Israeli subcutaneous delivery company NeuroDerm is forging ahead with its Parkinson's patch, enrolling patients in its second Phase II clinical trial of its patch pump designed to treat the disease with steady concentrations of the tried-and-true drug levodopa.
The mid-stage study is designed to enroll 30 Parkinson's patients to wear the patch, called ND0612, for 21 days, testing for safety, tolerability, drug levels in the blood and exploratory clinical parameters, according to a company statement. To support the study, the Michael J. Fox Foundation for Parkinson's Research committed a $1 million grant to NeuroDerm, its second such contribution.
Levodopa, used along with carbidopa for bioavailability, is a drug that helps settle the physical symptoms of Parkinson's, including tremors, stiffness and slowness of movement. It does this by converting to dopamine in the brain, which causes many of these symptoms. With a patch pump, NeuroDerm is looking to achieve a steady state of levodopa in plasma levels in the blood that will provide a more consistent treatment. According to NeuroDerm, this is the "holy grail of Parkinson's disease levodopa therapy."
The patch itself uses passive, chemical diffusion of a drug as opposed to other means such as mechanical or electrical delivery. This offers a more consistent dose than the traditionally oral delivery of levodopa, if it proves successful in the upcoming trials.
"An important objective of this study will be to assess longer term steady state levodopa concentrations in patients and obtain a first impression of their effect on the patients," NeuroDerm CEO Oded Lieberman said in a statement. "ND0612 bypasses the gastrointestinal tract, should not be influenced by intestinal absorption or oral ingestion of food or drugs, and is administered in a controlled, predetermined rate both day and night--a treatment mode that has not been available to date to Parkinson's patients. This trial marks an important step in the development of ND0612 that could become a breakthrough treatment option for Parkinson's disease patients."
NeuroDerm picked up $15 million in a finance round in 2012, and the year before that announced promising Phase II results of its earlier iteration of the patch, ND0611.
- here's the release