Scioto Biosciences has announced positive topline results from their phase 1b trial evaluating the novel probiotic SB-121 (Lactobacillus reuteri with dextran microparticles and maltose) in individuals with autism spectrum disorder (ASD).
The trial represents the first clinical validation of the company’s proprietary Activated Bacterial Therapeutics (ABT) platform for delivering “best-in-class, live therapeutic bacteria to the gut,” the company noted in a news release.
“This study is an important milestone in the microbiome field, particularly as it relates to the gut-brain axis,” Joe Trebley, PhD, founder and CEO of Scioto, said in the release.
“Gastrointestinal disorders are common in people with autism, and we think this product will have a very enviable safety profile,” Trebley told Medscape Medical News.
Compelling Data?
Neurologic and gastrointestinal disorders often coexist. Recent evidence suggests a bacterial imbalance in the gut may be associated with, precede, or exacerbate core symptoms of autism.
This first-in-human study of SB-121 was a randomized, double-blind, placebo-controlled, 28-day daily-dose crossover study that evaluated the safety and tolerability of the novel product in 15 people aged 15 to 45 years who had been diagnosed with ASD.
Results showed that SB-121 was safe and well tolerated, which was the primary goal of the phase 1b trial.
The most common adverse events (AEs), irrespective of treatment group, were abdominal pain, vomiting, and diarrhea. Most AEs were mild, and none were serious or severe. No participant discontinued the trial because of AEs.
The study provides preliminary evidence of SB-121-associated improvements in the Vineland-3 adaptive behavior assessment and in objective measures of eye tracking, the company reported.
“Looking at some of the secondary endpoints, the Vineland and also the objective measures, we think we have a really compelling dataset,” Trebley said.
Craig Erickson, MD, director at the Kelly O’Leary Center for Autism Spectrum Disorders, Cincinnati Children’s Medical Center, Ohio, served as principal investigator for the trial.
The fact that the study enrolled “very rapidly [is] a testament to the unmet medical need and patient/caregiver interest in potentially safe, well tolerated, and effective medicines in this field,” Erickson said in the release.
The company plans to publish full results of the phase 1b trial and will launch a phase 2 study sometime later this year or in early 2023.
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