Hyundai Bioscience submits phase 3 trial plan for Xafty, targeting high-risk Covid-19 patients

Hyundai Bioscience, which is pursuing emergency use authorization for Xafty as a treatment for patients with mild-to-moderate Covid-19, said Wednesday that it has submitted a phase 3 trial protocol to the Ministry of Food and Drug Safety (MFDS) for high-risk patients only.

High-risk patients are those aged 60 years and older, those with underlying medical conditions, including diabetes, hypertension, cardiovascular disease, chronic heart disease, and chronic lung disease, and immunocompromised individuals 19 years and older, who are being intensively managed by health authorities worldwide because they can become severely ill when infected with Covid-19.

The recent resurgence of Covid-19 has led to a rapid increase in confirmed cases and hospitalizations. More than 65 percent of hospitalized patients are 65 and older. Despite the rising number of cases and hospitalizations in this high-risk population, no treatment can be safely prescribed for this population globally.

Previously approved Covid-19 treatments have multiple contraindications that prevent them from being prescribed to patients already taking contraindicated medications or limit their effectiveness. There is an urgent global need for a treatment that can be safely prescribed to high-risk patients without contraindications, according to Hyundai Bioscience.

In response, the U.S. National Institutes of Health (NIH) conducted a global phase 3 clinical trial of a Japanese-made Covid-19 treatment to develop a treatment that can be prescribed to high-risk patients who cannot take Paxlovid. However, the trial failed to meet its primary endpoint.

The only remaining alternative is Korea’s Covid-19 drug Xafty. Immediately after the NIH announced the global clinical results of the Japanese Covid-19 treatment, Hyundai Bioscience began preparing for phase 3 clinical trials aimed at emergency use authorization (EUA) for high-risk patients.

Xafty has proven its efficacy and safety by rapidly improving 12 symptoms of Covid-19 in 300 mild-to-moderate patients for the previous emergency use authorization.

Notably, after statistical analysis of the treatment effect of high-risk patients separately at the request of the Korea Disease Control and Prevention Agency (KDCA), it was confirmed that Xafty was more effective in high-risk patients taking medications, including diabetes, hypertension, and heart disease.

Based on the results of the previous clinical trial, Hyundai Bioscience announced it has decided to continue with the EUA for treating Covid-19 in mild-to-moderate patients and to conduct a phase 3 clinical trial in high-risk patients only by significantly increasing the number of high-risk patients from 120 (low-dose and high-dose groups and control group, 40 patients in each group) to 290 (test group and control group, 145 patients in each group).

Unlike the previous clinical trial, which included hospitalized patients, this high-risk trial will be conducted on non-hospitalized patients (outpatients), which is expected to result in “rapid clinical progress due to rapid recruitment of subjects and a significant reduction in clinical costs per subject” (20-25 percent compared to the previous trial).

“Paxlovid is a treatment for high-risk patients, but high-risk patients who are taking concomitant contraindicated medications cannot be prescribed Paxlovid, leaving them in a treatment blind spot,” Hyundai Bioscience Vice President Jin Geun-u said. “A Japanese Covid-19 treatment led by the U.S. NIH to develop a treatment for high-risk patients who cannot take Paxlovid has failed to cross the global phase 3 barrier. This leaves Xafty as the only alternative to overcome the urgent need for a treatment for high-risk patients worldwide.”

Hyundai Bioscience CEO Oh Sang-gi said, “Hyundai Bioscience is pursuing emergency approval of Xafty with a two-track approach. We will continue to proceed with the emergency use authorization of the existing treatment for mild-to-moderate patients, and we will quickly conduct phase 3 clinical trials for the EAU of the treatment for high-risk patients. We will cooperate with the MFDS to the fullest extent possible to achieve prompt results.”