1708-P: Development of a Needle-Free, Self-Applied Microarray Patch for GLP-1 Delivery

Introduction and Objective: While glucagon-like peptide 1 (GLP-1) therapies are effective treatments for metabolic disease, poor adherence linked to perceived treatment complexity and access remains a problem. We are developing a needle-free, shelf-stable, self-applied, microarray patch (MIMIXTM MAP) as a new mode of delivery to address these barriers. Here, we compare the bioavailability of MIMIX MAP (intradermal) to subcutaneous (SQ) delivered semaglutide (Sema) in the Gottingen minipig model. Methods: Two MIMIX MAP array sizes (M1 and M2), each delivering a nominal Sema dose of 2nmol/kg, were compared to a dose-matched, SQ Sema control. Ten 12-month-old, male Gottingen minipigs (20-25 kg) were randomized 4:3:3 to receive Sema delivered by M1, M2 or SQ injection to the lower thorax. Plasma samples were collected at 15 timepoints through 168 hr post dose, processed and Sema quantified by LC/MS. Results were analyzed by noncompartmental pharmacokinetics. Results: Circulating Sema was quantifiable until the final 168 hr time point. Absorption was comparable between the two MAP groups and both modestly faster than SQ within the first 12 hours. The post-absorption phase (24 to 168 hours) was highly similar for all treatment groups. Each treatment group showed a similar Tmax (10-13 hr). MAP groups showed a modestly higher Cmax relative to SQ delivery. Mean AUCLAST were also comparable across all groups, with the largest gap noted between MAP groups at 10% (7230 vs. 6580 hr*ng/mL). The half-life (T1/2) was 84.5h, 86.5h and 86.3 h for M1, M2 and SQ respectively and was considered highly similar among treatment groups with comparable curve fitting quality (Rsq). Conclusion: In a clinically relevant model, using a clinically relevant dose, bioavailability is comparable for MIMIX MAP and SQ delivery of Sema. The MIMIX MAP is a promising alternative mode of delivery with the potential to address treatment hesitancy and adherence. Disclosure L. Tussey: Research Support; Novo Nordisk. Funding Study funded in part by NIDDK (1R43DK142429-01)