Targeting 640 Adults Aged 50 and Older
Aiming to Determine Optimal Dosage Based on Phase 2 Results
GC Green Cross announced on June 4 that its U.S. affiliate Curevo has completed the enrollment of the first patient in the Phase 2 expansion study of its shingles vaccine, Amezosvatein (project name CRV-101).
This clinical trial was designed based on the results of the previous Phase 2 study and serves as a step to determine the optimal dosage before entering Phase 3. The study incorporates feedback from regulatory authorities and key stakeholders.
The Curevo research team plans to evaluate immunogenicity, adverse reactions, and safety by administering Amezosvatein or the currently marketed vaccine Shingrix® to 640 adults aged 50 and older. In particular, the inclusion of individuals aged 70 and above as a key recruitment group is significant for securing efficacy and safety data for vaccines targeting the elderly population.
Guy De La Rosa, Chief Medical Officer (CMO) of Curevo, stated, "I would like to thank the research team for their efforts to make Amezosvatein a new alternative in shingles vaccination," adding, "The active cooperation of the various research institutions participating in the trial and the high expectations for Amezosvatein are also providing great support."
George Simeon, CEO, emphasized, "Completing the first patient enrollment just two months after raising $100 million (approximately 137.5 billion KRW) in Series B funding demonstrates the outstanding execution and drive of the Curevo team."
Curevo plans to accelerate not only the entry of Amezosvatein into Phase 3 trials but also its commercialization and global regulatory approval strategies.
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