Zosano (ZSAN) Announces Publication of Clinical Data Demonstrating Comparable Immunogenicity of Trivalent Influenza Vaccine Formulated on its Transdermal Microneedle System Versus an Intramuscular Inj

Zosano Pharma Corporation (NASDAQ: ZSAN), a clinical-stage biopharmaceutical company, today announced the publication of Phase 1 clinical trial data in an article titled, “Immunogenicity and Safety of Inactivated Influenza Split-Virion Vaccine Administered via a Transdermal Microneedle System” in the Journal of Vaccines and Immunology. The data demonstrated that a low dose of a trivalent influenza vaccine administered via its transdermal microneedle system produced antibody levels that met EMEA’s three guidelines for influenza vaccine efficacy and was generally well tolerated.

“We are excited to report these results, which show that a lower dose of an influenza vaccine administered using our transdermal microneedle system produced antibody levels similar to an intramuscular injection of the same vaccine at a higher dose,” said Mahmoud Ameri, Ph.D., vice president of research and development at Zosano. “Notably, a number of diverse immune cells are present in the skin, and therefore, we believe administration of a vaccine via the outer layers of dermis has the potential to result in an enhanced immune response.”

Dr. Ameri continued, “Additionally, there are several disadvantages of intramuscular or subcutaneous injections, including the necessity for medical personnel to administer the vaccines, pain, and the risk of needlestick injury which is estimated to cost $535 million per year globally to treat. With our transdermal microneedle system, we have the potential to reduce these burdens, as well as improve patient compliance. These data further support the broad potential of our transdermal microneedle system and highlight the need to modernize the drug delivery technologies currently being used.”

The single-center, randomized Phase 1 study enrolled 90 subjects between the ages of 18 to 40 years to receive a trivalent influenza vaccine containing strains A/H1N1, A/H3N2, and B. Volunteers were randomized to receive the vaccine either via a transdermal microneedle system patch (10 g) worn for 5 minutes, the same patch worn for 15 minutes, or by intramuscular injection (15 g). Antibody levels were measured at Day 21 and compared to EMEA guidelines to assess immunogenicity of the treatment groups. All three EMEA criteria, including seroconversion rate, mean increase in hemagglutinin inhibition titer, and percentage of seroprotected subjects, were met for all three influenza strains in all treatment groups. Additionally, on day 21, most study participants considered microneedle patch application and removal to be less painful than intramuscular injection, and most considered the patch to be their first choice for mode of administration. The transdermal microneedle patch was generally well tolerated.

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