1791-P: Codelivery without Coformulation of Amylin Analog and GLP-1RA via a Shelf-Stable, Self-Applied Microarray Patch

Introduction and Objective: Amylin analogs are under development for the treatment of obesity due to their potential for better lean muscle mass preservation and improved tolerability compared with GLP-1 RAs. Codelivery with GLP-1 therapy has an additive benefit in weight loss compared with monotherapy but requires a complex and expensive dual-chamber injector due to API instability when coformulated. Here, we address the need for simplified delivery of combination therapies with a shelf-stable, self-applied, microarray patch (MAP) for the codelivery of amylin and GLP-1 without coformulation. Methods: Cagrilintide and cagrilintide + semaglutide microarray patches (MAPs) were manufactured using a machine vision guided printing system enabling spatial separation of APIs on the patch. Drug product and device quality attributes were evaluated, including API purity by RP-HPLC, API functional integrity by albumin binding ELISA, mechanical strength by Instron, and delivery efficiency by ex-vivo porcine skin MAP deployment. Cagrilintide MAPs and liquid drug substance (DS) were stored at up to 40C for 1 month to evaluate stability. Results: Cagrilintide MAPs were successfully manufactured, demonstrating comparable API purity and functional integrity to liquid DS control. In an accelerated stability study, cagrilintide MAPs retained API purity and device performance through at least 1 month at 40C, while a reduction in cagrilintide purity was observed in liquid after 1 month at 25C. Cagrilintide + semaglutide MAPs were then manufactured with APIs printed into separate needles on the array. Both APIs exhibited comparable purity and functional integrity to liquid DS. Combination MAP mechanical strength and delivery performance were comparable to monotherapy MAPs. Conclusion: The feasibility of codelivering amylin + GLP-1 combination therapy by MAP was demonstrated. By eliminating the need for coformulation and enabling shelf-stability, MAPs offer a patient-friendly alternative to complex and costly dual-chamber injectors. Disclosure K. Kosuda: Other - Employee, Board Member, and Stock/Shareholder; Current; Vaxess Technologies, Inc. A. Beliveau: Employee; Current; Vaxess Technologies. S. Gadhia: Employee; Current; Vaxess Technologies. J. Kluge: Employee; Current; Vaxess Technologies, Inc.