Scioto Biosciences: Pioneering Gut-Brain Solutions for a Healthier Future
In the dynamic landscape of health innovation, some companies stand out not only for the scientific rigor of their work but also for the human impact they strive to achieve. A new member of the StartUp Health community, Scioto Biosciences – under the leadership of its passionate founders Joe Trebley, PhD, and Jim Schulz – is one such company. Originating from a quest to save the most vulnerable newborns, Scioto has embarked on an extraordinary journey to unlock the therapeutic potential of the gut microbiome, with an initial focus on addressing the unmet needs of individuals with autism spectrum disorder (ASD).
By Nicole Kinsey
The Inspiration: A Gut-Brain Connection Ignites a New Hope
Scioto’s story began in the neonatal intensive care unit (NICU) at Nationwide Children’s Hospital (NWCH). The founding team witnessed firsthand the devastating effects of necrotizing enterocolitis (NEC), a life-threatening condition that ravages the intestines of premature infants. Faced with limited treatment options and a high mortality rate, the team was driven to find innovative ways to promote gastrointestinal healing by modulating the gut microbiome.
However, their research took an unexpected and transformative turn. As they developed their microbiome technology, they observed signals suggesting its impact extended beyond the gut, influencing the brain. This pivotal discovery illuminated the burgeoning field of the gut-brain connection, hinting at the possibility that their platform could offer neuroprotective effects.
This revelation led the team to confront another significant and urgent challenge: autism spectrum disorder (ASD). Millions of families navigate the complex behavioral, emotional, and social challenges of ASD, often with limited access to effective treatments for core symptoms. The prospect of a safe, microbiome-based therapy offering real, measurable benefits was an opportunity too compelling to ignore.
Scioto expanded its mission, committing to explore the gut microbiome as a new frontier in neurodevelopmental care, while steadfastly maintaining its initial commitment to vulnerable neonates. This dual focus reflects a deep understanding of the interconnectedness of health and the potential for their foundational technology to address diverse medical needs. This dual focus is driven by a shared personal connection within their team, with experiences in the NICU and with autism in their families, reinforcing the urgency and personal investment in their work.
Origin Story: From the NICU to Biotech Innovation
The inception of Scioto Biosciences in 2017 was driven by a powerful blend of scientific insight and entrepreneurial vision, spearheaded by co-founders Joe Trebely and Jim Schulz. The combination of their diverse backgrounds, spanning research and development, public accounting and leadership roles in pharmaceutical and medical device companies, provided a unique perspective on the healthcare landscape. Their experience in bringing impactful medicines to patients ignited a passion for innovation that directly addresses critical unmet needs.
Supported by significant NIH funding, the company’s early focus was on leveraging the gut microbiome to combat the devastation of NEC in premature infants. However, a pivotal “aha moment” occurred as the team observed the potential for their microbiome technology to exert neuroprotective effects. This discovery dramatically expanded the company’s horizons, revealing the possibility of addressing complex neurodevelopmental disorders like ASD.
What truly differentiates Scioto is its foundational technology: the proprietary Activated Bacterial Therapeutic (ABT) platform. This innovative approach enhances the delivery and efficacy of beneficial bacteria within the gut. By improving the survival and targeted action of probiotic strains, the ABT platform offers a significant advantage over traditional, less sophisticated microbiome interventions. This unique delivery mechanism, coupled with the team’s scientific expertise and strategic leadership, forms the core of Scioto’s distinct advantage in the pursuit of novel gut-brain therapeutics.
Under the Hood: SB-121 - A Superhero Smoothie for the Gut
Scioto’s lead product, SB-121, is designed to be a user-friendly therapeutic that harnesses the power of a specific beneficial bacterium, Lactobacillus reuteri (LR). To explain SB-121 simply, imagine your body as a bustling city, with your stomach and intestines as the central hub for food processing and even influencing your feelings. Within this hub reside trillions of tiny helpers called bacteria, some of which are crucial for digestion, immunity, and even brain health.
In individuals with ASD or premature infants, these beneficial bacteria may not function optimally. SB-121 acts like a "superhero smoothie" for the gut, composed of:
A friendly bacteria (LR): Known for its potential to promote gut health and influence neural pathways.
A special sugar: Designed to help the bacteria thrive and effectively colonize the gut.
Protective elements: Enhancing the survival and growth of the beneficial bacteria.
The administration of SB-121 is straightforward. It involves combining two small vials – one containing the bacteria and the other a specially formulated "slurry" – shaking the mixture, allowing it to sit briefly, and then drinking it. The formulation can also be mixed with common liquids like apple juice, cranberry juice, or water, making it easy for various patient populations to consume.
Early clinical signals have been encouraging. In a Phase Ib study involving individuals with ASD, SB-121 demonstrated positive safety and efficacy signals. Notably, one patient, typically hyper-fixated on hockey, showed improved social interaction and broader conversational topics while on the therapy. This anecdotal evidence underscores the potential of SB-121 to positively impact core symptoms of ASD.
What's Next: A Future Powered by the Microbiome
Scioto Biosciences is at a pivotal stage. Having completed a promising Phase Ib clinical trial for SB-121 in ASD, the company is now focused on advancing to a larger Phase II study. Concurrently, preclinical efforts for their NEC indication are nearing completion, with plans to initiate a Phase I study, pending FDA approval.
The team envisions a future where SB-121 becomes a routine part of daily life for individuals with autism, offering a safe and natural way to improve their socialization, daily living skills, and overall wellbeing. He hopes to see children with ASD navigate school and social situations with greater ease and less anxiety, ultimately leading to increased independence. In the NICU, Scioto aims to provide a much-needed intervention to protect vulnerable premature infants from the devastating consequences of NEC.
Recognizing the profound impact of the microbiome on overall health, Scioto’s broader vision aligns with multiple Health Moonshot Communities, including Brain Health, Food as Medicine, and Children’s Health. The company sees significant potential to expand its platform into new indications, addressing both gastrointestinal and neuroprotective needs. Their foundational bacterial strain is viewed as a key component for building a resilient and healthy microbiome.
While the path forward involves navigating the complexities of clinical trials and regulatory landscapes, the Scioto team is driven by the profound unmet needs they are addressing and the potential to revolutionize treatment paradigms through microbiome-based therapies. Their journey underscores the importance of interdisciplinary collaboration, scientific curiosity, and an unwavering commitment to improving the lives of patients and their families. The world is beginning to recognize the immense potential of the gut-brain axis, and Scioto Biosciences is at the forefront of this exciting new frontier.
Connect with Scioto Biosciences via email
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Published: May 15, 2025
