Supplementation with 1,3-1,6 β-glucan produced by the N-163 strain of black yeast, or N-163 β-glucan, yielded clinical benefits for patients with Duchenne muscular dystrophy (DMD), according to a study published in IBRO Neuroscience Reports.
Interleukin-13 (IL-13) and transforming growth factor-beta (TGF-β) levels decreased in the patients with DMD after treatment with N-163 β-glucan. In contrast, IL-13 and TGF-β levels increased in the control group, the researchers noted. When analysis was broken down into patients who received additional steroids, the difference between the N-163-β-glucan-treated and untreated groups were statistically significant (P <0.05) except for IL-13 with steroids (P =0.06), they added.
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Interleukin-6 (IL-6) levels decreased over time in both the treated and untreated patient groups, however, the decrease was significantly smaller in the treated group (P =0.03). When comparing the steroid use or no steroid use subgroups, the differences from baseline were not significant, however.
The N-163 β-glucan-treated group also had an increase in dystrophin levels when compared to baseline. The increase was as high as 32% in some patients.
A slight improvement in medical research council grading was observed in muscle strength in 12 out of the 18 patients in the treatment group (67%). In comparison, only 4 out of the 9 patients in the control group showed an improvement (44%).
“N-163 beta-glucan with and without steroids helped decrease IL-6, TGF-β and IL-13 and increase dystrophin levels along with improvement of muscle strength in subjects with DMD in this clinical study. While the benefits documented may help slow the rate of progression of this devastating disease, confirmation by longer and larger studies will help establish this agent as a disease-modifying agent for DMD,” the authors wrote.
A total of 27 patients were assigned to either a treatment group or control group. Of the patients who received treatment, 9 also received steroid treatment while the other 9 did not. Steroids were not received by 5 of the patients in the control group. No adverse events were recorded during the study.
Reference
Raghavan K, Dedeepiya VD, Srinivasan S, et al. Beneficial immune-modulatory effects of the N-163 strain of Aureobasidium pullulans-produced 1,3-1,6 Beta glucans in Duchenne muscular dystrophy: results of an open-label, prospective, exploratory case-control clinical study. IBRO Neurosci Rep. Published online July 8, 2023. doi:10.1016/j.ibneur.2023.06.007
