GC Green Cross affiliate Curevo "Excellent Tolerability in Topline Results of Shingles Phase 2 Clinical Trial"

GC Green Cross announced on the 8th that its U.S. affiliate Curevo Vaccine is developing a shingles vaccine, 'CRV-101,' and has released positive Phase 2 clinical trial results.

The disclosed data are topline results from a clinical trial directly comparing CRV-101 with the industry-leading shingles vaccine 'Shingrix' by GSK. CRV-101 demonstrated non-inferiority and superior tolerability compared to Shingrix, meeting all primary endpoints.

Curevo conducted the trial to evaluate the immunogenicity and safety of CRV-101 by administering two doses at two-month intervals to 876 healthy adults aged 50 and older, divided into two vaccine groups.

As a result, CRV-101 met the primary endpoint by proving non-inferiority to Shingrix in humoral immune response. The vaccine response rate of CRV-101 was 100%, higher than Shingrix's 97.9%.

Additionally, no grade 3 or higher systemic or local adverse events occurred in the CRV-101 group, and the incidence rates of systemic and local adverse events were lower than those of Shingrix, fulfilling the co-primary endpoint.

Specifically, regarding systemic adverse events, grade 2 adverse events occurred in 5.5% of the CRV-101 group, whereas grade 2 and 3 adverse events appeared in 19.1% of the Shingrix group. For local adverse events, grade 2 events occurred in 3.6% of the CRV-101 group, compared to 25.3% grade 2 and 3 events in the Shingrix group. These results demonstrate that CRV-101 has superior tolerability and safety compared to Shingrix.

Curevo stated that the Phase 2 results provided a basis for dose selection and that they plan to proceed with Phase 3 clinical trials next year.

Dr. William Smith, the principal investigator of the trial, said, "There is an unmet medical need worldwide to improve the tolerability and accessibility of shingles vaccines. If CRV-101 shows lower adverse event rates and comparable immune responses to Shingrix in Phase 3, it could effectively expand shingles vaccination."

George Simon, CEO of Curevo, said, "Only about 5% of eligible adults in most European countries and China receive the second dose of Shingrix. Given the significant opportunities in the global market, we will do our best to ensure CRV-101 is rapidly launched worldwide."

Meanwhile, CRV-101 is a premium shingles vaccine developed using a recombinant gene technology with an adjuvant. It is designed to minimize adverse event risks and induce optimal immune responses. According to Evaluate Pharma, a global market research firm, the shingles vaccine market is expected to grow from $3.7 billion (approximately 4.8 trillion KRW) in 2022 to $5.85 billion (approximately 7.6 trillion KRW) by 2028, including the U.S. market.

This content was produced with the assistance of AI translation services.