Helixmith said it has begun the clinical trials of its natural extract-based Covid-19 drug TADIOS (HX110) with infected patients in India by giving its first dose on Thursday.
The first patient to receive TADIOS was enrolled in the Sparsh Super Specialty Hospital Bangalore, India.
The company plans to recruit 100 patients for the four planned studies in clinical institutions in the South Asian country where new infections are occurring explosively, saying it expects few difficulties recruiting subjects. India recently recorded more than 300,000 newly infected people and 2,000 deaths a day.
Helixmith will analyze the efficacy, safety, and tolerability of TADIOS in the clinical trials to confirm whether it could treat Covid-19 patients. One of the endpoints is whether the botanical drug candidate could effectively prevent patients from developing severe symptoms.
TADIOS is a botanical formulation composed of three herbs developed to treat respiratory diseases caused by viruses and fine dust.
Helixmith's research team discovered that TADIOS has effectively worked on acute lung disease in animal models and published the study results in the Journal of Ethnopharmacology in January.
"We received approval for conducting clinical trials in India back in January, but the study has been delayed due to the country's briefly paralyzed medical system due to rapid increase in the number of infected people," Helixmith CTO Yu Seung-shin said.
Helixmith CEO Kim Sun-young said, "We urgently need therapies for the Covid-19 regardless of the vaccine as it could show different efficacy among people due to emerging variant strains."
The vaccine may not work for everyone, so medical professionals need available Covid-19 drugs just as they use Tamiflu in addition to flu vaccines."