pharm edaily

[Yu Jin-hee, Edaily Reporter] SEOUL, South Korea-Hyundai Bioscience has officially launched a global Phase 2/3 clinical trial of its oral COVID-19 treatment, Xafty, as part of its strategy to prepare for the ongoing resurgence of the virus and potential future pandemics.

The company announced on May 23 that the international trial will take place across several Asian countries, including the Philippines, Thailand, Indonesia, India, Vietnam, Taiwan, and Singapore. The study will evaluate the efficacy and safety of Xafty, a granule formulation designed to enhance patient adherence, in high-risk populations such as those with chronic diseases.



This multinational trial is based on strong clinical outcomes observed in Korea. In a domestic trial involving patients who began treatment within three days of symptom onset (the mITT population), Xafty reduced symptom duration by an average of 3.5 days, meeting global benchmarks for efficacy. Notably, in patients with underlying conditions such as hypertension and diabetes, symptom improvement was accelerated by as much as 5.5 days-highlighting Xafty’s competitive edge over existing therapies.

Xafty had previously demonstrated significant benefits according to U.S. FDA criteria for COVID-19 treatments, showing a meaningful improvement across 12 key symptoms and a higher proportion of patients reporting sustained relief lasting over 48 hours, compared with placebo.

Beyond clinical efficacy, Xafty is touted for its competitive advantages in pricing, ease of administration, and universal applicability without contraindications. During trials, the treatment showed no serious adverse drug reactions and was safely co-administered with common medications for hyperlipidemia, hypertension, and diabetes-unlike many current COVID-19 antivirals, which have over 30 contraindicated drugs.

Currently, only three oral COVID-19 treatments are globally authorized: Pfizer’s Paxlovid, Merck’s Lagevrio, and Shionogi’s Xocova. However, Xocova remains approved only in Japan, Paxlovid poses significant drug interaction risks, and Lagevrio‘s European approval was withdrawn over safety concerns.

With the resurgence of COVID-19 across parts of Asia despite high vaccination rates, driven by reinfections and viral mutations, experts argue that vaccines and current treatments are no longer sufficient. Xafty is positioned as a next-generation antiviral that could help fill this gap. Unlike conventional antivirals that target a single viral protein, Xafty works through an autophagy mechanism-disrupting viral replication and enhancing the body’s immune response to eliminate infected cells. This mechanism has demonstrated effectiveness against major variants including Delta and Omicron.

“COVID-19 isn’t over, especially for vulnerable populations like the elderly and those with chronic illnesses, who urgently need viable alternatives,” said Jin Geun-woo, CEO of Hyundai Bioscience. “Xafty has already proven both efficacy and safety in domestic trials and represents the most practical treatment option currently available.”

He added, “Through our global development efforts, particularly aimed at regions with limited healthcare access, we aim to contribute meaningfully to preventing future pandemic cycles.”