Neuraly, Inc., a wholly owned subsidiary of D&D Pharmatech, announced that the first patient has been dosed in a Phase 2 investigator-initiated trial (NCT07497399) evaluating pegsebrenatide (NLY01) for progressive multiple sclerosis.
The TAG-MS study, led by Dr. Ellen Mowry of Johns Hopkins University and to be conducted at multiple academic centers, will randomize about 120 patients 1:1 to once-weekly pegsebrenatide or placebo for 96 weeks in a double-blind, placebo-controlled design.
The primary endpoint is change from baseline in normalized brain parenchymal volume measured by MRI; key secondary endpoints include normalized gray matter and thalamic volumes, cortical thickness, Expanded Disability Status Scale scores and other central nervous system biomarkers.
Pegsebrenatide is described by the company as a proprietary long-acting GLP-1 receptor agonist, an analog of exendin-4 aimed at modulating neuroinflammation and protecting neurons. According to the company, preclinical studies showed inhibition of neuroinflammation and slowed progression in animal models, and prior Phase 2 data in 255 Parkinson’s patients suggested slower motor decline on UPDRS Part III, with larger effects in patients younger than 60.
