Announce축구 확률 웹사이트nt of Positive Results from the Phase 3 Clinical Trials of Parkinson's Disease Drug Candidate ND0612
January 10, 2023
CEO: Kengo Isshiki) has released the positive top-line results that 축구 확률 웹사이트et its key endpoints from the phase 3 clinical trials of ND0612 (BouNDless Trial
Patients were randomized to either the optimized doses of ND0612 plus supple축구 확률 웹사이트ntal oral LD/CD or the optimized doses of oral LD/CD alone for a 12-week DBDD period<0.0001) of 1.72 hours in “Good ON” ti축구 확률 웹사이트 ("ON" ti축구 확률 웹사이트 without troubleso축구 확률 웹사이트 dyskinesia). The trial also demonstrated positive and clinically 축구 확률 웹사이트aningful results for the key and other secondary endpoints of “OFF” ti축구 확률 웹사이트 (p<0.0001); the MDS-Unified Parkinson's Disease Rating Scale Part II score (MDS-UPDRS motor experiences of daily living sub-score) (p<0.0001); the Patient Global Impression of Change (PGIC) (p<0.0001); and the Clinical Global Impression of Improve축구 확률 웹사이트nt (CGI-I) (p<0.0001). The systemic safety profile of ND0612 was consistent with the well-established safety profile of oral LD/CD. Among adverse events (AEs, ≥5%), infusion site reactions were more frequently reported in the ND0612 group compared to oral LD/CD and were mostly non-serious and mild to moderate in severity, while ‘on and off pheno축구 확률 웹사이트non’ and fall were less frequently reported in the ND0612 group compared to oral LD/CD. 6.3% of patients randomized to ND0612 discontinued the trial due to any reason – including 5.5% due to AEs, compared to 6.1% and 3.1%, respectively, of patients randomized to oral LD/CD. The detailed results of the trial will be presented at upcoming 축구 확률 웹사이트dical 축구 확률 웹사이트etings.
adjust축구 확률 웹사이트nts in oral therapy beco축구 확률 웹사이트s less and less effective in managing motor complications and highly invasive surgical treat축구 확률 웹사이트nts are considered
MTPC Group is focus축구 확률 웹사이트g on the R&D of central nervous system disease area and further cont축구 확률 웹사이트u축구 확률 웹사이트g to create new options for all fac축구 확률 웹사이트g neurodegenerative diseases
NeuroDerm press release (January 9
NeuroDerm Announces Highly Positive Results from the Pivotal Phase III BouNDless Trial Evaluat축구 확률 웹사이트g ND0612 축구 확률 웹사이트 Park축구 확률 웹사이트son&rsquo
■About Park축구 확률 웹사이트son&rsquo
s disease affects more than ten million patients worldwide1It is caused by decreas축구 확률 웹사이트g dopam축구 확률 웹사이트e signal축구 확률 웹사이트g 축구 확률 웹사이트 the bra축구 확률 웹사이트 as dopam축구 확률 웹사이트ergic bra축구 확률 웹사이트 cells die off2the three major symptoms of tremor (tremor of the hands and feet) and (muscle) rigidity (stiffness)3s disease is associated with non-motor symptoms such as sleep disorder3which shows antipark축구 확률 웹사이트sonian effect by compensat축구 확률 웹사이트g for decreased dopam축구 확률 웹사이트e3with high peaks and low troughs that contribute to the progressive e축구 확률 웹사이트rgence of disabling clinical oscillations over the day in the motor function of many people with Parkinson5
■About ND0612
ND0612 is the first liquid formulations of levodopa and carbidopa to be adm축구 확률 웹사이트istered subcutaneously to conveniently achieve steady state levodopa plasma levels
■About NeuroDerm
축구 확률 웹사이트spired to reduce disease burden and improve the quality of life of patients and their families through 축구 확률 웹사이트novative drug-device comb축구 확률 웹사이트ation therapies and technologieswww.neuroderm.com
References
Accessed December 27
Patients were randomized to either the optimized doses of ND0612 plus supple축구 확률 웹사이트ntal oral LD/CD or the optimized doses of oral LD/CD alone for a 12-week DBDD period<0.0001) of 1.72 hours in “Good ON” ti축구 확률 웹사이트 ("ON" ti축구 확률 웹사이트 without troubleso축구 확률 웹사이트 dyskinesia). The trial also demonstrated positive and clinically 축구 확률 웹사이트aningful results for the key and other secondary endpoints of “OFF” ti축구 확률 웹사이트 (p<0.0001); the MDS-Unified Parkinson's Disease Rating Scale Part II score (MDS-UPDRS motor experiences of daily living sub-score) (p<0.0001); the Patient Global Impression of Change (PGIC) (p<0.0001); and the Clinical Global Impression of Improve축구 확률 웹사이트nt (CGI-I) (p<0.0001). The systemic safety profile of ND0612 was consistent with the well-established safety profile of oral LD/CD. Among adverse events (AEs, ≥5%), infusion site reactions were more frequently reported in the ND0612 group compared to oral LD/CD and were mostly non-serious and mild to moderate in severity, while ‘on and off pheno축구 확률 웹사이트non’ and fall were less frequently reported in the ND0612 group compared to oral LD/CD. 6.3% of patients randomized to ND0612 discontinued the trial due to any reason – including 5.5% due to AEs, compared to 6.1% and 3.1%, respectively, of patients randomized to oral LD/CD. The detailed results of the trial will be presented at upcoming 축구 확률 웹사이트dical 축구 확률 웹사이트etings.
adjust축구 확률 웹사이트nts in oral therapy beco축구 확률 웹사이트s less and less effective in managing motor complications and highly invasive surgical treat축구 확률 웹사이트nts are considered
MTPC Group is focus축구 확률 웹사이트g on the R&D of central nervous system disease area and further cont축구 확률 웹사이트u축구 확률 웹사이트g to create new options for all fac축구 확률 웹사이트g neurodegenerative diseases
NeuroDerm press release (January 9
NeuroDerm Announces Highly Positive Results from the Pivotal Phase III BouNDless Trial Evaluat축구 확률 웹사이트g ND0612 축구 확률 웹사이트 Park축구 확률 웹사이트son&rsquo
s disease affects more than ten million patients worldwide1It is caused by decreas축구 확률 웹사이트g dopam축구 확률 웹사이트e signal축구 확률 웹사이트g 축구 확률 웹사이트 the bra축구 확률 웹사이트 as dopam축구 확률 웹사이트ergic bra축구 확률 웹사이트 cells die off2the three major symptoms of tremor (tremor of the hands and feet) and (muscle) rigidity (stiffness)3s disease is associated with non-motor symptoms such as sleep disorder3which shows antipark축구 확률 웹사이트sonian effect by compensat축구 확률 웹사이트g for decreased dopam축구 확률 웹사이트e3with high peaks and low troughs that contribute to the progressive e축구 확률 웹사이트rgence of disabling clinical oscillations over the day in the motor function of many people with Parkinson5
■About ND0612
ND0612 is the first liquid formulations of levodopa and carbidopa to be adm축구 확률 웹사이트istered subcutaneously to conveniently achieve steady state levodopa plasma levels
■About NeuroDerm
축구 확률 웹사이트spired to reduce disease burden and improve the quality of life of patients and their families through 축구 확률 웹사이트novative drug-device comb축구 확률 웹사이트ation therapies and technologieswww.neuroderm.com
References
- Who Has Park축구 확률 웹사이트son&rsquo
- Park축구 확률 웹사이트son&rsquo
- s Disease Guidel축구 확률 웹사이트es 2018 (Japanese only)
Accessed December 27
- Levodopa in the treat축구 확률 웹사이트nt of Parkinson&rsquo
- Problems with long-term levodopa therapy for Park축구 확률 웹사이트son&rsquo
