- Long-term safety data from the phase 2b BeyoND study demonstrates a positive ND0612 safety and tolerability profile beyond one year in people with Parkinson’s disease.
- 95% of study participants who completed one year of treatment enrolled in the extension period, with some patients continuing in their sixth year of treatment.
- The pivotal Phase 3 BouNDless study is ongoing; more data is being generated.
NeuroDerm Ltd., a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation, announced positive, long-term safety and tolerability data for ND0612 at the American Academy of Neurology Annual Meeting (in Seattle, April 2-7, and virtually, April 24-27). This investigational drug-device combination product provides minimally invasive, continuous subcutaneous infusion of liquid levodopa/carbidopa for people with Parkinson’s disease (PD) experiencing motor fluctuations.
Cumulative safety data from the ongoing BeyoND study for ND0612 was evaluated for the 114 participants enrolled in the long-term extension period of the study (beyond one year), with some participants having entered their sixth year of treatment. The analysis demonstrates that ND0612 treatment remains safe and well tolerated over the long term in people with Parkinson’s disease experiencing motor fluctuations.1
“At this time, ND0612 is the only investigational subcutaneous, continuous levodopa/carbidopa treatment with safety data extending beyond one year,” said Stuart Isaacson, MD, author of the BeyoND study long-term safety poster and Associate Professor of Neurology, FIU and Director, Parkinson’s Disease and Movement Disorders Center of Boca Raton, Fla. “This latest data reinforces a positive long-term safety and tolerability profile of ND0612, indicating it has the potential to become a convenient and safe treatment option for those struggling with motor fluctuations in Parkinson’s disease.”
Long-term safety analysis of ND0612 infusion beyond one year showed treatment-emergent adverse events (TEAEs) were generally mild to moderate.1 Over more than four years, only 17.5% of participants discontinued the study due to an adverse event after their first year of treatment, including four (3.5%) participants who withdrew due to infusion site reactions.1 Infusion site reactions were the most frequent TEAEs, such as nodules, hematoma, infection, pain, and eschar.1 Nausea was the only drug-related systemic TEAE with incidence over 5% (7.0%).
“Motor fluctuations can greatly impact the quality of life of those living with Parkinson’s disease, often driving patients to seek treatment beyond oral medications,” said Dr. Laurence Salin, Senior Medical Director of NeuroDerm. “For people with Parkinson’s disease not adequately controlled by oral levodopa/carbidopa, we hope ND0612 can potentially offer a more reliable, sustained relief of motor fluctuations.”
ND0612 provides minimally invasive, continuous subcutaneous infusion of liquid levodopa/carbidopa and is expected to be an innovative approach to unmet medical needs for people with Parkinson’s disease experiencing motor fluctuations. NeuroDerm and Mitsubishi Tanabe Pharma Group are continuing to work toward bringing new treatment options to patients with Parkinson’s disease.