Prothione capsules were safe and well tolerated
Subjects with mild to moderate COVID-19 symptoms on Prothione experienced more rapid clinical resolution
Patients with moderate to severe symptoms of COVID-19 on Prothione were 4 times less likely to be admitted to the hospital than those on placebo
FRANKLIN, Tenn., June 15, 2022--(BUSINESS WIRE)--Prothione LLC, an innovative, U.S. based pharmaceutical company announced today positive results from a Phase II trial of Prothione capsules for the treatment of mild to moderate COVID-19. The data show that patients assigned treatment with the drug had a reduction in time to clinical resolution as defined by the time to attain 3 consecutive negative RT-PCR tests and a statistically significant decrease in viral load of COVID-19. Prothione was also found to be safe and well tolerated.
Prothione is a pro-glutathione therapy that provides the precursors to help the body produce intracellular glutathione (GSH). The capsules contain three amino acids known to increase intracellular glutathione, reduce oxidative stress, and inhibit inflammatory reactions in patients with COVID-19.
In the trial titled "A Phase 2, Proof of Concept, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of ProthioneTM Capsules for Mild to Moderate COVID-19," Prothione capsules showed a mean change in viral load of COVID-19 from baseline to day 14 of 43,337 c/mL vs 7,039.7 c/mL for placebo (P = .0347). Additionally, there was a marked increase in red blood cell GSH levels from baseline to day 29 in Prothione of 156.9 (N95) vs 107.3 (N83) for placebo.
Ongoing analysis also shows that moderately infected COVID-19 patients appear to have a greater response to Prothione capsules due to lower GSH levels at time of entry into the trial. During this pivotal trial, there was a significant reduction in hospitalizations among Prothione-treated patients, with only one hospitalization compared with four COVID-19 related hospitalizations in patients in the placebo group. This suggests that the drop in viral load helped reduce progression and severity of disease.
The safety profile was unprecedented with no difference or clustering of events for a single system compared to placebo. The risk-/benefit analysis of Prothione is compelling: the ability to dose at all ages without drug interactions or other co-morbidity concerns makes Prothione a novel anti-viral therapeutic in the treatment of COVID-19.
"With its excellent safety profile and low price point, Prothione is poised to save lives and reduce strain on health care systems around the world," said Prothione CEO Laura Lile, MD, RPh.
Recognizing Rwanda’s health care leadership in Africa, Prothione LLC, chose to move drug development clinical trials to the capital city of Kigali. The research was carried out by the Ministry of Health through Rwanda Biomedical Centre in close collaboration with Rinda Ubuzima, a research center partner of the College of Medicine and Health Science of the University of Rwanda.
The trial was conducted during the height of the lockdown in Rwanda at record speed. In just under 4 months, 14,091 in-person COVID-19 positive patient visits were carried out and 21,940 lab tests and biomarkers were performed.
"I’d like to thank our Rwandan research partners for the skillful, rapid, and dedicated execution of this trial," said Dr. Lile. "I cannot say enough about the drive and innovation we have encountered in Rwanda."
Prothione LLC is seeking a partner to complete Phase III trials in the United States. Prothione is a novel SARS-CoV-2 antiviral with the potential to treat all mRNA viral syndromes. HIV-positive patients with mild to moderate symptoms from COVID-19 on Prothione capsules experienced dramatic drops in HIV viral load. MarketQuest forecasts the global market for antivirals to reach $61.67 billion by 2028.
Prothione LLC presented results of the Phase II clinical trial to a wide range of researchers, healthcare workers, government officials and non-government organizations in Kigali on June 3. The presentation will be available at www.prothionecaps.com, where it is also possible to view the abstract titled "A Phase 2, Proof of Concept, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of ProthioneTM Capsules for Mild to Moderate COVID-19."
Prothione LLC is an innovative pharmaceutical company based in Franklin, Tennessee. The company is committed to the science of innate health that provides affordable and high-quality wellness products to all and is focused on addressing some of the world’s most challenging healthcare problems with patented therapeutics. For more information or to contact Prothione LLC, please visit www.prothionecaps.com.
Prothione is a novel antiviral with high clinical efficacy and pan- COVID-19 design properties that maintain activity with a favorable safety profile. The capsules provide the precursors to help the body produce intracellular GSH. Prothione contains three amino acids known to increase intracellular glutathione, reduce oxidative stress and inhibit inflammatory reactions during COVID-19.
The over-the-counter version of Prothione, Immune Formulation 200®, also known as IF200®, is available for sale in the United States and was recently approved by the Rwanda FDA. To learn more about Immune Formulation 200®, visit IF200.com.
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