Phase 1 clinical trial shows safety and immunogenicity of microneedle patch for flu vaccination for the first time

ATLANTA, June 28, 2017 -- Using microneedle patch technology under development at Micron Biomedical, Inc. (Micron), a Phase 1 clinical trial showed that vaccination by microneedle patch was as safe and at least as immunogenic as vaccination with standard needle and syringe. The trial was carried out by the Georgia Institute of Technology (Georgia Tech) and the Emory University Hope Clinic.  The results were published in the prestigious medical journal The Lancet (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30575-5/fulltext?elsca1=tlpr).

“We are very pleased with these results,” says Devin McAllister, PhD, Micron’s Vice President, R&D, and co-founder, “as they show the great potential of the painless, applicator-free microneedle patch technology platform that Micron is building upon to improve delivery of drugs and vaccines.”

The first-in-humans, Phase 1 clinical trial enrolled 100 subjects and investigated the safety, immunogenicity, and acceptability of a seasonal flu vaccine delivered either by microneedle patch or by standard hypodermic needle and syringe. The study also compared the ability of study participants to self-administer the microneedle patches.

The results showed that vaccination by microneedle patch was safe, well tolerated by study participants, and generated an immune response that was at least as strong as with the standard intramuscular injection. Moreover, subjects overwhelmingly (>70%) preferred the microneedle patch over the needle and syringe as their future vaccination method.  The study also showed that participants could self-administer the patch.

The microneedle patch technology used in the study was developed at Georgia Tech in the laboratory of Mark Prausnitz, PhD, Regents’ Professor of Chemical and Biomolecular Engineering and is now being licensed and developed for commercialization by Micron. Dr. Prausnitz co-founded Micron and serves as its Chief Scientific Officer. “The phase 1 clinical trial confirms that the microneedle patch technology is safe, immunogenic, easy to use, and preferred by people,” says Dr. Prausnitz, who adds that, “Micron is leveraging these excellent results to continue the pre-clinical and clinical development of its microneedle patch product portfolio.”

About Micron Biomedical

Micron is a biopharmaceutical company on a rapid path to commercialize its novel vaccine and drug delivery technology, based on dissolving microneedle patches, aimed at achieving better health outcomes through enhanced therapeutic effects, simplified logistics, and improved patient compliance.

Media Contact Information:
Sebastien Henry, MS, MBA
Vice President, Program Management
Tel: 770-722-0306
[email protected]
www.micronbiomedical.com