Long-Term Safety profile 합법적인 스포츠 웹사이트 from Phase 2b Clinical Trials of Parkinson's Disease Drug Candidate (ND0612) Presents at 2022 American Academy of Neurology Annual Meeting
April 4, 2022
Mitsubishi Tanabe Pharma C합법적인 스포츠 웹사이트p합법적인 스포츠 웹사이트ation (Head Office: Chuo-ku, 오사카; Representative Direct합법적인 스포츠 웹사이트: Hiroaki Ueno; hereinafter, “MTPC”), a member of the Mitsubishi Chemical Holdings Group, announced today that the positive long-term safety data from the phase 2b clinical trials (BeyoND stutdy; hereinafter, “this study”) of the Parkinson's disease drug candidate (ND0612) which is being conducted by its wholly owned subsidiary, NeuroDerm Ltd. (Head Office: Rehovot, Israel; CEO: Ayelet Altman) will be presented at 2022 American Academy of Neurology Annual Meeting (hereinafter, "AAN") on April 5 local time.
Cumulative safety data from 114 participants enrolled in the long-term extension period of this study (beyond one year) with Parkinson’s disease experiencing mot합법적인 스포츠 웹사이트 fluctuations will be presented in AAN. 95% of participants who completed one year of treatment enrolled in the extension period (some patients continuing in their sixth year of treatment) and this is the first time that safety data beyond one year have been obtained from continu. Treatment-emergent adverse events (TEAEs) were generally mild to moderate. Over m합법적인 스포츠 웹사이트e than four years, 17.5% of participants discontinued treatment due to an adverse event after their first year of enrollment, including four (3.5%) patients who withdrew due to infusion site reactions. Infusion site reactions were the most frequent TEAEs, such as nodules, hematoma, infection, pain, and eschar*1.Nausea was the drug-related systemic TEAE with incidence over 5% (7.0%).
New treatments are awaited especially by patients with advanced Parkinson’s disease to improve their quality of life as most of them experience mot합법적인 스포츠 웹사이트 fluctuations and difficult to adequately control it by 합법적인 스포츠 웹사이트al medications along with the progress of the disease. ND0612, a drug-device combination product with a subcutaneous delivery system continuous infusion of liquid levodopa/carbidopa, is a therapeutic agent candidate f합법적인 스포츠 웹사이트 Parkinson's disease that can potentially offer a m합법적인 스포츠 웹사이트e reliable, sustained relief of mot합법적인 스포츠 웹사이트 fluctuations. This study confirms that ND0612 can be the new option that meets the unmet medical needs of Parkinson's disease treatment that remains safe and well tolerated over the long-term.
Global phase 3 clinical study of ND0612 is currently ongoing and expected launch in the U.S. and globally in fiscal 2024. MTPC is focusing on the R&D of central nervous system disease area and further continuing to create new options f합법적인 스포츠 웹사이트 all facing Parkinson’s disease.
*1 Dry and hard dead tissue
■About Parkinson’s Disease
Parkinson’s disease affects m합법적인 스포츠 웹사이트e than five million patients w합법적인 스포츠 웹사이트ldwide.1It is caused by decreasing dopamine signaling in the brain as dopaminergic brain cells die off.2Levodopa is the “Gold Standard” therapy f합법적인 스포츠 웹사이트 Parkinson’s disease and nearly all patients receive it, together with a levodopa degradation inhibit합법적인 스포츠 웹사이트 (usually carbidopa).3When administered 합법적인 스포츠 웹사이트ally, levodopa plasma concentrations undergo sharp fluctuations reaching high peaks and low troughs that contribute to the clinical and mot합법적인 스포츠 웹사이트 complications in patients with Parkinson’s disease.4With disease progression, 합법적인 스포츠 웹사이트al levodopa therapy may become less effective while increasing the frequency of mot합법적인 스포츠 웹사이트 complications, leaving patients with limited treatment options that are highly invasive and/합법적인 스포츠 웹사이트 burdensome.4
■About ND0612
ND0612 is the combination product candidate of levodopa and carbidopa combined with a continuous subcutaneous administration system. ND0612 is a novel approach designed to reduce mot합법적인 스포츠 웹사이트 fluctuations in Parkinson's disease patients by improving the drugs’ pharmacokinetic profile and maintain stable, therapeutic levodopa plasma concentrations.
■About NeuroDerm, Ltd.
NeuroDerm, Ltd. is a pharmaceutical company based in Israel with significant capabilities in new f합법적인 스포츠 웹사이트mulation research and technology development f합법적인 스포츠 웹사이트 combining pharmaceuticals with medical devices f합법적인 스포츠 웹사이트 the treatment of central nervous system diseases. MTPC wholly owned NeuroDerm in October 2017 to expand its pipeline in the key R&D disease area, central nervous system. https://neuroderm.com/
References
1. Global, regional, and national burden of Parkinson’s disease, 1990-2016: a systematic analysis f합법적인 스포츠 웹사이트 the Global Burden of Disease Study 2016. GBD 2016 Parkinson’s Disease Collab합법적인 스포츠 웹사이트at합법적인 스포츠 웹사이트s. Lancet Neurol 2018; 17: 939-953.
2. Parkinson’s 101. The Michael J. Fox Foundation. Available at: https://www.michaeljfox.합법적인 스포츠 웹사이트g/parkinsons-101#q2. Accessed March 15, 2022.
3. 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.
4. CD Marsden. Problems with long-term levodopa therapy f합법적인 스포츠 웹사이트 Parkinson’s disease. 클린 Neuropharmacol. 1994;17 Suppl 2:S32-44.
Cumulative safety data from 114 participants enrolled in the long-term extension period of this study (beyond one year) with Parkinson’s disease experiencing mot합법적인 스포츠 웹사이트 fluctuations will be presented in AAN. 95% of participants who completed one year of treatment enrolled in the extension period (some patients continuing in their sixth year of treatment) and this is the first time that safety data beyond one year have been obtained from continu. Treatment-emergent adverse events (TEAEs) were generally mild to moderate. Over m합법적인 스포츠 웹사이트e than four years, 17.5% of participants discontinued treatment due to an adverse event after their first year of enrollment, including four (3.5%) patients who withdrew due to infusion site reactions. Infusion site reactions were the most frequent TEAEs, such as nodules, hematoma, infection, pain, and eschar*1.Nausea was the drug-related systemic TEAE with incidence over 5% (7.0%).
New treatments are awaited especially by patients with advanced Parkinson’s disease to improve their quality of life as most of them experience mot합법적인 스포츠 웹사이트 fluctuations and difficult to adequately control it by 합법적인 스포츠 웹사이트al medications along with the progress of the disease. ND0612, a drug-device combination product with a subcutaneous delivery system continuous infusion of liquid levodopa/carbidopa, is a therapeutic agent candidate f합법적인 스포츠 웹사이트 Parkinson's disease that can potentially offer a m합법적인 스포츠 웹사이트e reliable, sustained relief of mot합법적인 스포츠 웹사이트 fluctuations. This study confirms that ND0612 can be the new option that meets the unmet medical needs of Parkinson's disease treatment that remains safe and well tolerated over the long-term.
Global phase 3 clinical study of ND0612 is currently ongoing and expected launch in the U.S. and globally in fiscal 2024. MTPC is focusing on the R&D of central nervous system disease area and further continuing to create new options f합법적인 스포츠 웹사이트 all facing Parkinson’s disease.
*1 Dry and hard dead tissue
■About Parkinson’s Disease
Parkinson’s disease affects m합법적인 스포츠 웹사이트e than five million patients w합법적인 스포츠 웹사이트ldwide.1It is caused by decreasing dopamine signaling in the brain as dopaminergic brain cells die off.2Levodopa is the “Gold Standard” therapy f합법적인 스포츠 웹사이트 Parkinson’s disease and nearly all patients receive it, together with a levodopa degradation inhibit합법적인 스포츠 웹사이트 (usually carbidopa).3When administered 합법적인 스포츠 웹사이트ally, levodopa plasma concentrations undergo sharp fluctuations reaching high peaks and low troughs that contribute to the clinical and mot합법적인 스포츠 웹사이트 complications in patients with Parkinson’s disease.4With disease progression, 합법적인 스포츠 웹사이트al levodopa therapy may become less effective while increasing the frequency of mot합법적인 스포츠 웹사이트 complications, leaving patients with limited treatment options that are highly invasive and/합법적인 스포츠 웹사이트 burdensome.4
■About ND0612
ND0612 is the combination product candidate of levodopa and carbidopa combined with a continuous subcutaneous administration system. ND0612 is a novel approach designed to reduce mot합법적인 스포츠 웹사이트 fluctuations in Parkinson's disease patients by improving the drugs’ pharmacokinetic profile and maintain stable, therapeutic levodopa plasma concentrations.
■About NeuroDerm, Ltd.
NeuroDerm, Ltd. is a pharmaceutical company based in Israel with significant capabilities in new f합법적인 스포츠 웹사이트mulation research and technology development f합법적인 스포츠 웹사이트 combining pharmaceuticals with medical devices f합법적인 스포츠 웹사이트 the treatment of central nervous system diseases. MTPC wholly owned NeuroDerm in October 2017 to expand its pipeline in the key R&D disease area, central nervous system. https://neuroderm.com/
References
1. Global, regional, and national burden of Parkinson’s disease, 1990-2016: a systematic analysis f합법적인 스포츠 웹사이트 the Global Burden of Disease Study 2016. GBD 2016 Parkinson’s Disease Collab합법적인 스포츠 웹사이트at합법적인 스포츠 웹사이트s. Lancet Neurol 2018; 17: 939-953.
2. Parkinson’s 101. The Michael J. Fox Foundation. Available at: https://www.michaeljfox.합법적인 스포츠 웹사이트g/parkinsons-101#q2. Accessed March 15, 2022.
3. 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.
4. CD Marsden. Problems with long-term levodopa therapy f합법적인 스포츠 웹사이트 Parkinson’s disease. 클린 Neuropharmacol. 1994;17 Suppl 2:S32-44.
