Helixmith Announces Topline Results from Double-Blind Placebo Controlled Multicenter Study for TADIOS Involving 100 Subjects Infected with COVID-19

KEY POINTS

• TADIOS was determined to be safe and well tolerated
• Serum levels of IL-1RA changed significantly, a biomarker that has a correlation with severity and mortality during COVID-19 infections
• Improvement in fatigue observed

Excerpt from the Press Release:

LA JOLLA, Calif., Aug. 3, 2022  Helixmith announced topline results today from the double-blind placebo controlled multicenter study for TADIOS involving one hundred subjects infected with COVID-19. This study was conducted in India in compliance with AYUSH guidelines.

TADIOS is Helixmith’s proprietary botanical formulation composed of three plants, which has been developed for the treatment of respiratory disease caused by viruses, microdust, and such. The primary goal of this study was to evaluate safety and tolerability of TADIOS, as well as its effects on efficacy parameters, which included biomarkers and clinical symptoms.

Subjects diagnosed with COVID-19 infection, showing mild to moderate symptoms, were enrolled according to the clinical management guidelines of the Government of India. Subjects were randomized to TADIOS and placebo with a 1:1 ratio in which fifty patients were assigned in each group. TADIOS and placebo were administered in addition to the standard of care in a double-blinded manner. Efficacy parameters were measured after the 10-day treatment maximum per COVID-19 treatment guideline of India. Safety was assessed at 14-day follow up after treatment was completed.

TADIOS was determined to be safe and well tolerated. The TADIOS treated group did not show any difference in adverse events compared to the placebo group, confirming its potential to be developed as a safe botanical treatment for COVID-19 treatment.

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