Medical Innovation Exchange

Novartis works on pan-coronavirus pill, eyes 2022 human testing

Unlike some of its Big Pharma peers, Novartis has not been at the forefront of creating new vaccines and treatments against COVID: Now, however, it’s taking its massive R&D budget and targeting not just the current pandemic, but all coronaviruses.

The U.S.-Swiss pharma is working on a main protease (Mpro) inhibitor drug, an early field of study that has been yielding some very preclinical glimmers that it can fight back against SARS-CoV-2.

But Novartis, which is in the preclinical phase for this program, has found that the main protease is not limited to just SARS-CoV-2 but rather is highly genetically conserved across many coronaviruses. The idea, then, is to not just try to fight the current pandemic, but to build a pan-coronavirus platform that can help us fight the next.

Stopping the main protease is a strategy designed to prevent viral replication by ensuring that the virus cannot assemble and use the “copy machine” it needs to reproduce itself.

“We are excited to keep advancing our Mpro inhibitor program, which is progressing very quickly,” Jay Bradner, M.D., president of the Novartis Institutes for BioMedical Research, told Fierce Biotech. “We remain on track to start human testing in 2022.”

The pharma is looking at a prophylactic use before patients start to get too ill to treat, using it in patients who are either in the very early stages of the disease or have been exposed but are awaiting confirmation.

RELATED: Novartis inks deal to manufacture Pfizer COVID-19 vaccines in Slovenia

“We are building a bespoke molecule based on design principles for a coronavirus antiviral: a once-a-day pill that could address many coronaviruses, safe and simple enough for even prophylactic use,” Bradner explained.

“Ideally, such a pill would work on its own, although full eradication of the virus may require combination with existing or future medicines of different mechanisms. A pill with most or all of these characteristics could be highly differentiated from other COVID-19 therapies currently in development.”

He acknowledged that the world has many good working vaccines and is now slowly—but surely—seeing more drugs for COVID becoming available, but added that there is still a need for a new pill as “globally a tremendous unmet need remains.”

“The SARS-CoV-2 virus is still with us and, as omicron has made clear, still mutating. We can also imagine that drug resistance might become a problem in the future. In such a dynamic and global context, there is clearly a need for multiple COVID-19 therapies, just as there is a need for multiple COVID-19 vaccines.”

RELATED: Novartis-partnered DARPin flames out in COVID-19 study, sending Molecular Partners’ stock into nosedive

Novartis didn’t initially jump on the COVID research bandwagon in early 2020 like its peers Gilead Sciences, Pfizer, AstraZeneca and Johnson & Johnson, but it has been in the fight, earlier this year penning a deal to work on production of the Pfizer-BioNTech COVID-19 vaccine to help ramp up supply from 2022.

While this is its first solo effort on a coronavirus pill, it did also pen a partnership with Molecular Partners for a COVID drug, known as ensovibep and formed from the biotech’s DARPin platform, but like so many has hit major speed bumps along the way.

The problem for this and so many drugs was in patients already very sick with the disease; getting to them as early as possible in COVID’s pathway, as it will attempt with its own drug, appears to be the best way forward.

Medical Innovation Exchange

https://www.fiercebiotech.com/biotech/novartis-working-pan-coronavirus-pill-eyes-2022-human-testing

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