May 5, 2026 — Leads & Copy — Neuraly, Inc., a wholly owned subsidiary of D&D Pharmatech, Inc. (KOSDAQ: 347850), has announced the first patient has been dosed in a Phase 2 Investigator-Initiated Trial (IIT) of pegsebrenatide (NLY01) for the potential treatment of multiple sclerosis (MS).
The Phase 2 study will evaluate Neuraly’s long-acting GLP1 receptor agonist.
Multiple sclerosis is a chronic, progressive autoimmune disease affecting the central nervous system (CNS). It impacts over 2.8 million people globally, typically starting between 20 and 40 years of age.
MS involves immune-mediated inflammation of the myelin sheath, disrupting neural signaling and leading to neurodegeneration and disability. Current treatments primarily target inflammatory activity, but effective therapies for neurodegeneration are limited, especially for progressive forms of MS.
Pegsebrenatide is a proprietary, long-acting GLP-1 receptor agonist designed to modulate neuroinflammatory pathways and protect neurons. Preclinical studies showed it inhibited neuroinflammation and slowed disease progression in animal models of multiple sclerosis, Alzheimer’s disease, and Parkinson’s disease.
Clinical data from a Phase 2 trial in 255 Parkinson’s disease patients suggested pegsebrenatide may slow motor dysfunction progression, particularly in patients under 60. These results, along with preclinical findings, support its development 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 from Johns Hopkins University and conducted at multiple academic medical centers.
The randomized, placebo-controlled, double-blind study will involve approximately 120 patients with progressive MS, 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. Key secondary endpoints include changes in normalized gray matter, thalamic volumes, cortical thickness, and clinical outcomes including the Expanded Disability Status Scale (EDSS) and other CNS biomarkers.
Seulki Lee, CEO of Neuraly, said the company is excited to advance the clinical development of pegsebrenatide with leading MS research centers. Lee added that patients with progressive MS face significant unmet medical needs, with neuroinflammation driving disease progression. Pegsebrenatide represents a differentiated therapeutic strategy aimed at addressing the underlying neuroinflammatory processes that drive neurodegeneration, and has the potential to expand the treatment paradigm for progressive MS and other neurodegenerative diseases.
Pegsebrenatide (NLY01) is a long-acting analogue of exendin-4, a glucagon-like peptide-1 receptor (GLP-1R) agonist that limits neurodegeneration by suppressing neuroinflammation. Neuraly is developing it as a potentially disease-modifying agent for multiple neurodegenerative disorders.
Neuraly, Inc. is 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.
Source: Neuraly
