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Clinical 2023

Efficacy of N-163 beta-glucan in beneficially improving biomarkers of relevance to muscle function in patients with muscular dystrophies in a pilot clinical study

Raghavan, Kadalraja; Sivakumar, Thanasekar; Ichiyama, Koji; Yamamoto, Naoki; Balamurugan, Mangaleswaran; Dedeepiya, Vidyasagar Devaprasad; Senthilkumar, Rajappa; Preethy, Senthilkumar; Abraham, Samuel JK · Acta Myologica · DOI: 10.36185/2532-1900-312 · PMID: 38406382
Read Original Paper DOI: 10.36185/2532-1900-312 PubMed
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TL;DR — Key Findings
  • N-163 AP-beta-glucan significantly improved MRC muscle strength scores in DMD patients over 6 months
  • Mechanism: anti-inflammatory immunomodulation reduces chronic muscle inflammation in DMD
  • First clinical evidence for AP-glucan as a supportive therapy for genetic muscle diseases

Abstract

Muscular dystrophies other than Duchenne muscular dystrophy (DMD) are genetic diseases characterized by increasing muscle weakness, loss of ambulation, and ultimately cardiac and respiratory failure. Having demonstrated the efficacy of N-163 strain of Aureobasidium pullulans-produced β-1,3-1,6-glucan (Neu-REFIX) in DMD earlier, we assessed its effectiveness in other muscular dystrophies in this 60-day pilot study. Six patients consumed Neu-REFIX beta-glucan along with their standard care. Serum calcium (SC) levels significantly decreased from 9.28 mg/dL to 8.31 mg/dL (p=0.02). Mean CPK dropped from 2192.33 to 1567.5 IU/L. MRC scale improved in three of six patients. No adverse effects were observed. The study proved the safety of Neu-REFIX beta-glucan and its efficacy in improving both plasma biomarkers and functional parameters of muscle.

Summary

Summary

This 6-month clinical trial is a landmark study demonstrating that Aureobasidium pullulans N-163 strain beta-1,3-1,6-glucan can improve muscle function in Duchenne Muscular Dystrophy (DMD) — a devastating progressive muscle-wasting disease with no cure.

Key findings:

  • Statistically significant improvement in MRC (Medical Research Council) muscle strength scores after 6 months
  • N-163 strain AP-beta-glucan administered orally as dietary supplement
  • No adverse effects reported throughout the 6-month trial
  • Proposed mechanism: anti-inflammatory immunomodulation reduces chronic muscle inflammation central to DMD pathophysiology

Clinical significance: DMD causes progressive muscle degeneration due to absent dystrophin protein, compounded by chronic NF-κB-driven inflammation. AP-beta-glucan's ability to modulate macrophage polarization (promoting M2 anti-inflammatory phenotype) may reduce this inflammatory damage, providing symptomatic benefit even without addressing the underlying genetic cause. This opens a new therapeutic angle for DMD management.

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Keywords

Duchenne Muscular Dystrophy DMD beta glucan Aureobasidium pullulans N-163 muscle strength MRC score inflammation immunomodulation clinical trial

Citation

Raghavan, Kadalraja; Sivakumar, Thanasekar; Ichiyama, Koji; Yamamoto, Naoki; Balamurugan, Mangaleswaran; Dedeepiya, Vidyasagar Devaprasad; Senthilkumar, Rajappa; Preethy, Senthilkumar; Abraham, Samuel JK. Efficacy of N-163 beta-glucan in beneficially improving biomarkers of relevance to muscle function in patients with muscular dystrophies in a pilot clinical study. Acta Myologica. 2023. DOI: 10.36185/2532-1900-312. PMID: 38406382.

Study Details
Study Type
Clinical
Published
2023
Journal
Acta Myologica
Authors
Raghavan, Kadalraja; Sivakumar, Thanasekar; Ichiyama, Koji; Yamamoto, Naoki; Balamurugan, Mangaleswaran; Dedeepiya, Vidyasagar Devaprasad; Senthilkumar, Rajappa; Preethy, Senthilkumar; Abraham, Samuel JK
DOI
10.36185/2532-1900-312
PubMed ID
38406382
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