GC Biopharma said Monday that its U.S. affiliate, Curevo Vaccine, which specializes in varicella-zoster virus vaccine development, has confirmed that its shingles vaccine CRV-101 was non-inferior to GSK's Shingrix in a phase 2 study.

On Monday, Curevo disclosed the topline results from the phase 2 trial of CRV-101, a non-mRNA adjuvanted vaccine for shingles.

The phase 2 study was conducted in the U.S. with 876 healthy adults aged 50 years and older to evaluate the immunogenicity and safety of CRV-101.

The results, which were compared head-to-head with GSK's Shingrix, demonstrated that CRV-101 was non-inferior to Shingrix and was well tolerated, showing 100 percent of the vaccine response rate (VRR) for CRV-101, compared to 97.9 percent for Shingrix, according to GC Biopharma.

Grade 3 or higher adverse events were not found in the CRV-101 arm, indicating a lower rate of adverse events compared to Shingrix, GC Biopharma said. 

In terms of systemic adverse events, CRV-101 showed 5.5 percent of grade 2 adverse events compared to 19.1 percent of grade 2 and 3 adverse events in Shingrix. For local side effects, there were 3.6 percent of grade 2 adverse events in the CRV-101 arm compared to 25.3 percent of grade 2 and 3 events in the Shingrix arm.

According to market research firm, Evaluate, the global market for shingles vaccines, including the U.S., is expected to grow from $3.7 billion in sales in 2022 to $5.85 billion in 2028.

Curevo said the phase 2 results provided a basis for selecting dose, which will allow it to proceed to phase 3 next year.

"There is a clear unmet medical need globally for a shingles vaccine with improved tolerability and better accessibility," said Dr. William Smith, primary investigator on the CRV-101 study. "CRV-101 had lower rates of solicited local and systemic adverse events compared to Shingrix in this phase 2 trial while showing a comparable immune response. If these data are confirmed in a phase 3 trial, CRV-101 holds great promise in meeting the goal of broadening effective vaccination rates against shingles."

“Fewer than 5 percent of eligible adults in most European countries and China have received both doses of Shingrix,” Curevo CEO George Simeon said. “Two-thirds of adults in the U.S. still need to be immunized against shingles. The entire Curevo team is dedicated to swiftly bringing CRV-101 to global markets.”