[Asia Economy Reporter Lee Gwan-joo] Vaxxas Technologies in the United States announced the interim results of the Phase 1 clinical trial of the patch-type influenza vaccine 'MIMIX-Flu,' jointly developed with GC Green Cross, on the 14th (local time).
MIMIX-Flu is a product that combines GC Green Cross's influenza vaccine antigen with Vaxxas's patch-based subcutaneous drug delivery system.
This study was conducted to evaluate the safety, reactogenicity, tolerability, and immunogenicity of the drug compared to a placebo group in healthy adults aged 18 to 39. Participants wore the vaccine patch for 5 minutes, and severe adverse reactions caused by the vaccine patch were better compared to traditional vaccines delivered by syringe.
On day 57 after vaccination, the seroconversion rates for the two doses used in the clinical trial (15ug/7.5ug) were 85% and 77%, respectively, and the seroprotection rate was 92% for both. These figures exceed the approval criteria for influenza vaccines established by the U.S. Food and Drug Administration (FDA) in 2007.
The research team plans to continue follow-up observations up to 180 days to evaluate the long-term safety of the patch. They will also assess the durability of the immune response for each vaccine dose and the breadth of the influenza A H1 antigen response in subgroups of samples.
Michael Schrader, CEO of Vaxxas, said, "Only half of American adults receive the seasonal flu vaccine," adding, "This positive initial data combining GC Green Cross's safe and effective influenza vaccine with the MIMIX patch can overcome barriers such as needle phobia and injection site pain, positively impacting patients' lives."
MIMIX-Flu features microneedles attached to the patch that allow the vaccine drug to be slowly released, enabling appropriate control of the drug delivery speed and time. It can be shipped without requiring separate refrigerated distribution and causes minimal pain.
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