NeuroDerm Ltd. , a clinical stage pharmaceutical Company developing drugs for central nervous system (CNS) disorders, announced the completion of a pilot study (trial 101) in healthy subjects comparing the pharmacokinetics (PK) of ND0701, the Company’s proprietary continuous, subcutaneously delivered apomorphine liquid formulation, and commercial apomorphine (APOGO®). Study results demonstrate that ND0701 produced PK results that were comparable to those produced by the referenced drug. Based on these results, the Company plans to pursue a PK similarity regulatory development route in the EU for ND0701, will initiate a follow-up comparison PK study in the first half of 2017 and meet with European regulatory authorities in the second half of 2017 to discuss its development strategy. The Company is evaluating in parallel the development of ND0701 for the U.S. market.
Trial 101 was a pilot crossover, randomized, two-sequence, 12-hour study with 18 healthy volunteers. The primary objective was to evaluate the PK and relative bioavailability of sub-cutaneous infusion of ND0701 and commercial apomorphine. No formal power analysis was performed for this study. Plasma PK measures of ND0701 were comparable to the reference drug. These results support the continuation of ND0701’s development path to demonstrate its therapeutic equivalence to the reference drug. ND0701 did not raise safety and tolerability concerns, and exhibited a slightly better safety profile than that of the reference drug.
“We are pleased that trial 101 yielded positive results,” said Oded S. Lieberman, PhD, CEO of NeuroDerm. “The PK profile of ND0701 supports its continued development as a potentially important new, continuous dopaminergic treatment alternative for advanced Parkinson’s patients, designed for eventual administration through a patch pump. Data from this pilot study will enable us to optimize the design of the upcoming study, and to proceed with a PK similarity regulatory development in the EU.”
ND0701 contains apomorphine, the most potent dopamine agonist. Apomorphine, administered subcutaneously, is the most effective drug for the symptomatic treatment of Parkinson's disease after levodopa. Apomorphine is approved both in the United States and in the EU for acute administration as rescue treatment for off periods in Parkinson's disease (currently administered subcutaneously as bolus injections) and only in the EU and not in the United States for continuous, subcutaneously delivered chronic therapy of advanced Parkinson's patients.
