DND Pharmatech Administers First Patient Dose in NLY01 Phase 2 Multiple Sclerosis Trial

DND Pharmatech announced that it has begun administering the first dose to a patient in the investigator-initiated Phase 2 clinical trial of pegsebrinatide (NLY01), a treatment for degenerative brain diseases, for progressive multiple sclerosis.

DND Pharmatech Company Logo Image. DND Pharmatech

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According to DND Pharmatech on May 6, this clinical trial is being led by Professor Ellen Mowry of the Multiple Sclerosis Center at Johns Hopkins University School of Medicine in the United States. It is being conducted as a multi-center study with the participation of major medical institutions, including the Icahn School of Medicine at Mount Sinai. The trial is named ‘TAG-MS’, and DND Pharmatech is supplying both the investigational drug and placebo required for the study.

The research team received approval for the Phase 2 clinical trial protocol from the U.S. Food and Drug Administration (FDA) in September 2024. The study is also supported by research funding from the International Progressive Multiple Sclerosis Alliance, a global multiple sclerosis consortium. This first patient dosing marks entry into the actual patient clinical trial phase.

The clinical trial will enroll 120 patients with progressive multiple sclerosis and will run for 96 weeks. The primary endpoint is the change in normalized brain parenchymal volume (nBPV) based on magnetic resonance imaging (MRI). Key secondary endpoints include changes in the Expanded Disability Status Scale (EDSS) and central nervous system biomarkers. The trial is designed as a randomized, double-blind study. Reflecting previous clinical results in Parkinson’s disease, the dosage is set at 10mg, with efficacy being primarily evaluated in patients under the age of 60.

Pegsebrinatide is a GLP-1 receptor agonist. In joint research conducted by the company and the research team, this compound demonstrated effects such as suppression of neuroinflammation, reduction of myelin damage, and neuroprotection in animal models of multiple sclerosis. The company also explained that the compound was found to inhibit the passage of activated immune cells across the blood-brain barrier.

Seulgi Lee, CEO of DND Pharmatech, stated, "This clinical trial is a significant turning point in expanding the therapeutic potential of pegsebrinatide beyond Parkinson's disease and Alzheimer's disease to include multiple sclerosis."

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