NeuroDerm Announces Positive Phase II Results of Dermal Patch for Patients with Parkinson's

NeuroDerm, Ltd. recently announced 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 subcutaneously 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 1000 ng/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,” added 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.”

This placebo controlled, randomized, double-blind, six-way crossover trial enrolled 24 patients with advanced Parkinson’s disease. All patients were administered the three most commonly-used levodopa therapies (previously mentioned) in 100-mg dosage four times per day; in addition they received either ND0611 or placebo.

In addition to evaluating safety and tolerability, the study’s primary endpoint was improvement in levodopa half-life in all treatment arms; secondary endpoints included additional PK parameters. All PK parameters for each oral treatment mode were evaluated separately and showed statistical significance. This trial was supported by a grant of $1 million by The Michael J. Fox Foundation for Parkinson’s Research as part of the Foundation’s Clinical Intervention Awards 2010 program.

NeuroDerm is an emerging pharmaceutical company that develops therapies for the treatment of CNS diseases. NeuroDerm’s technology is based on proprietary reformulations of well-established oral drugs whose low bioavailability is the major impediment to better efficacy.