In December 2019, the COVID-19 pandemic began with a handful of cases that began to shift the world in a way few could have predicted. Two years later, with more than 275 million cases and 5 million deaths worldwide, SARS-CoV-2 continues to evolve and spread.

Throughout the pandemic, the COVID-19 virus has continued to mutate and spawn new variants. Omicron, the most recent and perhaps the most contagious, is unlikely to be the last. These variants may evade the protection conferred from immunization, which makes it crucial to develop prophylactic treatments that target the effects of the virus instead of the virus itself. At Gb Sciences, we are developing one such drug.

Cytokine release syndrome, or CRS, is a severe systemic hyperinflammatory response to infection, and one of the most dangerous complications of COVID-19.  Gb Sciences recently received positive results from the preclinical study of our novel CRS therapies, which demonstrated their potential to reset the body’s immune system after triggering hyperinflammation. Our CRS therapies were designed to reduce the dangerous levels of cytokines triggered by COVID-19 and similar viruses, while preserving the immune functions necessary to fight viral diseases.

Our development-stage therapy was not designed to prevent an infection, or cure late symptoms, but if taken at the first sign of viral exposure, it is designed to reduce the levels of cytokines over the course of the disease so that the person avoids the worst possible outcomes. Simply put, our novel CRS therapy has been designed as a preventative for those who suspect that they have been exposed to any variant of the virus.

The therapy would likely work in this manner: A person exposed to someone with COVID-19 would take the drug for a week while they learn if they are infected. If the person tests positive for COVID-19, our drug was designed to actively reduce cytokine levels, which prevents a ‘cytokine storm’ and the related tissue damage from cytokine storms. If the person is uninfected, the drug’s effects are moot.

Gb Sciences’ CRS therapies were studied last year by Michigan State University researchers. The MSU study found that specific formulations of Gb Sciences’ cannabinoid-containing complex mixtures (CCCM) reduced CRS biomarkers in human immune cells exposed to an inflammatory stimulus, such as viral or bacterial triggers of hyperinflammation. Researchers took immune cells from human donors and co-cultured them together in one of four treatment groups:

• Untreated (no inflammatory stimulus)

• Inflammatory stimulus (to trigger hyperinflammation)

• Control (inflammatory stimulus and all the components from the cannabinoid mixtures except the cannabinoids–so no active ingredients)

• Pre-treatment with the cannabinoid mixture and the inflammatory stimulus

A panel of cytokines and inflammatory markers were then measured from each of these treatment groups, from different immune cell types within the co-cultured cells, at four time points to determine whether Gb Sciences’ cannabinoid mixtures were able to alter the levels of pro-inflammatory cytokines or other inflammatory agents.

This important preclinical study demonstrated that our CCCMs have the potential to preserve key antiviral immune responses while reducing the cytokines that are causing most of the damage in severely ill COVID-19 patients contending with CRS and associated hyperinflammatory conditions, such as macrophage activation syndrome (MAS) and acute respiratory distress syndrome (ARDS). These hyperinflammatory conditions are the leading causes of death in COVID-19 patients.

These preclinical findings suggest that our therapy can reduce or prevent one of the worst aspects of COVID-19, cytokine release syndromes, which makes it invaluable for those who experience breakthrough infections or who are unvaccinated by choice or because of medical preconditions. This is vitally important, because the last two years have taught us that the coronavirus can and will continue to mutate and find new paths to infect the population.

In the bigger picture, the preclinical study’s significance is in demonstrating that our defined ratios of cannabinoids in minimum essential mixtures have the potential to create entirely new medical solutions to address some of our greatest healthcare threats. Our plant-based drug discovery platform is advancing biopharmaceutical research, with novel plant-inspired therapies showing potential as treatments for Parkinson’s disease, heart disease, chronic pain, anxiety, depression, and many other serious conditions. Our next step is to bring these novel therapies into clinical development.

The author, Dr. Andrea Small-Howard, is President and Chief Science Officer, Gb Sciences.