Notitia Biotechnologies company announces expansion of study population for Covid-19 phase 2 study (COVGUT20) for NBT-NM108

After months of preparation, Notitia Biotechnologies Company (Notitia) announced that its COVID-19 Phase 2 study (COVGUT20) for NBT-NM108 has been given support by the Food and Drug Administration (FDA) to expand its study population to all symptomatic COVID-19 patients.

"Previously, our trial focused on COVID-19 patients with type 2 diabetes and prediabetes. Now with this timely expansion to our study population, we can help more people and test NBT- NM108’s efficacy not just for diabetic patients, but for anyone with COVID-19 symptoms,” said Jeffrey Zhao, Co-founder and CEO at Notitia.

NBT-NM108 was created by Rutgers University professor Dr. Liping Zhao and was given the Investigational New Drug status by the FDA as a potential treatment for early-stage COVID-19. The botanical-based formula works to prevent severe complications and hospitalizations in COVID-19 patients by increasing the beneficial bacteria in the gut and reducing overall inflammation in the body.

Previous studies have also found that the beneficial bacteria in the gut can also produce short-chain fatty acids (SCFAs), critical to the hosts’ antiviral immunity. NBT-NM108 can significantly increase the SCFAs in the body and reduce inflammation caused by the dangerous pathogens in the gut.

“Overgrowth of opportunistic pathogens in the gut has been shown to drive a more severe form of COVID-19. Such pathogens can contribute to the cytokine storm and sepsis, which are the major causes of mortality in COVID-19 patients,” said Dr. Zhao, professor and Eveleigh-Fenton Chair of Applied Microbiology of the Department of Biochemistry and Microbiology at the School of Environmental and Biological Sciences.

Notitia is working with collaborators from Rutgers University and the University of South Florida to recruit patients in New Jersey and Florida who have either tested positive for coronavirus or are awaiting test results and are within seven days of onset of COVID-19 symptoms.

Compared to other drugs and therapies, NBT-NM108 does not target the virus itself, making it suitable for all COVID-19 variants. It can also be self-administered by patients at home, and it is also safer than other drugs, thanks to its naturally based botanical formulation.

To sign up for the clinical trial, patients can visit https://notitia.studyenrollment.com, the study is also registered on clinicaltrials.gov under the access number NCT04540406.

About Notitia Biotechnologies Company:

Notitia Biotechnologies Company (Notitia) is a next-generation microbiome biotherapeutic company that unlocks gut microbiome data to develop innovative products and therapies for patients and the general public. The company uses a proprietary reference-free Foundation Guild R&D platform to discover novel bacterial players and create products focused on ecologically restoring the gut ecosystem. Based near Princeton, New Jersey, the company was founded in 2019 by Jeffrey Zhao, Chief Executive Officer, and Dr. Liping Zhao. To learn more, please visit https://www.notitiabio.com