EuBiologics disclosed the results of the domestic Phase 1 clinical trial of its shingles prevention vaccine 'EuHZV injection' on the 21st. No serious adverse events or serious adverse drug reactions were reported during the main study period.

Conducted in 72 Healthy Adults Aged 50-69... Safety Evaluated at Low and High Doses

This clinical trial was conducted to evaluate the safety and tolerability of the low-dose (HZV-1) and high-dose (HZV-2) EuHZV vaccines in 72 healthy adults aged 50 to 69. It was approved by the Ministry of Food and Drug Safety on April 19, 2024, and conducted at Seoul St. Mary's Hospital, Eunpyeong St. Mary's Hospital of the Catholic University of Korea from July 10, 2024 to June 8, 2026.

Subjects were divided into a low-dose group, a high-dose group, and an active control group receiving Shingrix, with each group receiving two vaccinations at 8-week intervals. Safety and immunogenicity were then evaluated up to 52 weeks after the second vaccination.

Adverse Events Occurred After Vaccination... But No Serious Adverse Events or GRADE 3 or Higher

According to the clinical trial results, treatment-emergent adverse events (TEAEs) during the main study period occurred in 24 subjects (100.00%, 193 cases) in the low-dose group, 24 subjects (100.00%, 258 cases) in the high-dose group, and 23 subjects (95.83%, 247 cases) in the Shingrix group. Adverse drug reactions (ADRs) were reported in 24 subjects (191 cases), 24 subjects (256 cases), and 23 subjects (247 cases), respectively.

However, no serious adverse events (SAEs), serious adverse drug reactions (SADRs), medically attended adverse events (MAAEs), adverse events of special interest (AESIs), or immediate adverse events were reported during the main study period. There were also no adverse events assessed as GRADE 3 (severe) or GRADE 4 (potentially life-threatening). Additionally, there were no cases during the main study period in which administration of the investigational drug was discontinued or temporarily interrupted due to adverse events.

Meanwhile, during the follow-up observation period, one serious adverse event corresponding to rotator cuff syndrome was reported in the low-dose group. The company stated that this case was not an adverse drug reaction.

Exploratory Phase 1 Trial... Additional Dose Verification on a Larger Scale in Phase 2

EuBiologics plans to additionally evaluate the safety and immunogenicity of the selected dose in a larger subject population through a Phase 2 clinical trial. The company explained that this Phase 1 trial was an exploratory study that did not test statistical hypotheses, and was not a trial designed to demonstrate efficacy differences between the test and control groups with statistical significance.

uPopLifeScience Holds Commercialization Rights... Domestic Licensing Contract Under Negotiation

uPopLifeScience, a subsidiary in which EuBiologics holds an 80% stake, is the commercialization rights holder of the vaccine and holds contractual licenses for development, manufacturing, and sales using the related technology. EuBiologics holds a right of first refusal regarding domestic development, manufacturing, and sales, but the domestic license has not been finalized, and the company stated that it is currently in negotiations to conclude a related contract.

"Probability of Final Approval for Clinical New Drugs Is About 10%... Investors Urged to Invest with Caution"

Through its investment cautionary notes, the company informed that the statistical probability of a clinical trial drug receiving final approval as a pharmaceutical product is known to be around 10%. It also stated that results during the clinical trial and product approval process may fall short of expectations, and there remains a possibility of changing or abandoning commercialization plans accordingly. Furthermore, the company urged investors to invest carefully after comprehensively considering the investment risks disclosed through periodic disclosures and business reports.