Fri Sep 20 08:14:52 UTC 2024: ## Japanese Beta Glucan Shows Promise for Treating Rare and Auto-Immune Diseases
**TOKYO** – A Japanese-made food supplement, Neu-REFIX Beta glucan, has received both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of Duchenne muscular Dystrophy (DMD). These designations pave the way for clinical trials in the U.S. to potentially bring this supplement to market.
Neu-REFIX, an exo-polysaccharide produced from a specific strain of Aureobasidium Pullulans, has been commercially available in Japan since 2018 as a food additive. Studies have shown its potential benefits in treating DMD, a rare genetic disease affecting 1 in 5000 male births.
The anti-inflammatory properties of Neu-REFIX, initially discovered through DMD research, have sparked further investigation into its potential for other conditions. This includes autoimmune diseases such as Multiple Sclerosis and common skin disorders like Psoriasis Vulgaris.
While RPDD and ODD are not FDA approvals, they represent a significant validation of the supplement’s potential and provide several advantages, including market exclusivity, access to grants and research support, and a fast-tracked approval process.
The research team behind Neu-REFIX hopes these designations will facilitate collaboration with organizations to conduct clinical trials and ultimately secure FDA approval for this promising treatment option.
First Piper 