FISHERS, Ind.–(BUSINESS WIRE)–Scioto Biosciences, Inc. (Scioto), a clinical-stage biotechnology company dedicated to innovative research and development in the field of microbiome therapeutics for various diseases, announced top-line results of its Phase Ib trial of lead asset, SB-121, based on its novel microbiome delivery platform, Activated Bacterial Therapeutics (ABT), which is designed to deliver best-in-class, live therapeutic bacteria to the gut.
This first-in-human study was a randomized, double-blind, placebo-controlled, 28-day daily-dose crossover study of the safety and tolerability of SB-121 (Lactobacillus reuteri with dextran microparticles and maltose) in patients, ages 15 to 45 years, diagnosed with autism spectrum disorder (ASD).
The study was conducted at the Cincinnati Children’s Medical Center, with Craig Erickson, MD as the Principal Investigator. Dr. Erickson is Professor of Psychiatry and Director of Research at the Kelly O’Leary Center for Autism Spectrum Disorders and Division of Child and Adolescent Psychiatry at Cincinnati Children’s Hospital Medical Center.
Top-line results from the study demonstrated that SB-121 was safe and well tolerated. The most common adverse events, irrespective of treatment group, were abdominal pain, vomiting, and diarrhea. The majority of adverse events were mild, and none were serious or severe. There were no discontinuations due to adverse events. Additionally, there were treatment-associated improvements noted in the Vineland-3™ adaptive behavior assessment and in measures of eye tracking.
“This study enrolled very rapidly, a testament to the unmet medical need and patient/caregiver interest in potentially safe, well tolerated and effective medicines in this field. These results prompt a way forward to Phase II for SB-121,” said Dr. Erickson.
“This study and its outcome reinforce our confidence in SB-121 and in our partners at Scioto and their ability to advance the development of this promising treatment,” said Jisoo Pae, MD, Founder & CEO of Genome & Company, who supported Scioto’s Series B financing.
“This study is an important milestone in the microbiome field, particularly as it relates to the gut-brain axis. These results also support the path to a Phase II study of SB-121 sometime later this year or in early 2023 as well as the clinical validation of our ABT platform. We will discuss the results with the FDA and plan to present the details of this Phase Ib study in a future scientific forum,” said Joe Trebley, PhD, Founder & CEO of Scioto.
About Scioto Biosciences, Inc.
Based in Fishers, Indiana, Scioto Biosciences is a clinical-stage biotechnology company developing innovative therapies devoted to having a transformative impact on the delivery of live bacterial therapeutics (LBTs). Lead product, SB-121, is in clinical development for autism spectrum disorder. Scioto’s Activated Bacterial Therapeutic (ABT) Platform has the potential to enhance efficacy wherever LBTs are used such as gastrointestinal health, diabetes, neurological disorders, alternatives to in-feed antibiotics (in livestock) and others. For more information, visit http://sciotobiosciences.com/.