Trial begins for gut treatment drug

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A Fishers-based startup taking a unique approach to treating autism—via gut health—has achieved the major milestone of dosing the first patients. Unlike traditional pharmaceutical approaches, Scioto Biosciences Inc. aims to treat disorders by developing communities of “good” bacteria that exist in our bodies naturally. As Scioto was exploring its “bugs as drugs” approach to treat other conditions, Chief Executive Officer Dr. Joe Trebley says science unexpectedly opened a different door, revealing that the startup’s first product may actually be effective against autism.

The “bugs as drugs” method centers on the idea that good bacteria like probiotics “can serve in a meaningful therapeutic capacity,” says Trebley. SB-121 is the first product within Scioto’s novel microbiome platform, called Activated Bacterial Therapeutics. The main ingredient in SB-121 is a natural bacteria that babies are first exposed to in their mother’s breastmilk.

“It’s been fairly well-documented just in the last few years that the microbiome in patients with autism is very, very different than a healthy patient,” says Trebley. “The hypothesis is, by replacing and redeveloping that microbiome, you can improve the symptoms of autism. And we’re one of the first drugs to test that hypothesis.”

Scioto leaders were evaluating SB-121 in its pre-clinical stages for other indications when they discovered the bacteria was helping with the “gut-brain axis,” impacting things like social anxiety and other common symptoms of autism and behavioral issues. The finding inspired a pivot, and a Phase 1B clinical trial is now underway, evaluating the bacteria’s impact on 16 patients with autism spectrum disorder (ASD).

The main purpose of the trial is to evaluate the safety of SB-121, but it could also reveal the drug’s impact on other factors, such as behavioral issues associated with ASD, as well as GI health, “to help start to understand the specific population we can help,” says Trebley.

Scioto says the $26.5 million Series B financing just one year ago from South Korea-based Genome & Company, one of the leading microbiome companies in the world, blazed a trail to dosing the first humans with SB-121.