Jul 28 2015
MENLO PARK, California—Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced positive topline interim results from its Phase 2a study designed to determine the pharmacokinetics (PK), pharmacodynamics (PDsafety and tolerability of its MicroCor transdermal system for the rapid delivery of a treatment for osteoporosis. The product delivers human parathyroid hormone, or hPTH(1-34) (known as teriparatide), a peptide that has been clinically proven to stimulate formation of new bone and reduce the risk of fractures. Teriparatide is approved for the treatment of osteoporosis by the U.S. Food and Drug administration (FDA) as a daily injection. The MicroCor transdermal system uses a novel biodegradable microstructure technology capable of delivering a wide range of drugs as an alternative to daily injections.
The Phase 2a study was conducted as a two-part clinical trial:
Part A was designed to evaluate single dose PK and the safety and tolerability of MicroCor PTH in healthy post-menopausal women, compared to the only approved hPTH(1-34) therapy, Eli Lilly’s Forteo (teriparatide (rDNA origin) injection);