Genome & Company, a microbiome specialist company, announced on the 4th that the Phase 1 clinical trial results of the brain disease microbiome therapeutic ‘SB-121,’ developed by its subsidiary Scioto Bioscience, have been published in the international journal Scientific Reports. Scientific Reports is an online open-access journal affiliated with Nature and was the 5th most cited international journal in 2021, with 696,000 citations.
SB-121 is a therapeutic agent targeting autism spectrum disorder (ASD). It enhances the stability and efficacy of the Lactobacillus reuteri strain found in the breast milk of healthy mothers by applying Scioto’s proprietary 'ABT platform' technology to the strain.
The Phase 1 clinical trial of SB-121 was conducted on 15 individuals diagnosed with autism spectrum disorder using a double-blind, placebo-controlled, and crossover design, with topline results announced in May last year. This paper includes not only the primary endpoints of safety and tolerability but also results from the VinelandTM-Ⅲ adaptive behavior assessment, eye-tracking tests, and blood oxytocin measurements conducted on clinical participants.
Joe Trebley, CEO of Scioto, stated, “This clinical trial is a meaningful achievement demonstrating the potential for developing microbiome-based brain and neurological disease therapeutics based on the Gut-Brain-Axis theory. Through the ABT platform technology and ‘SB-121,’ we aim to approach the goal of developing a First-in-Class innovative drug in the field of autism.” Youngjin Seo, CEO of Genome & Company, also said, “The publication of this paper is a significant result showing the potential for treatment of ASD, for which there are currently no existing therapies. We will work closely with Scioto to enter Phase 2 clinical trials of SB-121 in the second half of this year to verify its efficacy and expand indications to various diseases such as neonatal necrotizing enterocolitis (NEC).”
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