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CD206-Targeted Liposomal Myelin Basic Protein Peptides in Patients with Multiple Sclerosis Resistant to First-Line
Alexey Belogurov1,2,3, Konstantin Zakharov4, Yakov Lomakin1,2
1M.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, Moscow, Russia.
Xemys, a novel therapy for multiple sclerosis (MS), demonstrated safety and tolerability in a Phase I trial. This antigen-specific treatment warrants further investigation for relapsing-remitting and secondary progressive MS patients.
Area of Science:
- Neuroimmunology
- Demyelinating Diseases
- Drug Development
Background:
- Experimental autoimmune encephalomyelitis (EAE) is a model for multiple sclerosis (MS).
- CD206-targeted liposomal delivery of myelin basic protein (MBP) sequences (Xemys) previously suppressed EAE in rats.
- Patients with relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) often require new therapies if first-line treatments fail.
Purpose of the Study:
- To assess the safety and tolerability of Xemys in patients with MS.
- To evaluate Xemys as a potential disease-modifying therapy for MS.
- To explore the effects of Xemys on clinical and MRI outcomes in MS patients.
Main Methods:
- A Phase I, open-label, dose-escalating study.
- 20 patients with RRMS or SPMS received weekly subcutaneous injections of Xemys.
- Clinical assessments, MRI, and serum cytokine levels were monitored.
Main Results:
- Xemys was safe and well-tolerated up to 900 μg.
- No significant changes in Expanded Disability Status Scale (EDSS) or T2 lesions were observed.
- A significant increase in active gadolinium-enhancing lesions was noted at weeks 7 and 10.
Conclusions:
- Xemys is safe and well-tolerated in MS patients.
- Further development of Xemys as an antigen-specific therapy for MS is supported.
- Observed changes in MRI lesions and cytokines suggest potential immunomodulatory effects.
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