SBIR Phase I: Microneedle-Based Platform for Treatment of Autoimmune Skin Diseases

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of a new standard-of-care for managing autoimmune skin diseases through a microneedle-based platform that restores immune balance in the skin. This platform will improve patient outcomes by offering a safer alternative to current immunosuppressive standards and address the psychological and social impacts of autoimmune skin diseases. Also, the microneedle patch will empower patients by being both self-administered and discreet, offering a user-friendly solution that seamlessly integrates into daily life. Beginning with Alopecia Areata as its first indication and followed by conditions including vitiligo and psoriasis, this technology addresses a significant market niche, affecting up to 3-4% of the population. This Small Business Innovation Research (SBIR) Phase I project aims to advance a hydrogel-based microneedle patch for managing autoimmune skin diseases to achieve scale-up readiness. Traditional treatments for autoimmune skin diseases, like creams and ointments, lack efficacy due to their limited skin penetration. Microneedle-mediated therapies overcome this by effectively delivering therapeutics through the stratum corneum. However, consistent drug exposure between patients is a critical factor for regulatory approval. Reducing the administration time (or wear time) of the patch to minutes rather than hours can prevent premature patch detachment and minimize patient-to-patient variability in drug exposure. The project goals are to modulate the current drug release profile of the microneedles patch and determine the minimum wear time required for therapeutic efficacy. The Phase I strategy will be two-fold: (1) chemical iteration of the hydrogel matrix of the microneedle patch and (2) determining in an in vivo model of Alopecia Areata the impact of faster release kinetics on the therapeutic efficacy. This work is important since the final formulation will be ready for scale-up manufacturing. 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.