Encouraging animal model efficacy data has been published in Journal of Ethnopharmacology
Clinical trial of 100 patients diagnosed with COVID-19 to begin soon in India
TADIOS found to have anti-inflammatory, anti-oxidative activities and therapeutic effects in acute lung injury animal model
January 14, 2021 – Helixmith Co., Ltd. has announced that TADIOS (HX110), a respiratory treatment developed by the company, showed lung damage-suppressing capability in an acute lung injury mouse model. The results have been published in the Journal of Ethnopharmacology. Helixmith plans to conduct a clinical trial in India to assess if TADIOS can be used as a COVID-19 treatment. Helixmith has signed an agreement with a contract research organization (CRO) that has extensive experience and capacities in the conduct of clinical trials in India. The clinical trial will be conducted in accordance with the regulations of the Ministry of AYUSH, India’s traditional medicine regulatory body, and will begin in February with 100 subjects.
Publication Link: https://www.sciencedirect.com/science/article/abs/pii/S0378874121000210
Summary of Publication
TADIOS is a botanical formulation composed of three herbs. Each of the plant species incorporated in TADIOS has been used individually in Asia as a food ingredient and/or medicinal herb for the treatment of various respiratory diseases. Helixmith’s research team found in animal models that, when the three herbs are combined at an appropriate ratio and processed in a specific way, the therapeutic effect can be significantly increased.
Acute respiratory distress syndrome (ARDS) is a respiratory failure produced by uncontrolled excessive inflammation and oxidative stress in the lungs. The causes are diverse, including bacteria, viruses, and environmental chemicals. An acute lung injury mouse model with a high degree of pulmonary inflammation induced by a lipid polysaccharide (LPS) is one of the most frequently used animal models in ARDS studies. In the LPS-induced acute lung injury (ALI) model, lung damage progresses very rapidly and extensively. Effective treatment in this model may indicate the possibility of preventing or treating clinical symptoms in respiratory diseases such as that caused by SARS-CoV-2.
In the described study, the researchers used the LPS-induced ALI model and found that lung damage was significantly inhibited in mice treated with TADIOS. The effects appear to result from the control of excessive production of inflammatory and oxidative molecules such as TNF-alpha, IL-6, IL-1beta and ROS. The potential molecular mechanism underlying TADIOS’ anti-inflammatory and anti-oxidative activities is control of the Nrf2-HO-1 pathway. Thus, rather than acting on SARS-CoV-2 itself, TADIOS may instead prevent or inhibit disease progression upon viral infection through a reduction of inflammatory and oxidative response.
Based on the findings, Helixmith has decided to conduct a double-blind placebo-controlled clinical study on patients diagnosed with COVID-19 to investigate whether TADIOS can prevent or alleviate disease progression.
The upcoming TADIOS clinical trial will be conducted in India, where there is a high rate of COVID-19 infection and unmet medical need. The study will target patients diagnosed with COVID-19 who have mild to moderate clinical symptoms.
The plan is to enroll 100 patients who have been diagnosed with COVID-19 via RT-PCR test. Patients will be randomized 1:1, 50 subjects to the TADIOS group and 50 to the placebo group. TADIOS will be added as an adjuvant to the COVID-19 standard treatment regimen under double-blinded conditions, and its efficacy and safety will be assessed at 10 days and 14 days after administration. Various biochemical indicators, such as TNF-alpha, CRP, IL-6, IL-1ra, Hb, and ferritin, will be measured at 10 days post administration or at the time of discharge if earlier than 10 days. Anti-inflammatory and anti-oxidative activity will also be assessed. Clinical symptom improvement will be determined using an 8-point sequence scale designed by WHO. Quality of life, fatigue, and hospitalization period will be evaluated. The study is expected to take six to eight months once EC approval is obtained at all clinical sites.
COVID-19 Unmet Need
Respiratory damage caused by COVID-19 is known to include extensive inflammatory reactions and oxidative stress. For this reason, treatments aimed at suppressing inflammation through immune control are being developed, but indiscriminate immunosuppressants such as steroids can have safety problems. Therefore, the development of safe and effective treatments is urgently needed.
More than 80% of people infected with COVID-19 are known to be asymptomatic or have mild symptoms, but fatality rates are high for people with underlying conditions such as diabetes and chronic obstructive pulmonary disease. In addition, 3-5% of infected patients are known to develop acute respiratory failure or ARDS; therefore, treatments that can mitigate disease progression or inhibit respiratory damage are needed.
“The individual herbs in TADIOS have historical records of safety and efficacy in Asian countries. Through this clinical trial, we hope to confirm clinical effectiveness of this combination of botanical herbs in improving symptoms of COVID-19 patients,” said Seungshin Yu, CEO of Helixmith.
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 (Phase 2 beginning in late 2020), coronary artery disease, and Charcot-Marie-Tooth disease. The company is listed on KOSDAQ.
Helixmith clinical development and manufacturing activities are based in San Diego, California, where the company co-owns a cGMP-ready DNA production facility, Genopis, Inc., an affiliated CDMO also in San Diego. Genopis serves both Helixmith and external customers in need of plasmid DNA for medical purposes.
Senior Director, Medical Affairs Strategy