- Positive data from 876-patient head-to-head trial versus Shingrix^® shows amezosvatein met the primary immunogenicity endpoint, eliciting a robust immune response non-inferior to Shingrix, including a 100% vaccine response rate

-- Amezosvatein also met the primary safety endpoint, with lower local and systemic adverse events in this trial compared to Shingrix

-- Amezosvatein to enter global Phase 3 trials in 2024

Amezosvatein met all primary endpoints in the randomized, controlled, observer-blind Phase 2 trial, including demonstrating non-inferiority to Shingrix as measured by humoral immune response. Amezosvatein also exhibited lower rates of solicited local and systemic adverse events in this Phase 2 trial. Based upon these results, Curevo will advance amezosvatein into global Phase 3 trials in 2024 to address a market for shingles vaccination currently exceeding $4 billion.

The co-primary endpoint of the Phase 2 trial was humoral immune responses one month after the second vaccine dose (Day 84). This primary immunogenicity endpoint was met as participants’ immune responses to amezosvatein were non-inferior to participants’ immune responses to Shingrix. Additionally, amezosvatein’s Vaccine Response Rate was 100.0% compared to Shingrix at 97.9%.

The co-primary safety endpoint was also met, with amezosvatein demonstrating lower rates of solicited local and systemic adverse events in this Phase 2 trial. This was especially apparent when comparing higher grades of solicited local and systemic adverse events occurring within seven days of each dose. If confirmed in a Phase 3 trial, this would represent a significant advantage for amezosvatein since higher-grade adverse events interfering with daily activities are of particular concern to those considering being vaccinated for shingles.

“Despite Shingrix being available for several years, vaccine coverage rates remain disappointingly low,” said Dr. Guy De La Rosa, Curevo’s Chief Medical Officer. “A growing body of evidence suggests tolerability issues contribute to both vaccine hesitancy and avoidance of the required second dose. Amezosvatein was developed specifically to provide high vaccine effectiveness and best-in-class tolerability. We are very excited by these Phase 2 data.”

At the dose chosen for Phase 3 trials, participants receiving amezosvatein reported zero Grade 3 solicited local or systemic adverse events. Grade 2 solicited systemic side effects were reported by 5.5% of participants receiving amezosvatein versus Grade 2 and Grade 3 side effects reported by 19.1% of those receiving Shingrix. Grade 2 solicited local side effects were reported by 3.6% of participants receiving amezosvatein versus Grade 2 and Grade 3 side effects reported by 25.3% receiving Shingrix. Grade 2 and 3 local and systemic side effects are those most likely to interfere with daily activity and are a key contributor to vaccine hesitancy and dose avoidance.

“There is a clear unmet medical need globally for a shingles vaccine with improved tolerability and better accessibility,” stated Dr. William Smith with the Alliance for Multispecialty Research, the primary investigator on this Phase 2 trial and a board-certified physician who has been involved in more than 1,900 clinical trials over the last 35 years. “Amezosvatein 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, amezosvatein holds great promise in meeting the goal of broadening effective vaccination rates against shingles, a serious medical condition capable of causing significant, long-term disruption in adult populations.”

“Fewer than 5% of eligible adults in most European countries and China have received both doses of Shingrix,” noted George Simeon, Curevo’s Chief Executive Officer, “and two thirds of adults in the USA still need to be immunized against shingles. The market opportunity in shingles is large and underserved with only a small fraction of the over $350 billion global addressable market currently vaccinated. The entire Curevo team is dedicated to swiftly bringing amezosvatein to global markets.”