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Corium begins Phase I trial of Corplex Donepezil transdermal system to treat Alzheimer’s disease

Corium International (CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, announced the commencement of dosing in a Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of Corplex Donepezil Transdermal System for the sustained and controlled delivery of a treatment for Alzheimer's disease.

The product, which is based on Corium’s proprietary transdermal formulation and adhesive technology, is designed to deliver donepezil (the active ingredient in Aricept) for up to seven days in a single-patch application.

Donepezil, an anticholinesterase inhibitor, is a leading Alzheimer’s drug approved for the treatment of mild, moderate, and severe disease as a daily tablet.

"We believe there is a significant need for a multi-day transdermal donepezil product for patients diagnosed with Alzheimer’s disease, offering the potential to improve therapeutic compliance and convenience for patients and their caregivers," said Parminder "Bobby" Singh, Ph.D., Corium’s Chief Technology Officer and Vice President, Research and Development.

"Initiation of this Phase 1 pharmacokinetics clinical trial is a major milestone for Corium, and for the advancement of our Corplex technology platform in neurology product applications. We look forward to moving additional neurology candidates into the clinic in the coming months."

The Phase 1 study is a single-dose, crossover study of 12 subjects in the age group representative of Alzheimer’s disease (50-80 years of age). The primary objective of the study is to assess the pharmacokinetic profile of two Corplex Donepezil formulations over seven days, compared to the Aricept tablet.

The secondary objectives are assessment of safety and skin tolerability, and evaluation of pharmacodynamics by measuring changes in concentrations of a well-characterized biomarker. The trial, which is expected to be completed in late 2015, follows extensive preclinical evaluation in predictive human skin and animal models that demonstrated sustained delivery over a seven-day period.

Corium is also developing a second Alzheimer’s disease product candidate, a transdermal patch delivering memantine (the active ingredient in Namenda and Namenda XR), which is expected to enter Phase 1 clinical trials during the fourth calendar quarter of 2015.