[Edaily Reporter KIM SAE-MI ] EuBiologics Co., Ltd.(206650)has announced the results of the domestic Phase 1 clinical trial for its shingles vaccine candidate “EuHZV,” currently under development, and is moving forward with Phase 2 trials. In subsequent clinical trials, the company plans to verify the immunogenicity non-inferiority of the vaccine compared to the existing shingles vaccine “Shingrix.”

EuBiologics Co., Ltd. announced the results of the Phase 1 clinical trial for EuHZV, conducted on 72 healthy adults aged 50 to 69, on the 21st. The company also stated that it submitted an Investigational New Drug (IND) application for the Phase 2 clinical trial to the Ministry of Food and Drug Safety on the 18th of last month.

The Phase 1 clinical trial, the results of which were recently released, was conducted to evaluate the safety and tolerability of the low-dose and high-dose groups of EuHZV. GSK’s shingles vaccine “Shingrix” was used as the control.

The clinical trial was conducted at Eunpyeong St. Mary’s Hospital of the Catholic University of Korea from July 2024 through June of this year. Participants were assigned to the low-dose group, high-dose group, and Shingrix control group—24 participants in each—and received two doses of the vaccine 8 weeks apart.

During the primary study period, adverse events following vaccination were reported in 24 participants (100%) in the low-dose group, 24 participants (100%) in the high-dose group, and 23 participants (95.83%) in the Shingrix group. The incidence of drug-related adverse reactions was 100%, 100%, and 95.83%, respectively.

The main local adverse events included pain, tenderness, and erythema, while systemic adverse events such as muscle pain, fatigue, and headache were reported. In the high-dose group, tenderness and pain occurred in all study participants, while in the low-dose group, pain was reported in 95.83% and tenderness in 91.67% of participants.

No serious adverse events or serious adverse drug reactions were reported during the main study period. No severe (GRADE 3) or potentially life-threatening (GRADE 4) adverse events occurred. During the follow-up period, one serious adverse event was reported in the low-dose group, but it was assessed as unrelated to the vaccine.

This clinical trial was an exploratory study designed to confirm the safety of the vaccine upon its first administration in humans; therefore, no statistical hypothesis testing was conducted to assess differences in efficacy between the treatment and control groups. Consequently, these results alone cannot be used to determine whether the vaccine is superior to Shingrix in terms of preventive efficacy or immunogenicity.

In addition, EuBiologics Co., Ltd. submitted an Investigational New Drug (IND) application for the Phase 2 clinical trial of EuHZV to the Ministry of Food and Drug Safety on the 18th of last month.

The Phase 2 clinical trial is scheduled to be conducted at six hospitals in South Korea with 150 healthy adults aged 50 and older. In the Phase 2 clinical trial, participants will be randomized in a 1:1:1 ratio to the EuHZV intermediate-dose group, the EuHZV high-dose group, and the Shingrix control group. The primary objective is to confirm the non-inferiority of immunogenicity compared to Shingrix by comparing the geometric mean titer (GMT) of anti-gE antibodies at the 4-week mark following two vaccine doses administered 8 weeks apart.

The trial is scheduled to last 15 months from the date of approval by the Institutional Review Board (IRB). Participants will be followed up for 26 weeks after the second dose to evaluate immunogenicity and long-term safety.

Meanwhile, the commercialization rights for EuHZV are held by U-Pop Life Sciences, a subsidiary in which EuBiologics Co., Ltd. holds an 80% stake. EuBiologics Co., Ltd. holds a right of first refusal regarding domestic development, manufacturing, and sales; however, domestic marketing rights have not yet been finalized. The company is currently in discussions with U-Pop Life Sciences to sign an agreement securing domestic marketing rights.