A Novel Probiotic Platform to Treat Necrotizing Enterocolitis

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PROJECT SUMMARY Probiotics hold enormous potential for promoting human health and treating disease. One major hurdle to many probiotic products is their lack of persistence in the gut. Monon Bioventures (MBV) and their research partners at the Research Institute at Nationwide Children's Hospital (RINCH) are developing a novel, enhanced, tunable technology called ProNextTM, that allows for a persistent probiotic benefit from just a single dose. The combination of ProNextTM and the probiotic Lactobacillus reuteri will create the first commercial- grade probiotic platform product “ProTect”. This STTR proposal focuses on the development of ProTect as the first single dose treatment that protects premature infants from necrotizing enterocolitis (NEC). 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, and treatment and preventive approaches for NEC remain suboptimal. NEC is still 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. Novel approaches for the treatment of patients with NEC are critically needed. In Phase I of this STTR, MBV and RINCH will accomplish three specific aims necessary to move towards commercialization: Aim (1) Produce a functional, scalable, stable prototype of the ProNext™ Probiotic platform (ProTect) that can be productized; Aim (2) Determine the efficacy of ProTect compared to the current probiotic formulation for protection of the intestines from NEC. Aim (3) Determine the optimal dose and establish the initial safety of ProTect for protection of the intestines from NEC. This Phase I STTR project will allow MBV and RINCH to collect the pivotal data needed to scale up to a large animal model in Phase II, and to license the technology to a commercial partner in Phase III for commercialization. The product proposed here will be the first effective solution to this unmet clinical need.