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A Novel Probiotic Platform to Treat Necrotizing Enterocolitis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41GM122130-01A1
Agency Tracking Number: R41GM122130
Amount: $331,395.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 300
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-08-01
Award End Date (Contract End Date): 2019-04-30
Small Business Information
Fishers, IN 46037-9152
United States
DUNS: 079865175
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (614) 722-3900
Business Contact
Phone: (765) 376-1471
Research Institution
700 Children's Drive
COLUMBUS, OH 43205-2664
United States

 Domestic Nonprofit Research Organization

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 Childrenandapos 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 of
infants born under g will develop the disease and mortality for affected infants is 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 $ million to $ 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 Produce a functional scalable stable prototype of the ProNext Probiotic platform
ProTect that can be productized Aim Determine the efficacy of ProTect compared to the current probiotic
formulation for protection of the intestines from NEC Aim 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 PROJECT NARRATIVE
In this project Monon Bioventures and its research partners at Research Institute of Nationwide Childrenandapos s
Hospital will develop a novel delivery system that will maximize the effectiveness of administration of probiotics
health promoting bacteria The clinical indication is necrotizing enterocolitis NEC a disease that affects
premature babies and has a mortality rate of up to

* Information listed above is at the time of submission. *

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