We are proud to announce that Movement Disorders Journal published the one-year safety data of ND0612 from the global Phase 2b study (BeyoND) in people with Parkinson’s Disease (PD) experiencing motor fluctuations.
Additional results from the study were also presented at the Movement Disorders Society (MDS) Virtual Congress 2021, September 17-22. These data were honored as a Top Abstract for the MDS 2021 Conference, which is intended to give broader visibility to the best original industry-led research, and were presented by lead investigator, Professor Werner Poewe, MD, Professor of Neurology and Director of the Department of Neurology at Medical University Innsbruck, Austria.
ND0612 is an investigational subcutaneous (SC) delivery system providing minimally invasive, continuous infusion of liquid 720/90mg levodopa/carbidopa for people with PD experiencing motor fluctuations. By avoiding gastric involvement, ND0612 provides increased bioavailability and reduced variability of LD/CD plasma levels in a convenient self-use manner. It is intended to replace current treatments for people with PD experiencing motor fluctuations that require invasive surgery associated with serious side effects, potentially offering more reliable, sustained relief.
The new publication shares results of the safety and tolerability of ND0612 over the first 12 months of treatment in the BeyoND study, which is 1 of 2 pivotal studies evaluating the safety and efficacy for this novel treatment.
“Continuous delivery of levodopa via a non-invasive and well tolerated approach is a key unmet need in the treatment of people with PD experiencing motor complications,” said Professor Werner Poewe, MD, a lead investigator of the BeyoND study. “Subcutaneous infusions of levodopa have the potential for a significant breakthrough in this therapeutic arena. The 12-month outcomes of the BeyoND study provide the largest dataset concerning safety and efficacy of SC levodopa infusions in the longer term. The results are very encouraging, showing both acceptable safety and sustained efficacy of ND0612 offering new hopes for people with PD affected by motor fluctuations, that are refractory to conventional treatment.”
This open-label, long-term safety study enrolled 214 patients who were each assigned one of two regimens: 16-hour/day SC infusion and 24-hour/day SC infusion. Both groups received a daily dose of 720/90mg levodopa/carbidopa from ND0612.
Results showed that over the first 12 months of treatment, based on 136 patient-years of accumulated exposure, ND0612 in both regimens was found to be safe, with generally mild to moderate local treatment-emergent adverse events that were reversible and manageable. Due to the SC administration, most patients experienced infusion site reactions such as nodules, hematoma, and pain, which were mostly classified as mild to moderate and led to discontinuation in only 10.3% of the participants. Systemic safety over 12 months was aligned with what was expected and typical for people with PD treated with levodopa/ carbidopa.
The study is ongoing and has been extended to 102 months, with some patients having now entered their sixth consecutive year on treatment with ND0612.
Exploratory efficacy analyses showed an improvement of up to 2.6 hours of ON time without troublesome dyskinesia and a decrease of 2.5 hours of OFF time. These improvements were maintained over the 12-month study period. The full efficacy analyses for ND0612 will come from the actively enrolling Phase 3, double-blind, double-dummy BouNDless study.
“These exploratory results describe the potential efficacy of ND0612 for patients with PD suffering from motor fluctuations,” said Laurence Salin, MD, Senior Medical Director at NeuroDerm. “These long-term safety data mark a major milestone for NeuroDerm as the results from this study establish the foundation of the safety profile data required by Regulatory Agencies in the US, Canada and Europe.”
“The robust, long-term safety data of ND0612 is pivotal to our mission of developing ND0612 as an effective, safe and more convenient treatment option for people with Parkinson’s experiencing motor fluctuations,” said Ayelet Altman, NeuroDerm Chief Executive Officer. “We have patients in their 6th consecutive year with ND0612 which demonstrate the value of this new therapy option over the long term. We are committed to continuous innovation to reduce disease burden and improve the quality of life of people with Parkinson’s and their families.”