Redwood City biotech attacking coronavirus

After completing phase 1 of clinical studies to determine the safety of the drug on healthy volunteers, the company is now entering phase 2 of clinical trials involving people infected by COVID-19. 

“We’re on track to have an interim analysis done at the end of September. Questions we’ll be looking at are: Is the drug effective? Is it safe for the patients we’re treating? We think we’ll be able to expand the study pretty quickly and by the first quarter 2021 have something meaningful for emergency treatments,” said Cleland. 

OP-101 is an anti-inflammatory drug developed over a 15-year-period by two scientists associated with Johns Hopkins University in Maryland. The behavior of the drug is to target overactive macrophages, a cell in the white blood cell family responsible for “going in to chew up foreign cells and remove them,” said Cleland. 

When the lungs become inflamed, macrophages begin eating the foreign contaminate which helps the body level out and develop immunity. But with the novel coronavirus, foreign cells reproduce too quickly to be managed and the body begins to attack itself, resulting in a complication called a cytokine storm. 

These storms can lead to neurological damage and destroy the lining of organs. This damage then enables excessive amounts of fluid to enter passageways resulting in pneumonia and other ailments. Some drugs being used to reverse these reactions attack one type of cytokine protein produced by the macrophage leaving other channels open to continue contamination. OP-101 calms the entire macrophage allowing the body to begin to heal itself, Cleland said. 

“People working on figuring out how to treat the disease realize we need a cocktail. The single approach won’t be successful,” he said. 

Hyperinflammation experienced during COVID-19 infections is similar to that of the flu. During both viruses, a cytokine storm can cause fevers to spike to dangerous levels. A key difference is COVID-19 reproduces far more rapidly than the common flu. Once hyperinflammation is controlled, infections could become much more manageable as well, said Cleland. 

“We could get the rate of deaths down to the rate of the flu and not have a lot of challenges like shelter-in-place. That’s the goal, to get this disease under control. People will still get infected but it would be less severe,” he said. 

While the drug may be used to begin treating patients in cases of emergencies as early as next year, phase three may take an additional year to allow for the drug to be more widely tested amongst a larger sample group.