Does the FDA Rollback Of Regeneron And Eli Lilly COVID Treatment EUAs Signal A Need To Look Beyond Monoclonal Antibodies? NanoViricides, Inc. Looks To Meet This Need With A New Approach

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In January, the U.S. Food and Drug Administration (FDA) revoked its emergency use authorization (EUA) of two COVID-19 antibody treatments that had initially been granted emergency use authorization by the agency in November 2020. The announcement comes after a review of the latest data showed that neither antibody treatment is especially effective against Omicron, which now accounts for an estimated 99% of new cases. 

Monoclonal antibodies work by targeting the spike protein on a virus particle. With each variant, that spike protein is a little different. In Omicron’s case, it’s a lot different. A  study in Nature found that the variant contains over 30 mutations in the spike protein. While that’s made it easier for tests to distinguish it from other variants, it’s also made it more resistant to both vaccines and antibody treatments. Some experts are concerned that as new variants emerge under the selection pressure of vaccines and antibodies, they will progressively possess increased resistance.  

A Need to Look Beyond Antibodies

To get beyond this problem, doctors need drugs that a virus can’t develop resistance to through mutations. From one developmental-stage pharmaceutical company’s perspective, the answer lies in targeting the virus in a different fashion altogether. 

NanoViricides Inc. NNVC is developing an antiviral, NV-CoV-2, that mimics the cell’s binding site to which the virus spike protein binds. No matter how much the virus mutates, it binds to the same receptor on the human cell in the same way. By mimicking the virus binding site on the receptor, the antiviral drug would remain effective in spite of mutations. Once attached to the binding site, this antiviral engulfs the virus, stopping it from spreading. Because binding sites stay the same throughout mutations, this nanoviricide drug  could potentially work as a broad-spectrum, pan-coronavirus drug. Therefore remaining effective against future variants. 

What’s more, unlike the antibody treatments that require costly and cumbersome infusion administration, the NanoViricides drug will reportedly be available as a gummy that you simply put in your mouth and allow to disappear into your body…especially attractive to children and the elderly.

Solving Decreased Potency and Supply Chokeholds With a New Approach

The two monoclonal antibody treatments that were just revoked by the FDA are each a cocktail of two antibodies . REGN-CoV2 is a mixture of casirivimab and imdevimab manufactured by Regeneron Pharmaceuticals Inc. REGN while bamlanivimab and etesevimab are manufactured by Eli Lilly and Co. LLY.

Both use laboratory-made proteins that mimic the body’s own immune system which generates antibodies in response to harmful infections and diseases that it encounters. For patients who have not built up enough of the specific antibodies needed to fight COVID, the lab-made antibodies are meant to give the immune system a head start.

While such antibodies can be helpful initially, their potency diminishes as the virus mutates, requiring ever-larger doses of the drug to achieve the same level of virus-fighting effects.

That’s what happened with Eli Lilly’s and Regeneron’s drugs. A study published in Nature in December showed that the two drugs were incapable of cutting the viral replication in half, even at extremely high doses. 

The same study also tested sotrovimab, another monoclonal antibody manufactured by GlaxoSmithKline plc GSK and Vir Biotechnology VIR, which is still authorized by the FDA. However, it only barely met the threshold for reducing the virus level to half. Doctors will need to use a dose of sotrovimab three times greater than that used against previous variants to have any potency against Omicron.

With the supply of this treatment already so scarce that many hospitals have been forced to ration what little they have, even creating algorithms for deciding which patients get treatment, the fact that now three times as much to treat a single patient is needed will likely exacerbate that problem.

Although the announcement is recent, the FDA had already been slowly rolling back the use of these antibody treatments since early last year, as both drugs carry the risk of anaphylaxis (allergic reaction), dizziness, pain, bleeding, and possible infection at the infusion site — risks that now arguably outweigh the potential benefit.

NanoViricides, Inc is optimistic that its novel drug could help end the race to develop new vaccines and new antibody treatments for each future variant of COVID-19.

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