Other than Lilly, larger companies like Pfizer PFE, Biogen, Glaxo GSK and Amgen also have signed collaborations with smaller biotechs to co-develop antibody therapies/medicines to treat COVID-19.  Separately, many marketed drugs like Sanofi,/Regeneron’sIL-6 inhibitor Kevzara, Roche’s IL-6 inhibitor, Actemra, Incyte/Novarts’ JAK1/JAK2 inhibitor, Jakafi, AstraZeneca’s BTK inhibitor, Calquence, Amgen’s PDE4 inhibitor, Otezla  among others are being evaluated to treat respiratory complications associated with COVID-19, which is also the need of the hour.

Also, the FDA has granted emergency-use authorizations to hydroxychloroquine and remdesivir to treat the disease. Chloroquine is already approved for treating malaria, lupus and rheumatoid arthritis. Notably, hydroxychloroquine is currently being evaluated in studies for the treatment of COVID-19.

Progress on COVID-19 Vaccines

Several pharma/biotech companies, big as well as small, are speeding up efforts to make a vaccine for COVID-19.

Novavax, Moderna MRNA, Inovio Pharmaceuticals, Pfizer and partner BioNTech have initiated human/clinical studies on a coronavirus vaccine. Earlier this week, Moderna announced initiation of a phase II study on its coronavirus vaccine candidate. J&J (JNJ) and Vaxart plan to initiate clinical study on a coronavirus vaccine in the second half of 2020. Several other vaccine candidates are in pre-clinical stage of development.

In the United States, two organizations, the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) are providing funding to companies involved in making drugs/vaccines. The Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo, has also provided funding of millions of dollars to biotechs including Moderna, Novavax, CureVac and Inovio and several universities to accelerate the development of vaccines against COVID-19.

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Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report GlaxoSmithKline plc (GSK) : Free Stock Analysis Report Vir Biotechnology, Inc. (VIR) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research