Preclinical Efficacy and Safety Studies of Formulation SSV-003, a Potent Anti-Viral Herbal Formulation

BACKGROUND: Recent viral pandemics have challenged the global scientific community to immediately develop new therapies. The fastest approach to develop these is to explore natural products for their efficacies and repurposing of already approved molecules. Keeping global emergency in view, researchers at Shreepad Shree Vallabh SSV Phytopharmaceuticals developed the Curvic(TM) (SSV-003) formulation, comprising of curcumin, vitamin C, vitamin K2-7, selenomethionine and Zinc. METHODS: Researchers have systematically studied the SSV-003 formulation for its in vitro efficacy against influenza A virus (H1N1) (ATCC(®) VR-219™) and human beta coronavirus (ATCC(®) VR1558™) using MDCK & HCT-8 cell lines, respectively, in vivo efficacy studies of SSV-003 on influenza A virus infected Balb/c mice, and acute toxicity studies as per OECD guidelines. RESULTS: Formulation SSV-003 showed potent antiviral activities against both the selected virus strains. Its IC(50) was significantly lessthan ribavirin against influenza A-H1N1-VR219, with no cytopathic effect. SSV-003 showed IC(50) of 2.26 µg/mL against human beta coronavirus, which was near to the IC(50) of ribavirin (2.25 µg/mL) and was less than remedisivir (6.23 µg/mL) with no cytopathic effect. In-vivo studies in an influenza A virus infected mice model showed a significantly higher TCID50 value in the infected control group as compared to test groups. Animals treated with SSV-003 showed a dose dependent decrease in TCID50. Formulation SSV-003 at the dose of 500, 1,000, and 1,500 mg/kg body weight showed 85.9%, 94.6%, and 95.1% decreases in infection as compared to the infected control group. Dose-dependent significant increases in CD4+, CD8+ counts, IgG and IgM levels were observed in SSV-003 treated groups as compared to the infected control group and remedisivir treated group. In the acute oral toxicity study, no mortality or morbidity was observed. CONCLUSION: The data from these preclinical studies provide strong evidence of potent and safe antiviral and immunomodulatory activity of SSV-003.