2024-03-20 02:54:35
REHOVOT, Israel, March 20, 2024 /PRNewswire/ — NeuroDerm Ltd, a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), today announced the publication of results from the pivotal phase 3 trial BouNDless (NCT04006210) in The Lancet Neurology known.
Data published in The Lancet Neurology show favorable efficacy of ND0612 compared to immediate-release oral levodopa/carbidopa
The results of the study evaluating the efficacy, safety and tolerability of the investigational drug ND0612 – a continuous, 24 hour/day subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) – compared to immediate-release oral LD/CD ( IR) in Parkinson’s patients with motor fluctuations met the primary endpoint and the first four secondary endpoints and showed that ND0612 increased the “ON” time without bothersome dyskinesias compared to oral IR-LD/CD after 12 weeks and the “OFF” time reduced.
“Oral levodopa/carbidopa tablets remain the main pharmacological intervention in Parkinson’s disease. However, over time, the reliability of their benefit may decrease, leading to the occurrence of motor fluctuations,” said Professor Alberto Espay, lead US investigator of the BouNDless trial and director of the James J. and Joan A. Gardner Family Center for Parkinson’s Disease and Movement Disorders at the University of Cincinnati. “We are encouraged by these positive data, which we believe, if approved, will support ND0612 as a potential treatment option for people with Parkinson’s disease who experience motor fluctuations and for whom it has been previously available “There were only limited options available.”
Study participants participated in an open-label IR-LD/CD optimization phase, followed by an open-label ND0612 plus IR-LD/CD optimization phase, and were then randomly assigned to a 12-week double-blind, double-dummy treatment ( DBDD) with either ND0612 or oral IR-LD/CD therapies. Key findings from the study include:
Treatment with ND0612 demonstrated superior efficacy with a statistically significant increase (p<0.0001) in "ON" time of 1.72 hours without bothersome dyskinesias compared to oral IR-LD/CD, meeting the primary endpoint of the Study. The study also demonstrated statistically significant and clinically meaningful results for the first four secondary endpoints, including the key secondary endpoint of an additional 1.4 hour reduction in daily "OFF" time (p<0.0001) with ND0612 IM Comparison to oral IR-LD/CD. Additional secondary endpoints that achieved statistical significance and clinically relevant improvements for both patients and their physicians included Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II scores (-3.05 [-4,28, -1,81]p<0,0001), der Patients Global Impression of Change (Odds Ratio [OR]: 5,31 [2,67, 10,58]p<0,0001) und Clinician Global Impression of Improvement (OR: 7,23 [3,57, 14,64]p<0.0001). Das systemische Sicherheitsprofil von ND0612 entsprach dem gut etablierten Sicherheitsprofil der oralen Standardtherapie LD/CD. Wie erwartet, waren aufgrund der kontinuierlichen subkutanen Verabreichung Reaktionen an der Infusionsstelle (ISRs) die am häufigsten gemeldeten unerwünschten Ereignisse bei der Behandlung (57 % bei ND0612 gegenüber 43 % bei IR-LD/CD während des DBDD-Zeitraums der Studie). Die meisten ISRs waren von geringem Schweregrad. Bemerkenswert ist, dass Dyskinesien, Stürze und ON/OFF-Phänomene in der ND0612-Gruppe im Vergleich zur IR-LD/CD-Gruppe weniger häufig berichtet wurden. Außerdem brachen nur 6 % der Studienteilnehmer in der ND0612-Gruppe die Studie während des DBDD-Zeitraums aus irgendeinem Grund ab, verglichen mit 6 % in der oralen IR-LD/CD-Gruppe.
“Motor fluctuations are an all-too-common symptom associated with oral LD/CD use in Parkinson’s disease and often cause significant disruption in daily life as the disease progresses,” said Tami Yardeni, EVP, Clinical Development, NeuroDerm. ” We now have convincing evidence of the favorable benefit-risk profile of ND0612. These results demonstrate significant improvement in motor fluctuations as well as improvement in daily living experiences for this difficult patient population.”
Analyzes of results from the ongoing BouNDless trial complement long-term safety data from the BeyoND trial (NCT02726386), which includes patients in the eighth year of follow-up.1
Information about Parkinson’s disease
Parkinson’s disease affects more than 10 million people worldwide. It is caused by a decrease in dopamine signaling in the brain, causing dopaminergic brain cells to die. Levodopa is the main replacement therapy for Parkinson’s disease and is given together with a levodopa degradation inhibitor (usually carbidopa). Oral administration of levodopa results in fluctuating plasma concentrations with high peaks and low troughs, which contribute to the progressive development of disabling clinical fluctuations in motor function throughout the day in many Parkinson’s patients. As the disease progresses, adjustments to oral levodopa therapy become less effective in managing such motor complications, leaving patients with limited and highly invasive treatment options.
Information about ND0612
ND0612 is an investigational drug-device combination therapy – a 24-hour continuous subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) for the treatment of motor fluctuations in people with Parkinson’s disease (PD). The safety and efficacy of ND0612 in Parkinson’s disease is currently under review by the U.S. Food and Drug Administration (FDA), which has set a target date for approval under the Prescription Drug User Fee Act (PDUFA) for the second quarter of CY (calendar year). set for 2024.
Information about NeuroDerm, Ltd.
NeuroDerm, Ltd. is a wholly owned subsidiary of Israel-based Mitsubishi Tanabe Pharma Corporation (MTPC), committed to reducing the burden of disease and improving the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical device company developing central nervous system (CNS) product candidates that address key weaknesses in current treatments. For more information, please visit NeuroDerm’s website atwww.neuroderm.com or follow us on LinkedIn.
About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharmaceutical division of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678 and focused on ethical medicines. MTPC’s headquarters are located in Doshomachi, Osaka, the cradle of the Japanese pharmaceutical industry. The MCG has set health care as a strategic focus in its management policy “Forging the future”. MTPC has set the MISSION to “create hope for all who face illness”. To this end, the MTPC works on the disease areas of the central nervous system, immune inflammation, diabetes and kidneys, and cancer. MTPC focuses on “precision medicine” to provide medications with high treatment satisfaction by identifying patient groups with high efficacy and safety potential. In addition, MTPC is working to develop “round-the-pill” solutions to address specific patient concerns the basis of therapeutic medicine, including disease prevention, pre-symptomatic treatment of disease, prevention of exacerbations and prognosis. For more information, see https://www.mt-pharma.co.jp/e/.
Information about Mitsubishi Tanabe Pharma America, Inc.
Mitsubishi Tanabe Pharma America, Inc. (MTPA), based in Jersey City, NJ, is a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), which is wholly owned by the U.S. holding company Mitsubishi Tanabe Pharma Holdings America, Inc. located. It was founded by MTPC to market approved pharmaceutical products in North America. For more information please visit www.mt-pharma-america.com or follow us on Twitter, Facebook< /a> and LinkedI n.
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1S Isaacson, et al. Long-term safety of continuous levodopa/carbidopa infusion with ND0612: results from the ongoing BeyoND Study. Posters presented at: American Academy of Neurology Annual Meeting; 2022 Apr 2-7; Seattle, WA.
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