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

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.

In terms of efficacy, IL-1RA biomarker showed a statistically significant difference and improvement was demonstrated in one of the fatigue-related questionnaires. IL-1RA levels were higher by more than 3-fold in both groups, but the TADIOS treatment group showed a lower level at 2 weeks after the end of administration, compared to the placebo group (p<0.05). It has been reported that IL-1RA is maintained at elevated levels in blood during COVID-19 infection, and its level has a close correlation with the severity and mortality of infection. While known to regulate excessive inflammation, it is also present at elevated levels in a variety of pathologic conditions, such as obesity and rheumatoid arthritis, as well as at the severe stage of COVID-19 infection. Therefore, reduction of IR-1RA by taking TADIOS suggests its possibility of preventing or inhibiting the progression of symptoms caused by COVID-19 infection to severe illness. Among the six biomarkers measured, serum levels of CRP, ferritin, TNF-a and the level of hemoglobin in whole blood were all within the normal range in both groups. and no difference was shown between the two groups.

TADIOS showed some improvement in fatigue, a common symptom in individuals with COVID-19 infections. In one of the questionnaires testing "I am easily fatigued," TADIOS-administered subjects showed statistically significant improvement vs placebo group, two weeks after treatment (p<0.05).

Helixmith is planning to present full data at either an academic conference or in a journal publication upon the completion of the analysis.

A variety of vaccines and medicines have been developed for COVID-19. However, there are still high unmet medical needs in this area, due to continuing emergence of variants and breakthrough infections. Even in Korea where more than 60% of the population has been fully vaccinated, infections and disease progression to symptomatic stages are still occurring at a high frequency. We believe that TADIOS could be used as a 'niche" therapeutic for those who need a safe and well tolerated product with convenient access. Depending on the country, TADIOS may be regulated as a botanical drug or nutraceutical.

About Helixmith
Helixmith is a clinical-stage gene therapy company headquartered in Seoul, Korea, developing new and innovative biopharmaceuticals to address previously untreated diseases, and is listed on the KOSDAQ. 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 painful diabetic peripheral neuropathy, diabetic foot ulcers, claudication, amyotrophic lateral sclerosis, coronary artery disease, and Charcot-Marie-Tooth disease.

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Jennifer Guzman
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SOURCE Helixmith USA Inc.