Kris Hansen1, Daniel Dohmeier1, Tom Fenn1, Joan Moseman1, David Wirtanen1, Jim Christensen1, Simmon Schaefer1, Gary Hattersley2
13M Drug Delivery Systems; St. Paul, MN, 55144, USA; 2 Radius Health; Cambridge, MA, 02139, USA
Polymeric microneedle patches were coated with BA058, a novel analogue of hPTHrP (1-34), developed for the treatment of osteoporosis. The coated microneedles (solid Microstructured Transdermal System, sMTS) were characterized in-vivo and then utilized in a series of Phase 1 clinical trials designed to characterize product safety, tolerability and pharmacokinetics and to identify optimal wear time and application site. Over 500 applications of the coated microneedles were made in humans. The BA058 microneedle product demonstrated suitable safety and performance profiles and is proceeding through Phase II clinical evaluation.