Scioto Biosciences, a clinical stage company developing innovative therapies to transform the delivery of microbiome therapeutics, announced the publication in the journal Scientific Reports of results from a Phase 1b study of their lead product SB-121 in patients with Autistic Spectrum Disorder (ASD).
The top-line results of the study were announced last summer. The first-in-human study was double-blind, placebo controlled, 28-day crossover study of the safety and tolerability of SB-121. SB-121 is a novel formulation of Lactobacillus reuteri (Lr) and was given to patients 15 to 45 years of age diagnosed with ASD.
Lr is a species of bacteria that is often found in breastmilk. With the results now published, the study demonstrated that SB-121 was safe and well-tolerated. The study also showed treatment-associated improvements in the Vineland-3 adaptive behavior assessment, measures of eye tracking and increases in peripheral oxytocin. Oxytocin is a natural hormone that, among many functions, encourages bonding and social interaction.
The study was performed by Dr. Craig Erickson MD at the Cincinnati Children’s Hospital. Dr. Erickson is the corresponding author on the paper. Additional authors include Lauren Schmitt PhD, Elizabeth Smith PhD, Ernest Pedapati MD MS, Paul Horn PhD, Meredith Will PhD, Martine Lamy MD PhD, and Lillian Barber from Cincinnati Children’s Hospital and Joe Trebley PhD, Kevin Meyer, Mark Heiman PhD, Korbin West PhD, Phoevos Hughes JD, and Sanjeev Ahuja MD from Scioto Biosciences.
“We are very pleased to have this study accepted for publication. It is an exciting result that certainly warrants further investigation in a larger Phase II study. We look forward to continuing to help move this forward in the clinic so that we can eventually get it to the patients that so desperately need it,” said Dr. Erickson.
“Scioto is incredibly grateful for the team at Cincinnati Children’s Hospital. We are proud to have published this important work alongside them. The peer-review process is such a critical part of science. It is incredibly gratifying to have this study published in such a well-cited journal,” explained Joe Trebley, PhD, CEO of the Company. Trebley also said that hope to begin a Phase II study in the 2nd half of this year.
According to the Center for Disease Control (CDC) about 1 in 44 children have been identified with ASD, and prevalence in adults continues to grow creating the bulk of the economic burden of the disorder. Estimates of economic costs in the US only are in the 100’s of billions of dollars.
