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Pre Clinical Safety and Efficacy of TRB N for the Treatment of Periodontal Disease

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42DE024946-02
Agency Tracking Number: R42DE024946
Amount: $1,320,432.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIDCR
Solicitation Number: PA15-270
Timeline
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-01
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Mailbox 314, Stony Brook, NY, 11790-0314
DUNS: 078868123
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 LORNE GOLUB
 (631) 632-9949
 lorne.golub@notes.cc.sunysb.edu
Business Contact
 JOSEPH SCADUTO
Phone: (631) 258-5680
Email: jscaduto@traversebiosciences.com
Research Institution
 STATE UNIVERSITY NEW YORK STONY BROOK
 STATE UNIVERSITY NEW YORK STONY BROOK
STONY BROOK, NY, 11794-3362
 Nonprofit college or university
Abstract
PROJECT SUMMARY ABSTRACT Traverse Biosciences Inc is a pre clinical stage drug development company working to commercialize new chemical entities which act to resolve inflammatory conditions through pleiotropic host modulation of pathologically unrestrained matrix metalloproteinases MMPs and pro inflammatory cytokines The companyandapos s lead drug candidate TRB N is a proprietary chemically modified curcumin developed by the co inventor of Periostat and Oracea currently the only FDA approved MMP inhibitors Periodontal disease is a chronic inflammatory condition involving interactions between oral bacterial products numerous cell populations in the host tissues and inflammatory mediators such as cytokines chemokines arachidonic acid metabolites and proteolytic enzymes including matrix metalloproteinases which collectively contribute to tissue destruction and bone resorption The Centers for Disease Control CDC estimates that the prevalence of periodontitis in U S adults aged years and older is M and the prevalence of mild moderate and severe periodontitis is M M and M respectively Periodontal disease has also been associated with other chronic conditions such as heart disease diabetes and various cancers Most current drug therapies are primarily focused on the management of the microbial biofilm not taking into account the central role of inflammation in causing tissue damage which makes this therapy only partly effective TRB N exhibits pleiotropic anti inflammatory effects as a broad spectrum MMP modulator as well as an inhibitor of pro inflammatory cytokines such as IL TNF and IL likely through interruption of the NF kB pathway TRB N acts to resolve inflammation via a multi target host modulatory approach that overcomes the challenges of redundancy compensation and necessity exhibited by the immune system Curcumin was chosen as a parent structure because it also has a diketo moiety similar to that of the tetracyclines and chemical modifications were pursued to overcome limited clinical use of curcumin due to its insolubility rapid metabolism and modest biological activity Our long term goal is to develop an effective inhibitor of inducible MMPs with minimal side effects and toxicity that will significantly reduce the complications associated with periodontal disease The objective here which is the next step in the pursuit of our goal is to test the efficacy of our lead compound TRB N in a naturally occurring canine model of periodontal disease Our Phase II Hypothesis is that administration of TRB N will improve clinical assessments including bleeding on probing and attachment loss and protect alveolar bone from MMP damage in a naturally occurring canine model of periodontal disease We anticipate that TRB N will also lower the gingival tissue and serum levels of pro inflammatory mediators Our specific aims are to evaluate the effectiveness of our lead compound TRB N to treat periodontal disease using a naturally occurring canine model Bone loss will be determined radiographically by measuring the distance from a fixed anatomical landmark the cemento enamel junction to the alveolar bone crest and levels activity of MMPs and inflammatory cytokines will also be assessed Successful completion of Phase II will allow us to pursue follow on funding from private sources and or a strategic partner to support pre clinical testing of TRB N in preparation for a Investigational New Drug IND application to the U S Food and Drug Administration FDA We hope to commercialize TRB N as an FDA approved pharmaceutical intervention for the treatment of periodontal disease in an orally administer i e systemic formulation and intend to pursue pre clinical and clinical development to demonstrate the safety and efficacy of this lead drug candidate PUBLIC HEALTH STATEMENT PROJECT NARRATIVE The Centers for Disease Control CDC estimates that the prevalence of periodontitis in U S adults aged years and older is M and the prevalence of mild moderate and severe periodontitis is M M and M respectively Periodontal disease has also been associated with other chronic conditions such as heart disease diabetes and various cancers This proposed project is directly relevant to the public health since it is to develop a promising new drug candidate for the treatment of this critical unmet medical need Moreover the drug candidate has also shown promise in a variety of other disease areas related to chronic inflammation demonstrating the potential for broad application and societal benefit if proven to be both safe and effective

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

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