Long-Term Safety Profile from Phase 2b Clinical Trials of Parkinson's 합법적인 스포츠 웹사이트 Drug Candidate (ND0612) Presents at 2022 American Academy of Neurology Annual Meeting
April 4, 2022
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative Director: Hiroaki Ueno; hereinafter, “MTPC”), a member of the Mitsubishi Chemical Holdings Group, announced today that the positive long trials (BeyoND stutdy; hereinafter, “this study”)of the Parkinson's 합법적인 스포츠 웹사이트 drug candidate (ND0612) which is being conducted by its wholly owned subsidiary, NeuroDerm Ltd. (Head Office: Rehovot, Israel; CEO: Ayelet 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 합법적인 스포츠 웹사이트 experiencing motor fluctuations will be presented in AAN. 95% of participants who completed one patients continuing in their sixth year of treatment) and this is the first time that safety data beyond one year have been obtained from continuous levodopa/carbidopa treatment. Treatment-emergent adverse events (TEAEs) were generally mild to 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 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 합법적인 스포츠 웹사이트 to improve their quality of life as most of them experience motor fluctuations and difficult to adequately control it by oral medications along with the progress of the 합법적인 스포츠 웹사이트. a subcutaneous delivery system continuous infusion of liquid levodopa/carbidopa, is a therapeutic agent candidate for Parkinson's 합법적인 스포츠 웹사이트 that can potentially offer a more reliable, sustained relief of motor fluctuations. This study confirms that ND06 needs of Parkinson's 합법적인 스포츠 웹사이트 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 합법적인 스포츠 웹사이트 area and further continuing to create
*1 Dry and hard dead tissue
■About Parkinson’s 합법적인 스포츠 웹사이트
Parkinson’s 합법적인 스포츠 웹사이트 affects more than five million patients worldwide.1It is caused by decreasing dopamine signaling in the brain as dopaminergic brain cells die off.2Levodopa is the “Gold Standard” therapy for Parkinson’s 합법적인 스포츠 웹사이트 and nearly all patients receive it, together with a levodopa degradation inhibitor (usually carbidopa).3When administered orally, levodopa plasma concentrations undergo sharp fluctuations reaching high peaks and low troughs that contribute to the clinical and motor complications in patients with Parkinson’s 합법적인 스포츠 웹사이트.4With 합법적인 스포츠 웹사이트 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.4
■About 합법적인 스포츠 웹사이트
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 motor fluctuations in Parkinson's 합법적인 스포츠 웹사이트 patients by improving stable, therapeutic levodopa plasma concentrations.
■About NeuroDerm, Ltd.
NeuroDerm, Ltd. is a pharmaceutical company based in Israel with significant capabilities in new formulation research and technology development for combining pharmaceuticals with medical devices for the treatment of central nervous system 합법적인 스포츠 웹사이트s. MTPC w 2017 to expand its pipeline in the key R&D 합법적인 스포츠 웹사이트 area, central nervous system.https://neuroderm.com/
References
1. Global, regional, and national burden of Parkinson’s 합법적인 스포츠 웹사이트, 1990-2016: a systematic analysis for the Global Burden of 합법적인 스포츠 웹사이트 Study 2016. GBD 2016 Parkinson’s 합법적인 스포츠 웹사이트 Collaborators. Lancet Neurol; 939-953.
2. 합법적인 스포츠 웹사이트’s 101. The Michael J. Fox Foundation. Available at: https://www.michaeljfox.org/합법적인 스포츠 웹사이트s-101#q2. Accessed March 15, 2022.
3. S Fahn. Levodopa in the treatment of Parkinson’s 합법적인 스포츠 웹사이트. J Neural Transm Suppl.2006;(71):1-15. doi: 10.1007/978-3-211-33328-0_1.
4. C D Marsden. Problems with long-term levodopa therapy for Parkinson’s 합법적인 스포츠 웹사이트. Clin 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 합법적인 스포츠 웹사이트 experiencing motor fluctuations will be presented in AAN. 95% of participants who completed one patients continuing in their sixth year of treatment) and this is the first time that safety data beyond one year have been obtained from continuous levodopa/carbidopa treatment. Treatment-emergent adverse events (TEAEs) were generally mild to 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 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 합법적인 스포츠 웹사이트 to improve their quality of life as most of them experience motor fluctuations and difficult to adequately control it by oral medications along with the progress of the 합법적인 스포츠 웹사이트. a subcutaneous delivery system continuous infusion of liquid levodopa/carbidopa, is a therapeutic agent candidate for Parkinson's 합법적인 스포츠 웹사이트 that can potentially offer a more reliable, sustained relief of motor fluctuations. This study confirms that ND06 needs of Parkinson's 합법적인 스포츠 웹사이트 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 합법적인 스포츠 웹사이트 area and further continuing to create
*1 Dry and hard dead tissue
■About Parkinson’s 합법적인 스포츠 웹사이트
Parkinson’s 합법적인 스포츠 웹사이트 affects more than five million patients worldwide.1It is caused by decreasing dopamine signaling in the brain as dopaminergic brain cells die off.2Levodopa is the “Gold Standard” therapy for Parkinson’s 합법적인 스포츠 웹사이트 and nearly all patients receive it, together with a levodopa degradation inhibitor (usually carbidopa).3When administered orally, levodopa plasma concentrations undergo sharp fluctuations reaching high peaks and low troughs that contribute to the clinical and motor complications in patients with Parkinson’s 합법적인 스포츠 웹사이트.4With 합법적인 스포츠 웹사이트 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.4
■About 합법적인 스포츠 웹사이트
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 motor fluctuations in Parkinson's 합법적인 스포츠 웹사이트 patients by improving stable, therapeutic levodopa plasma concentrations.
■About NeuroDerm, Ltd.
NeuroDerm, Ltd. is a pharmaceutical company based in Israel with significant capabilities in new formulation research and technology development for combining pharmaceuticals with medical devices for the treatment of central nervous system 합법적인 스포츠 웹사이트s. MTPC w 2017 to expand its pipeline in the key R&D 합법적인 스포츠 웹사이트 area, central nervous system.https://neuroderm.com/
References
1. Global, regional, and national burden of Parkinson’s 합법적인 스포츠 웹사이트, 1990-2016: a systematic analysis for the Global Burden of 합법적인 스포츠 웹사이트 Study 2016. GBD 2016 Parkinson’s 합법적인 스포츠 웹사이트 Collaborators. Lancet Neurol; 939-953.
2. 합법적인 스포츠 웹사이트’s 101. The Michael J. Fox Foundation. Available at: https://www.michaeljfox.org/합법적인 스포츠 웹사이트s-101#q2. Accessed March 15, 2022.
3. S Fahn. Levodopa in the treatment of Parkinson’s 합법적인 스포츠 웹사이트. J Neural Transm Suppl.2006;(71):1-15. doi: 10.1007/978-3-211-33328-0_1.
4. C D Marsden. Problems with long-term levodopa therapy for Parkinson’s 합법적인 스포츠 웹사이트. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44.
