Bolder BioTechnology says MS drug candidate could be used for COVID-19

BOULDER — Eight-person drug development outfit Bolder BioTechnology Inc. said its multiple sclerosis drug candidate showed early promise as a potential treatment for COVID-19.

The Boulder company said Tuesday that the drug candidate designated as BBT-032 was able to inhibit 85% to 100% of COVID-19 viral replication at low doses when tested on healthy cells within a petri dish.

BBT-032 is part of a class of drugs known as interferons, which generally induce cells to create proteins that fight viral infections and reduce inflammation caused by diseases like AIDS, hepatitis C and certain types of cancer.

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Bolder BioTechnology president Joe Cox told BizWest that the drug could be used both as a treatment for early-stage COVID patients to slow down the virus’ replication and as a preventative measure for medical workers treating patients.

If approved for clinical study by the U.S. Food and Drug Administration, Bolder BioTechnology would be the only U.S. company researching interferons as a treatment for COVID-19.

While COVID-specific clinical studies of the drug have occurred in Hong Kong and China, the U.S. National Institutes of Health currently recommends against using interferons for severe COVID patients because the drug’s side effects of enhancing flu-like symptoms could further harm critical-care patients.

The NIH also says interferons were ineffective against severe cases of earlier coronaviruses such as MERS and SARS.

Cox said the company plans to file an investigational new drug application with the FDA by the end of the year which, if approved, would allow the company to start testing the drug on healthy volunteers in a Phase I clinical trial.

The earliest-case timeline would be if the FDA grants a narrow, emergency use authorization for the drug midway through 2021, he said.

It’s possible that authorization may come after the world’s largest drug companies land approval for a myriad of COVID vaccines currently in late-stage trials, but Cox said BBT and interferons like it could serve as off-the-shelf treatments for future diseases because their mechanisms of action may fight off multiple types of ailments.

“The beauty of what this protein does, stimulating your cells to resist viruses… it works against this particular virus, but it should work against lots of different viruses,” he said.

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