DND Pharmatech Completes Patient Recruitment for Phase 2 Clinical Trial of Parkinson's Disease Treatment Candidate in the US

by Lee Gwanju

Published 18 Apr.2022 10:26(KST)

DND Pharmatech Completes Patient Recruitment for Phase 2 Clinical Trial of Parkinson's Disease Treatment Candidate in the US

[Asia Economy Reporter Lee Gwan-joo] DnD Pharmatech announced on the 18th that its U.S. subsidiary Neuraly has completed patient recruitment for the Phase 2 clinical trial of the Parkinson's disease treatment candidate 'NLY01' in the United States.

As of the end of last month, dosing was completed for 131 patients, and dosing is ongoing for 118 patients. The company explained that they recruited a total of 255 early-stage Parkinson's disease patients, exceeding the target recruitment of 240 patients.

NLY01 is a glucagon-like peptide-1 receptor (GLP-1R) agonist that selectively blocks the overactivation process of astrocytes by inhibiting the activation of microglia, which is the root cause of neuroinflammatory responses, thereby preventing the secretion of neurotoxic substances. Through this mechanism, it protects brain neurons and blocks neuroinflammatory responses, showing potential as the first disease-modifying treatment for Parkinson's disease.

This Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study conducted at more than 60 clinical trial sites across the United States and Canada. It involves a total of 255 patients with early Parkinson's disease who receive low-dose, high-dose, or placebo treatments. So far, patient dosing has proceeded smoothly without any notable side effects or safety issues, and the company expects to confirm the topline results around July next year.

CEO Seul-gi Lee stated, “Official patient registration is expected to be completed within April, and considering the 36-week dosing period, all dosing is expected to be completed by January next year.” She added, “As clinical trials to confirm efficacy are in full swing, we will do our utmost to provide a new drug that can fundamentally treat degenerative brain diseases as soon as possible.”

Meanwhile, DnD Pharmatech received IND (Investigational New Drug) approval for a Phase 2b clinical trial for Alzheimer's dementia from the U.S. Food and Drug Administration (FDA) in 2020, and plans to conduct a large-scale clinical trial this year involving 518 early Alzheimer's dementia patients in North America and Europe.