#AAN2022 – ND0612 Shows Good Safety Profile After 4+ Years

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by Marisa Wexler |

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ND0612, an investigational formulation of carbidopa/levodopa delivered continuously via a subcutaneous pump, was generally well-tolerated for more than four years of treatment in a Phase 2 clinical trial of Parkinson’s patients, new data show.

Findings reveal that the vast majority of adverse events (side effects) reported in people treated with ND0612 were reactions at the infusion site, which were “generally reversible and manageable,” researchers reported.

The data were presented at the American Academy of Neurology Annual Meeting, held April 2–7 in Seattle, Washington, in the poster, “Long-term safety of continuous levodopa/carbidopa infusion with ND0612: Results from the ongoing BeyoND study.”

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Parkinson’s disease is caused by the death and dysfunction of cells in the brain that are responsible for making dopamine, an important chemical messenger known as a neurotransmitter. Carbidopa/levodopa (CD/LD) is a mainstay of Parkinson’s treatment that basically works to give the brain extra raw materials with which to make dopamine.

Currently available CD/LD therapies are taken orally. By contrast, ND0612 is administered via a subcutaneous (under-the-skin) infusion using a specially designed pump, similar to those used to administer insulin to some people with diabetes.

The Phase 2 clinical trial BeyoND (NCT02726386) enrolled 214 with advanced Parkinson’s, all of whom were treated with ND0612. The original study lasted for a year, after which 114 people entered into an extension study that is continuing to evaluate long-term safety and efficacy outcomes.

As of May 2021, 64 participants remained in the study, with a treatment duration of up to 4.6 years.

Over the course of the entire study, 73% of participants reported at least one adverse event. The vast majority — 486 of 640 total events reported — were infusion reactions, such as nodules (atypical tissue growth), pain, bad bruising (hematoma), or dead, scab-like skin (eschar).

The only treatment-related systemic adverse event that affected more than 5% of patients was nausea, reported in 7% of participants.

During the entire study, the main reasons for discontinuing treatment were infusion reactions (17.7%), followed by lack of efficacy (14.5%) and other adverse events (12.1%). Among patients who discontinued treatment after finishing the original one-year BeyoND study, 17.5% discontinued due to adverse events, including four (3.5%) who withdrew due to infusion site reactions.

“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,” Stuart Isaacson, MD, co-author of the poster and professor at Florida International University, said in a press release.

“At this time, ND0612 is the only investigational subcutaneous, continuous levodopa/carbidopa treatment with safety data extending beyond one year,” Isaacson added.

The BeyoND trial is ongoing; some participants now have entered their sixth year of treatment.

BeyoND was sponsored by NeuroDerm, which is a subsidiary of Mitsubishi Tanabe Pharma Corporation.  NeuroDerm is currently running a Phase 3 clinical trial called BouNDless (NCT04006210), which is comparing ND0612 against standard oral immediate-release CD/LD therapy in Parkinson’s patients whose symptoms are not well-controlled with standard therapy.

The BouNDless study is recruiting participants at more than 100 locations in the U.S., Europe, and Israel.

Data from a previous month-long open-label study (NCT02577523) indicated that treatment with ND0612 rapidly improved clinical status as well as life quality.

“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,” said Laurence Salin, senior medical director of NeuroDerm.

Note: The Parkinson’s News Today team is providing coverage of the American Academy of Neurology (AAN) 2022 Annual Meeting. Go here to see the latest stories from the conference.