GAITHERSBURG, Md., United States – May 2026
Neuraly Inc. has announced that the first patient has been dosed in a Phase 2 investigator-initiated clinical trial (IIT) evaluating pegsebrenatide (NLY01) for the treatment of progressive multiple sclerosis (MS), marking a significant step forward in addressing neurodegeneration in chronic autoimmune diseases. The study will assess the safety, efficacy, and disease-modifying potential of this long-acting GLP-1 receptor agonist, targeting neuroinflammatory pathways, an area where current MS therapies remain limited. This milestone highlights growing industry focus on next-generation treatments that go beyond inflammation control to directly slow disease progression.
Phase 2 Trial Targets Neurodegeneration in MS
The Phase 2 study, designed as a randomized, double-blind, placebo-controlled trial, will enroll approximately 120 patients with progressive MS, a patient group with significant unmet medical need. Participants will receive once-weekly dosing of pegsebrenatide or placebo over 96 weeks, enabling long-term evaluation of disease progression and neurological outcomes.
The primary endpoint focuses on changes in brain parenchymal volume measured by MRI, a critical biomarker of brain atrophy and neurodegeneration, while secondary endpoints include gray matter volume, cortical thickness, and clinical disability scores. Unlike traditional MS treatments that primarily target immune-driven inflammation, this study aims to validate a therapy that directly addresses underlying neurodegenerative processes, which are the main drivers of disability in progressive MS.
Novel Mechanism Shows Strong Preclinical and Clinical Signals
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Pegsebrenatide (NLY01) is a proprietary GLP-1 receptor agonist engineered to modulate neuroinflammation and protect neuronal integrity, offering a differentiated mechanism in the MS treatment landscape. Preclinical studies have demonstrated its ability to reduce neuroinflammation and slow disease progression across models of multiple sclerosis, Alzheimer’s disease, and Parkinson’s disease, supporting its broad therapeutic potential.
In addition, prior Phase 2 data in Parkinson’s disease involving 255 patients indicated that pegsebrenatide may slow motor function decline, particularly in younger patients, strengthening the rationale for expanding development into MS. These findings position the drug as a potential disease-modifying therapy, rather than a symptomatic treatment, which is a major gap in current neurological care.
Strategic Expansion in Neurodegenerative Disease Pipeline
Neuraly Inc. is leveraging this trial to expand its footprint in neurodegenerative disease therapeutics, an area with high clinical demand and limited effective treatment options. The study is being led by leading academic investigators, including researchers from Johns Hopkins University, ensuring strong scientific oversight and credibility.
With multiple sclerosis affecting over 2.8 million people globally, and progressive forms lacking effective interventions, successful outcomes from this trial could significantly reshape the treatment landscape. The company’s strategy reflects a broader industry trend toward targeting root biological mechanisms such as neuroinflammation and neuronal survival, rather than focusing solely on immune suppression, signaling a paradigm shift in treating chronic neurological diseases.
Source: Neuraly press release
