I-Corps: Translation potential of a microneedle bandage for treating Borrelia skin infections

University Of Connecticut, Storrs CT

Investigators

Abstract

The broader impact of this I-Corps project is the development of a doxycycline-loaded microneedle bandage that patients can apply over a tick bite to kill the Borrelia burgdorferi, the cause of Lyme Disease. This technology empowers consumers with an immediate and powerful preventative approach that will disrupt the current standard of care and move consumers and the healthcare community toward a proactive approach for treating tick bites. If widely adopted, this product could prevent approximately 200,000 cases of acute Lyme Disease and 20,000 cases of post-treatment Lyme Disease Syndrome per year in the United States alone. The current practice of treating tick bites either prophylactically or after the appearance of a bullseye rash with high oral doses of antibiotics has risks including drug allergy, intestinal dysbiosis, sun sensitivity, and dental issues that could be avoided with locally acting, low-dose microneedle bandages. Efficacy has been demonstrated in microneedle patches targeting other dermal bacterial infections, providing a solid rationale for this approach. As no product like this has been marketed to date, there is considerable opportunity for preventing Lyme Disease and potentially for other dermal infections prone to systemic dissemination. This I-Corps project utilizes experiential learning coupled with a first-hand investigation of the industry ecosystem to assess the translation potential of the technology. This solution is based on the development of a therapeutic bandage comprising of highly innovative biodegradable microneedles in conjunction with a novel bandage matrix. Several innovations make this possible. First, the microneedles penetrate the dermal tissue surrounding the tick bite for highly localized dermal drug delivery. Upon contact with interstitial fluid, the microneedle tips dissolve rapidly and delivers doxycycline. Secondly, the microneedle bases dissolve slowly, releasing a host-directed therapeutic agent which recruits and activates immune cells to kill any bacteria that survive the initial antibiotics. After the microneedle tips dissolve, a bidirectional microchannel is exposed, facilitating drainage. Four prototyping rounds have occurred, and testing has begun in two animal models, plus explanted (living) human skin. The structural integrity, dissolution characteristics, and doxycycline stability throughout the microneedle formulation and molding process have been assessed. Using two fluorescent dyes, the kinetics of drug release and neutrophil migration to the site of microneedle application in mice and pigs has been documented. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.