Radius Health, Inc. announced positive results from a Phase 1b clinical study to evaluate the transdermal BA058 Microneedle Patch. BA058 is the company’s novel anabolic (bone-building) drug for the treatment of osteoporosis currently also undergoing Phase 3 evaluation as a daily subcutaneous injection. The BA058 Microneedle Patch is Radius’ short wear-time, transdermal form of BA058 based on 3M Drug Delivery Systems’ Solid Microstructured Transdermal Systems (sMTS) microneedle technology platform. The successful trial demonstrated the ability of the BA058 Microneedle Patch to safely and rapidly deliver BA058 over a short wear time, with no increased exposure resulting from longer wear, as well as supportive biochemical evidence of bone-building activity following seven days of dosing.
The Phase 1b trial was a randomized, double-blind, placebo-controlled study designed to assess the pharmacokinetic (PK) profile, safety, and tolerability of single and multiple doses of BA058 delivered transdermally via microneedle patch. The trial also evaluated wear time and administration site tolerability compared to BA058 subcutaneous injection. The study was conducted on 74 otherwise healthy postmenopausal women from 50 to 80 years of age who received at least one daily dose of the BA058 Microneedle Patch, placebo, or BA058 Injection. The BA058 Microneedle Patch was shown to be safe and well-tolerated in all doses studied, consistent with results from Phase 1 and 2 studies of the company’s BA058 Injection product, and demonstrated a suitable PK profile relative to BA058 Injection.
Key findings from the trial include:
• Rapid release of BA058 from the microneedle patch
• Peak transdermal drug levels consistent with BA058 subcutaneous injection
• Faster time to reach peak concentration as well as more rapid elimination in plasma compared to subcutaneous injection
• Increase in the bone-formation marker P1NP in serum after seven days of exposure, consistent with bone-building activity
• Identification of optimal wear time of 5 minutes or less as well as effective sites of application
“These Phase 1 transdermal data provide further evidence of BA058’s potential to become an important new therapy for osteoporosis that rapidly and safely restores lost bone,” said Michael S. Wyzga, President and CEO of Radius. “With valuable data on wear time, application site, and the ability to quickly reach therapeutic plasma concentrations from transdermal application of BA058 now obtained, we look forward to launching a Phase 2 study in 2012 to evaluate the effects of the BA058 Microneedle Patch on bone mineral density.”
Date: December 21, 2011
Source: Radius Health, Inc.