Clinical trial approved by the FDA starting in February
A Rutgers scientist has invented an early treatment for COVID-19 to prevent severe complications and hospitalizations in patients with prediabetes and diabetes by increasing beneficial bacteria in the gut and reducing organisms that cause coronavirus.
The treatment – created by researcher Liping Zhao – was given the Investigational New Drug status by the Food and Drug Administration with Phase 2a trial starting Feb. 8. While the treatment, NBT-NM108, does not target the coronavirus directly, it does help to create stable foundation for a healthy digestive tract.
“COVID-19 patients with pre-existing conditions such as obesity and type 2 diabetes suffer three to four times higher mortality rate than the average patient population,” said Zhao, professor and Eveleigh-Fenton Chair of Applied Microbiology of the Department of Biochemistry and Microbiology at the School of Environmental and Biological Sciences. “Overgrowth of opportunistic pathogens in the gut of diabetic or prediabetic patients may drive the more severe form of COVID-19. Such pathogens can contribute to the cytokine storm and sepsis, which are the major causes of mortality in these high-risk patients.”
Researchers will begin recruiting patients with diabetes and prediabetes who have tested positive for coronavirus, or are awaiting test results, and are within seven days of onset of COVID-19 symptoms. They hope to have results from the initial study by April.
Zhao has shown in previous studies that proper microbiome nutrition can increase good bacteria in the digestive track of those with type 2 diabetes. When good bacteria were restored, opportunistic pathogens in the gut were reduced to low levels. While the new treatment does not directly target the coronavirus, the scientists believe that a reduction of these pathogens may lead to decreased levels of inflammation and also reduce risk for complications such as bacterial sepsis.
“Controlling the gut microbiota in a way that doesn’t allow the overgrowth of pathogens in the gut could become a very important component of the COVID-19 care,” said Zhao.
The participants for the clinical trial will be recruited by the University of South Florida as part of a collaboration and partnership with Rutgers. The day-to-day measurements and samples will be handled by Liping Zhao’s Lab at Rutgers through an online patient managing platform. The early treatment of the gut microbiota with Zhao’s formula will be a home-based intervention for patients with mild to moderate symptoms.
This clinical trial is sponsored by a Rutgers startup, Notitia Biotechnologies, a next-generation microbiome biotherapeutic company that develops innovative products for patients and the general public.
“We have the vision that everyone can live a long and healthy life by keeping our gut microbiome to the healthiest possible status for the longest possible time. Notitia’s mission is to help everyone achieve a healthy gut microbiota by protecting or restoring the foundation guild of the gut microbial forest,” said Jeffery Zhao, cofounder and CEO of Notitia Biotechnologies.
This article originally appeared in Rutgers Today.