# A Novel Probiotic Platform to Treat Necrotizing Enterocolitis

> **NIH NIH R44** · SCIOTO BIOSCIENCES, INC. · 2020 · $1,134,186

## Abstract

PROJECT SUMMARY
Necrotizing enterocolitis (NEC) is a devastating disease affecting premature infants. Approximately 10% of
infants born under 1500 g will develop the disease, and mortality for affected infants is 20-30%. Despite decades
of research, the morbidity and mortality of the disease remain generally unchanged. Current treatment and
preventive approaches for NEC remain suboptimal, with no FDA-approved therapies for the indication. NEC is
the leading cause of death from gastrointestinal disease in premature infants, with an associated cost of $500
million to $1 billion annually for treatment in the US alone. Given the morbidity and mortality associated with the
disease and the resulting economic burden, novel approaches for the prevention of NEC are critically needed.
Probiotics hold enormous potential for promoting human health and treating disease, including NEC. Current
probiotic approaches are inadequate due to the lack of persistence in the gut which necessitates multiple
administrations of the probiotic and results in limited efficacy. This creates a safety concern for this vulnerable
neonatal population since probiotic administration has been linked to bacteremia. Concern for potential sepsis
is one of the major factors limiting widespread use of probiotics by neonatologists to prevent NEC. Scioto
Biosciences and their research partners at the Research Institute at Nationwide Children’s Hospital (RINCH) are
developing a novel probiotic approach, SB-121, that allows for persistent probiotic benefit from just a single dose
well in advance of NEC and the corresponding changes in intestinal permeability, thus dramatically reducing the
risk of bacteremia. SB-121 is a biofilm of Lactobacillus reuteri, a persistent community of bacteria, adhered to
porous microspheres enabling increased probiotic stability.
In a successful Phase I program, Scioto Biosciences met all Phase I milestones resulting in: 1) the production of
a stable SB-121 prototype that supports clinical use of the platform; 2) the in vivo demonstration of the
effectiveness of SB-121 in preventing NEC; and 3) the identification of optimal SB-121 dosing. Completion of
the Phase I program was critical to supporting the proposed Phase II program that will focus on the execution of
studies in neonatal pigs. This will inform clinical studies as neonatal pigs are similar in size and intestinal maturity
to premature humans. Phase II efforts will include the characterization of the impact of SB-121 on the microbiome
and metabolome of healthy full-term and premature pigs (Aim 1) and the assessment of the ability of SB-121 to
prevent NEC (Aim 2). Successful execution of the Phase II program will provide critical dose, safety, and efficacy
data packages that will be instrumental to the design and execution of a subsequent IND-enabling program, as
well as clinical trials supporting the clinical use of SB-121 for the prevention of NEC.

## Key facts

- **NIH application ID:** 9996707
- **Project number:** 5R44GM122130-03
- **Recipient organization:** SCIOTO BIOSCIENCES, INC.
- **Principal Investigator:** GAIL E BESNER
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,134,186
- **Award type:** 5
- **Project period:** 2017-08-01 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9996707

## Citation

> US National Institutes of Health, RePORTER application 9996707, A Novel Probiotic Platform to Treat Necrotizing Enterocolitis (5R44GM122130-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9996707. Licensed CC0.

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