Helixmith Announces 50% Enrollment in its Clinical Trial for COVID-19, involving TADIOS

SAN DIEGO, Dec. 1, 2021 /PRNewswire/ -- Helixmith Co., Ltd. has announced that 50 subjects have been enrolled in its double-blind placebo controlled COVID-19 clinical trial involving 100 subjects. The investigational product is called TADIOS, which is a proprietary botanical treatment. The clinical trial is being conducted in India in accordance with the regulations of the Ministry of AYUSH, India's traditional medicine regulatory body. India has a high rate of COVID-19 infection and unmet medical need.

The ongoing TADIOS clinical trial is being conducted in four trial sites. The trial is targeting patients diagnosed with COVID-19 who have mild to moderate clinical symptoms. Patients are being randomized 1:1, 50 subjects to the TADIOS group and 50 to the placebo group. TADIOS is being orally administered as an adjuvant to the COVID-19 standard treatment regimen under double-blinded conditions, and its efficacy and safety are assessed at 10 days and 14 days after administration. Various biochemical indicators, such as TNF-alpha, CRP, IL-6, IL-1Ra, Hb, and ferritin, are being measured at 10 days post administration or at the time of discharge, if earlier than 10 days. Anti-inflammatory and anti-oxidative activities are also being assessed. Clinical symptom improvement is determined using an 8-point sequence scale designed by the WHO. Quality of life, fatigue, and hospitalization periods are also evaluated.

In pre-clinical studies, TADIOS (HX110) has shown to significantly inhibit lung damage in an acute lung injury mouse model. The therapeutic effects appeared to result from the control of excessive production of inflammatory and oxidative molecules such as TNF-α, IL-6, IL-1β and ROS. The potential molecular mechanism underlying TADIOS' anti-inflammatory and anti-oxidative activities is its control of the Nrf2-HO-1 pathway. Thus, TADIOS appears to prevent or inhibit disease progression upon viral infection through a reduction of inflammatory and oxidative response. The results of these studies were published in the Journal of Ethnopharmacology.

Publication Link: https://www.sciencedirect.com/science/article/abs/pii/S0378874121000210

About Helixmith Co., Ltd.

Helixmith is a gene therapy company based in Seoul and San Diego, developing new and innovative biopharmaceuticals to tackle previously untreated diseases. The company has an extensive gene therapy pipeline, including a CAR-T program targeting several different types of solid tumors and an AAV vector program targeting neuromuscular diseases. Engensis (VM202), the most advanced pipeline candidate, is a plasmid DNA therapy being studied for diabetic peripheral neuropathy, diabetic foot ulcers, claudication, amyotrophic lateral sclerosis, coronary artery disease, and Charcot-Marie-Tooth disease. The company is listed on KOSDAQ.

SOURCE Helixmith USA Inc.