NeuroDerm received a green light from the European Medicines Agency (EMA) for the main design elements of the amended iNDiGO trial evaluating ND0612 as a treatment for Parkinson’s disease in patients on levodopa with motor fluctuations.
The letter NeuroDerm received from the EMA’s Scientific Advice Working Party accepts the main amendments suggested by the company regarding its Phase 3 iNDiGO efficacy and safety trial (NCT02782481), including study population and primary and secondary endpoints.
Any company can request scientific advice from the EMA at any point in a drug candidate’s development. The goal is to expedite the development and provide high-quality, effective, and safe medications for people in the European Union.
NeuroDerm’s request for EMA scientific advice was based on its need to reach an agreement on the content of the iNDiGO trial protocol for ND0612. The clinical trial is now being conducted to support the registration of ND0612 in the E.U. and to ensure that the development program supporting a marketing authorization application (MAA) is complete.
“The acceptance of the main design elements for the iNDiGO trial protocol provided in the Scientific Advice Letter reaffirms NeuroDerm’s regulatory development strategy and constitutes a significant step forward for the development of ND0612 in Europe and the associated MAA submission,” Oded S. Lieberman, PhD, the CEO of NeuroDerm, said in a press release.
“The guidance provided in the letter allows us to move forward toward our goal to submit regulatory applications for ND0612 in Europe by the end of 2018,” he said.
ND0612, a combination of levodopa and carbidopa (LD/CD), was evaluated in a Phase 2 trial (NCT02577523). In this study, the investigative drug was found to eliminate “off” time (periods during the day when symptoms recurred) in 42% of the patients. In addition, ND0612 reduced off time in the group as a whole from an average of 5.6 hours during the day before treatment to 2.8 hours after treatment.
NeuroDerm currently has three clinical stage product candidates in development for Parkinson’s disease. The primary product candidates are a line of LD/CD products administered through small belt pumps.
The investigative treatments ND0612L and ND0612H are delivered subcutaneously. ND0701, a new subcutaneously delivered apomorphine formulation, is also being developed for Parkinson’s patients who don’t respond well to levodopa or carbidopa therapy.