Hyundai Bioscience to begin late-state trials for new drug

South Korea’s Hyundai Bioscience announced on Nov. 13 that Vietnam’s Ministry of Health has approved a revised clinical trial plan for CP-COV03, the company’s oral broad-spectrum antiviral drug candidate.

The measure is expected to pave the way for late-stage testing of what could become the world’s first oral treatment for dengue and dengue-like viral illnesses.

The company said the approval covers a formulation change from capsule to granule form.

Hyundai Bioscience noted that the move is intended to improve storage convenience and patient adherence, particularly for patients who have high fever, nausea, or difficulty swallowing, conditions that often make capsule-based medication hard to take.

The granule form can be administered more easily across a wider range of patients.

To ensure smoother recruitment, the number of trial sites has been expanded from one to two, according to Hyundai Bioscience.

The late-stage clinical program consists of a randomized, double-blind, placebo-controlled Phase 2/3 trial involving patients with dengue and dengue-related viral infections such as Zika, Influenza A, and COVID-19.

Hyundai Bioscience noted that Phase 2 would enroll 210 dengue patients to evaluate the drug’s pharmacokinetics, safety, and antiviral efficacy.

Once efficacy is confirmed, it vies to immediately begin discussions with Vietnamese authorities on potential Emergency Use Authorization or conditional approval, similar to measures enacted during the COVID-19 pandemic for vaccines and therapeutics.

Phase 3 will assess improvements in symptom duration and clinical recovery among patients infected with dengue and related viruses, the corporation noted.

According to the World Health Organization, global dengue infections have surged to more than 14.6 million cases in 2024, with over 40 percent of the world’s population in tropical and subtropical regions at risk.

Between 5 and 10 percent of dengue patients progress to severe dengue, and without timely treatment, the fatality rate for severe cases can rise to as high as 20 percent.

No specific antiviral treatment for dengue has been approved to date, leaving patients reliant solely on symptomatic care such as fever management and fluid therapy, Hyundai Bioscience said.

“CP-COV03 has already demonstrated a strong safety profile in large-scale COVID-19 clinical trials,” Hyundai Bioscience CEO Bae Byung-joon said in a statement.

“With this approval in Vietnam, we aim to accelerate global clinical development and move closer to commercializing the world’s first oral treatment for dengue and related viral diseases.”