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
11227 KNIGHTSBRIDGE LN, Fishers, IN, 46037-9152
DUNS: 079865175
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (614) 722-3900
Business Contact
Phone: (765) 376-1471
Email: joe@mononbioventures.com
Research Institution
 700 Children's Drive
COLUMBUS, OH, 43205-2664
 Domestic nonprofit research organization
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 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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