GAITHERSBURG, Md. — Neuraly, Inc., a wholly owned subsidiary of D&D Pharmatech, Inc. (KOSDAQ: 347850), announced that the first patient has been dosed in a Phase 2 Investigator-Initiated Trial (IIT) evaluating pegsebrenatide (NLY01), Neuraly’s long-acting GLP1 receptor agonist, for the potential treatment of patients with multiple sclerosis (MS).
Multiple sclerosis is a chronic and progressive autoimmune disease of the central nervous system (CNS) affecting more than 2.8 million people worldwide, with onset typically occurring between the ages of 20 and 40. The disease is characterized by immune-mediated inflammation of the myelin sheath, the protective covering of nerve fibers, disrupting neural signaling and ultimately leading to neurodegeneration and disability. While current therapies primarily target inflammatory activity, effective treatments addressing neurodegeneration remain limited, particularly relevant to progressive forms of MS.
Pegsebrenatide is a proprietary, long-acting GLP-1 receptor agonist designed to modulate neuroinflammatory pathways and protect neurons. In preclinical studies, pegsebrenatide demonstrated the ability to inhibit neuroinflammation and slow disease progression in animal models of multiple sclerosis, Alzheimer’s disease, and Parkinson’s disease.
Clinical data from a previous Phase 2 trial in 255 patients with Parkinson’s disease suggested that treatment with pegsebrenatide may slow the progression of motor dysfunction, as measured by UPDRS Part III, with the most pronounced effects observed in patients younger than 60 years of age. Together with extensive preclinical findings, these results support the continued development of pegsebrenatide as a potential disease-modifying therapy for neurodegenerative conditions, including progressive MS.
The study NCT07497399, titled “Targeting Agonists of Glucagon-like peptide-1 receptor for Multiple Sclerosis (TAG-MS): A Phase 2, Randomized, Double-Blind, Parallel-Arm Study,” will be led by Dr. Ellen Mowry, Professor of Neurology and Epidemiology at Johns Hopkins University, and will be conducted at multiple leading academic medical centers.
In this randomized, placebo-controlled, double-blind study, approximately 120 patients with progressive MS will be randomized 1:1 to receive pegsebrenatide or placebo once-weekly for 96 weeks. The primary endpoint is the change from baseline in normalized brain parenchymal volume, measured by MRI, as an indicator of progressive brain atrophy and neurodegeneration. Key secondary endpoints will include changes in normalized gray matter, thalamic volumes, and cortical thickness, as well as clinical outcomes including the Expanded Disability Status Scale (EDSS) and other CNS biomarkers.
“We are excited to advance the clinical development of pegsebrenatide in collaboration with leading MS research centers,” said Seulki Lee, CEO of Neuraly. “Patients with progressive MS continue to face significant unmet medical needs, with neuroinflammation playing a central role in driving disease progression. Pegsebrenatide represents a differentiated therapeutic strategy aimed at addressing the underlying neuroinflammatory processes that drive neurodegeneration. We believe this program has the potential to expand the treatment paradigm for progressive MS and other neurodegenerative diseases.”
About Pegsebrenatide (NLY01)
Pegsebrenatide is a proprietary long-acting analogue of exendin-4, a glucagon-like peptide-1 receptor (GLP-1R) agonist that limits neurodegeneration by suppressing neuroinflammation, thus slowing disease progression in animal models of Parkinson’s and Alzheimer’s disease and multiple sclerosis. Pegsebrenatide is being developed as a potentially disease-modifying agent for the treatment of multiple neurodegenerative disorders.
About Neuraly
Neuraly, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies that address the underlying causes of neurodegenerative diseases. The company’s pipeline targets key biological mechanisms such as neuroinflammation and neuronal survival to slow or halt disease progression. For more visit https://www.neuralymed.com/.
Neuraly Contact
Neuraly, Inc.
Ben Gibson
240-937-5876
[email protected]