NeuroDerm, Ltd. announced today the results of a Phase I/II safety and pharmacokinetic trial of ND0611, administered as an adjunct therapy to Sinemet®, Sinemet® CR or Stalevo®, in patients with advanced Parkinson's disease. ND0611 is a proprietary carbidopa liquid formula administered sub-cutaneously via a dermal patch to increase the bioavailability and efficacy of orally- administered levodopa. Results of this study support the continued development of ND0611 for the treatment of Parkinson's disease.
This double-blind, randomized, six-way crossover study met all of its primary and secondary endpoints. The analysis showed that ND0611, when compared with placebo, showed meaningful, highly statistically significant improvement in all of the pharmacokinetic (PK) endpoints when administered with three most common oral levodopa therapies (immediate-release Sinemet®, Sinemet®-CR, and Stalevo®). The primary and secondary PK endpoints included levodopa half-life, the duration of levodopa concentration in excess of a threshold of 1000ng/ml in plasma, the area-under-the-concentration-time-curve and levodopa trough levels. The full results of this study will be presented at a future scientific meeting.
The most common adverse events across all treatment arms, including placebo, were vertigo, nausea, asthenia, back pain, myalgia, pain in extremity, headache and erythema. There were no clinically relevant effects seen in laboratory measured or vital signs.
"This first trial in patients of ND0611 hit all of its endpoints and was a complete success. ND0611 is an innovative treatment for PD and this important milestone justifies ND0611's further clinical and regulatory development," said Sheila Oren, MD, VP Clinical and Regulatory Affairs at NeuroDerm.
"One of our priorities at MJFF is to drive research that could improve the quality of life for people living with PD today," said Brian Fiske, PhD, director of research programs at MJFF. "NeuroDerm is working to develop a therapy that might do just that. By providing a more even and continuous supply of levodopa to the brain, ND0611 has the potential to limit the motor fluctuations that many patients experience during periods when their medication wears off."
"ND0611's remarkable success in its first phase I/II trial significantly raises the probability of it becoming a new treatment option for PD patients. ND0611 is unique: it is the first drug developed to administer carbidopa systemically; it acts directly on levodopa metabolism not only in the gastrointestinal tract; and it probably employs a different mode of action than orally administered carbidopa," said Oded S. Lieberman, PhD, NeuroDerm's Chairman and CEO. "ND0611 has now been shown to improve levodopa's bioavailability in patients with any type of oral levodopa drug used even improving the bioavailability of what is considered to be the best current levodopa oral therapy. One can now realistically hope that ND0611 may eventually establish a higher standard of care for PD patients undergoing oral LD therapy".
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