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Assessment of chronic toxicity to support the use of topical pirenzepine for treating diabetic neuropathy

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2SB1DK104512-04
Agency Tracking Number: SB1DK104512
Amount: $970,226.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 200
Solicitation Number: PAR16-027
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-07-01
Award End Date (Contract End Date): 2018-06-30
Small Business Information
4685 CONVOY ST #210
San Diego, CA 92111-2339
United States
DUNS: 078868444
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (858) 546-9044
Business Contact
Phone: (858) 336-8094
Research Institution

The objective of this SBIR Commercialization Readiness Program CRP project is to evaluate chronic toxicity
of a new therapeutic for diabetic neuropathy in support of an IND submission Of the million Americans who
suffer from diabetes approximately will be diagnosed with neuropathy which is characterized by nerve
degeneration Despite the high prevalence of the disease there is currently no FDA approved treatment to
either prevent diabetes induced nerve degeneration or promote nerve regeneration Thus there is a
substantial unmet need to develop more effective treatments for diabetic neuropathy
The founders of WinSanTor have identified a promising candidate which both prevents and reverses
neuropathy in rodent models of the disease The candidate molecule pirenzepine was identified using a novel
screening methodology developed in the labs of the company s founders Pirenzepine has subsequently been
evaluated in over a dozen in vivo tests and has demonstrated the unique ability to ameliorate both epidermal
fiber loss and thermal hypoalgesia Pirenzepine is an approved drug for other indications in non US countries
and so it is substantially de risked as a drug development candidate In a SBIR Fast track program
WinSanTor successfully executed an expedited pre clinical program that included development and
validation of bioanalytical methods pharmacokinetic analyses optimization of formulation to enhance
delivery generation of a safety profile and GMP manufacturing of pirenzepine These efforts fully support
the continued execution of the pre clinical program through the evaluation of chronic toxicity assessments
The focus of this CRP program will be to evaluate the toxicity of pirenzepine when applied topically for
months A month study was chosen to fulfill the month chronic toxicity study requirement for an NDA
submission and to support the duration of the anticipated Phase clinical trial protocol that will involve
administration for at least months This study will be executed in mini pigs and will use a number of toxicity
end points such as mortality observations clinical observations Draize scoring clinical pathology and
histopathology to fully define a toxicological profile of pirenzepine The metric of success for this Aim is to
achieve to achieve a NOAEL at an exposure level such that there is up to a x safety margin for human
studies The completion of this study is critical to an IND submission to the FDA to support subsequent clinical
There is currently no FDA approved treatment to either prevent diabetes induced nerve degeneration or
promote nerve regeneration and so there is an urgent need for therapies that can provide relief for this painful
and debilitating condition The founders of WinSanTor have identified a known compound pirenzepine which
effectively prevents and reverses nerve degeneration in rodent models of diabetes through a previously
unexplored mechanism of action This project will evaluate chronic toxicity to support pre clinical development
of pirenzepine as a novel therapeutic for diabetic neuropathy

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

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