BeyoND Phase 2b Data Indicates ND0612 Has a Positive Long-Term Safety Profile for People with Parkinson's Disease

NeuroDerm presents data at 2022 American Academy of Neurology Annual Meeting

• 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 disease¹
• 95% of study participants who completed one year of treatment enrolled in the extension period, with some patients continuing in their sixth year of treatment¹
• The pivotal Phase 3 BouNDless study is ongoing; more data is being generated

REHOVOT, Israel, April 4, 2022 /PRNewswire/ -- 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%).¹

"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.

About Parkinson's Disease
Parkinson's disease affects more than five million patients worldwide.² It is caused by decreasing dopamine signaling in the brain as dopaminergic brain cells die off.³ Levodopa is the "Gold Standard" therapy for Parkinson's disease and nearly all patients receive it, together with a levodopa degradation inhibitor (usually carbidopa).⁴ When administered orally, levodopa plasma concentrations undergo sharp fluctuations reaching high peaks and low troughs that contribute to the clinical and motor complications in people with Parkinson's disease.⁵ With disease progression, oral levodopa therapy may become less effective while increasing the frequency of motor complications, leaving patients with limited treatment options that are highly invasive and/or burdensome.⁵

About ND0612
ND0612 is an investigational drug-device combination product providing minimally invasive, continuous subcutaneous infusion of liquid levodopa/carbidopa for people with Parkinson's disease (PD) experiencing motor fluctuations. There is an ongoing unmet need for treatment innovation for people with Parkinson's disease, as oral levodopa/carbidopa treatments yield a variable and unfavorable pharmacokinetic profile. ND0612 is designed to improve the drugs' pharmacokinetic profile by avoiding gastric involvement and maintaining stable, therapeutic levodopa plasma concentrations.

About NeuroDerm, Ltd.
Based in Israel, NeuroDerm, Ltd. is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates that are designed to address major deficiencies of current treatments. NeuroDerm's technology enables new routes of administration for existing drugs to achieve clinical efficacy through continuous, controlled administration. NeuroDerm is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). For additional information, please visit NeuroDerm's corporate website at www.neuroderm.com.

About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Holdings Group (MCHC Group), founded in 1678, is one of the oldest pharmaceutical companies in the world and focuses on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. The MCHC Group has positioned healthcare as its strategic focus in its management policy, "Forging the future." MTPC sets the MISSION of "Creating hope for all facing illness" and prioritizing work on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, and focusing on the disease areas of central nervous system and immuno-inflammation. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/.

References

1. S Isaacson, C Warren Olanow, T Simuni, et al. Long-term safety of continuous levodopa/carbidopa infusion with ND0612: Results from the ongoing BeyoND study. Poster presented at: American Academy of Neurology Annual Meeting; 2022 Apr 2-7; Seattle, WA.
2. Global, regional, and national burden of Parkinson's disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. GBD 2016 Parkinson's Disease Collaborators. Lancet Neurol 2018; 17: 939-953.
3. Parkinson's 101. The Michael J. Fox Foundation. Available at: https://www.michaeljfox.org/parkinsons-101#q2. Accessed March 15, 2022.
4. S Fahn. Levodopa in the treatment of Parkinson's disease. J Neural Transm Suppl.2006;(71):1-15. doi: 10.1007/978-3-211-33328-0_1.
5. C D Marsden. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44.

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SOURCE NeuroDerm Ltd.