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Small Biz Grant Funds Pre-Term Gut Microbe Therapy

Microbiome graphic

(Tony Webster, Flickr)

21 Aug. 2019. National Institutes of Health is supporting development of an extended-release probiotic treatment for necrotizing enterocolitis, an intestinal disease affecting premature infants. National Institute of General Medical Sciences, or NIGMS, part of NIH, is awarding $2.3 million to Scioto Biosciences Inc. in Indianapolis and Nationwide Children’s Hospital in Columbus, Ohio for the two-year project.

Necrotizing enterocolitis occurs almost entirely in pre-term infants, where the wall of the intestine is invaded by bacteria, becoming infected and inflamed. Damage to the intestinal wall can lead to perforation of the intestine and leakage into the abdomen, resulting in large-scale infection and death. Children’s Hospital of Los Angeles says necrotizing enterocolitis occurs in about 10 percent of premature infants, or 2,000 to 4,000 births.

Scioto Biosciences is developing treatments for disease associated with changes in microbial communities in the gut. The company creates probiotic treatments, or live bacterial cultures, designed to last for extended periods in the gut, where most probiotics require frequent doses to remain effective.  Scioto’s technology takes advantage of bacteria’s natural formation of biofilms, self-supporting communities of microbes that can survive for long periods of time. The company seeds therapeutic bacteria around porous micro-scale particles to encourage biofilm growth, then administers the biofilms as single-dose treatments.

Scioto’s lead product, code-named SB-121, is in preclinical development as a treatment for a number of disorders, including clostridium difficile infections and childhood obesity, as well as autism. The company conducted small-animal tests of SB-121 to determine its feasibility for treating necrotizing enterocolitis, funded by NIGMS, and determine optimal dosing.

The new grant extends the research into new-born pigs, with organs similar in size and function as humans. Tests will assess SB-121’s ability to prevent necrotizing enterocolitis, as well as gauge the impact of the treatment on microbial communities in full-term and premature pigs.

Scioto Biosciences is a two year-old company formed by Monon Bioventures, a life science start-up accelerator in Indianapolis, and the research arm of Nationwide Children’s Hospital, collaborating with Scioto in the research for NIGMS. Gail Besner of Nationwide Children’s Hospital, a scientific founder of Scioto and co-principal investigator of the project, says in a statement e-mailed to Science and Enterprise, “This funding will be used to support important pre-clinical experiments prior to treating necrotizing enterocolitis in pre-term infants. The work here will be critical to inform upcoming clinical work to help combat these deadly GI disorders as well as other diseases.”

The award from NIGMS is made under NIH’s Small Business Innovation Research, or SBIR, program that sets aside a portion of its overall research funding for small U.S.-based companies with science-based products. In Fiscal Year 2017, NIH set-aside about 3.7 percent of its research funding, or more than $1 billion, for SBIR and related Small Business Technology Transfer awards.

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