Scioto Biosciences, a subsidiary of Genome & Company (CEO Bae Ji-soo and Park Han-soo), a global immunotherapy specialist, successfully administered its first patient dose of brain disease microbiome treatment ‘SB-121’ on the 16th, local time in the United States. In conclusion, we are one step closer to developing an innovative new drug (first-in-class) in the field of autism.
Brain disease microbiome treatment ‘SB-121’ is a ‘first-in-class’ autism spectrum (ASD) treatment using live bacteria-based medicine (LBP, Live Biotherapeutic Products), which is known to have an effect on alleviating autism in preclinical trials. Increased secretion of oxytocin has been confirmed. ‘SB-121’ is Scioto Bioscience’s proprietary platform ‘ABT Platform’ (Activated Bacterial Therapeutics) that maximizes the efficacy of microbiome strains with Lactobacillus reuteri (L.reuteri) strains found in breast milk of healthy mothers. It is characterized by the application of technology to increase the stability and efficacy of the strain in the body.
In this clinical trial, Scioto Bioscience plans to confirm the safety and tolerability of ‘SB-121’ in a large number of autism patients and also check changes in oxytocin levels in the body, known as the main mechanism. Cincinnati Children’s Hospital Medical Center, where the clinical trial is taking place, is one of the world’s most prestigious children’s hospitals, ranking among the top five hospitals in the children’s hospital category in the 2021-22 Best Hospitals in America evaluation announced by U.S. News & World Report. It’s one place.
‘SB-121’ aims to enter phase 2 clinical trials for autism in 2022, starting with the first patient administration. In addition, we are also entering phase 1/2 clinical trials for patients with neonatal necrotizing enterocolitis (NEC), which was approved by the FDA in November of last year, and are planning to expand the indications for ‘SB-121’.
Joe Trebley, CEO of Scioto Bioscience, a subsidiary of Genome & Company, said, “This clinical trial is a significant achievement that demonstrates the possibility of developing a treatment for microbiome brain and nerve diseases based on the Gut-Brain-Axis theory.” “We will reach our goal of developing a first-in-class innovative new drug in the field of autism through our ABT platform technology and ‘SB-121’.”
CEO Bae Ji-soo of Genome & Company said, “Genome & Company has infinite growth potential as it is developing a pipeline of microbiome treatments for various indications, ranging from immune-oncology microbiome treatments to brain diseases, obstetric diseases, and skin diseases.” He said, “In the future, we will strive to become a global bio company by not only developing immuno-anticancer microbiome treatments, but also securing indications for various disease groups and developing new target immuno-anticancer drugs.”
Meanwhile, according to the Centers for Disease Control and Prevention (CDC), one in 54 children worldwide will be diagnosed with autism in 2020. Autism is a disease that occurs in all races, ethnicities, and countries, and there is no clear cure for it so far.
Source: Pangyo Techno Valley Official Newsroom
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