TrippBio Reports Positive Results from Investigator-Initiated Clinical Trial of TD213 for the Treatment of Mild to Moderate COVID-19 Infections
JACKSONVILLE, Fla. and BOCA RATON, Fla., Nov. 16, 2020 /PRNewswire/ -- TrippBio is dedicated to developing groundbreaking treatments for viral infections, initially targeting COVID-19. TrippBio is developing a patent-pending repurposed FDA-approved drug called TD213. TD213 is administered orally twice daily and works by blocking replication of the SARS-CoV-2 virus and the associated acute inflammatory response to the infection. TrippBio is founded on the scientific research of Ralph Tripp, Ph.D., Georgia Research Alliance Chair and professor at the University of Georgia.
TrippBio is pleased to announce positive interim data from the investigator-initiated study (IIS) to assess the efficacy of TD213 in treating patients with confirmed mild-moderate COVD-19. The study was conducted by Dr. Moti N. Ramgopal of Midway Immunology and Research Center. Outpatients who tested positive using a validated SARS-CoV-2 RNA COVID-19 test were given TD213 twice daily for 14 days and will be followed through day 28.
After 14 days, 90% of enrolled patients receiving TD213 had cleared the virus. Dr. Ramgopal, the principal investigator, stated, "I was very pleased to see that 20% of the patients cleared by day five, and 40% by day ten, as well as the 14-day clearance data. Especially, when compared to the median time of 17.2 days to stop viral shedding reported in a mild-moderate population in a recently published review of 77 studies looking at COVID-19 patients.
An initial review of laboratory tests showed that a critical marker of inflammation, high-sensitive C-reactive protein (hsCRP), improved after four days of treatment in 60% of patients and 90% of patients after 14 days of treatment.
Philip Young, CEO, stated, "We're thankful to the staff at Midway for conducting this study. This data will be an important component of our discussions with the FDA as we pursue our plan to rapidly move into confirmatory studies designed to gain approval of TD213 for the treatment of non-hospitalized patients with mild to moderate infections."
TrippBio believes that TD213 is a promising viral modulator and potentially an important treatment for mild to moderate COVID-19 infections. We are seeking equity crowdfunding to support the manufacturing and clinical trials needed for regulatory approval.
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