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Regeneration of Epidermal Nerves in Human Diabetic Neuropathy

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DK104512-05
Agency Tracking Number: R44DK104512
Amount: $2,981,077.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 200
Solicitation Number: PAR18-108
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-05-01
Award End Date (Contract End Date): 2022-04-30
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
 ANGELA HANSEN
 (858) 546-9044
 ahansen@winsantor.com
Business Contact
 STANLEY KIM
Phone: (858) 336-8094
Email: skim@winsantorbio.com
Research Institution
N/A
Abstract

Project Summary/Abstract
There is no FDA-approved therapy to prevent or reverse peripheral neuropathy, a condition that afflicts
around 30 million people in the US and is often associated with diabetes, chemotherapy or HIV infection.
Our published preclinical studies have revealed that peripheral nerve metabolism and growth is retrained
under both in vitro and in vivo conditions by cholinergic suppression of mitochondrial activity acting via
neuronal M1 receptors. Removal of this cholinergic “brake” by muscarinic antagonists promotes nerve
growth and protects against neuropathy in multiple animal models of diabetes, chemotherapy and HIV-
induced neuropathy. Proof of concept clinical data obtained via R21 funding demonstrates that topical
treatment with a muscarinic receptor antagonist can significantly reverse loss of intra-epidermal nerve
fibers (IENF) in the skin of patients with diabetic neuropathy and improve multiple indices of neurological
function and quality of life. This exploratory data encourages the present SBIR Phase IIB application. In
Year 1 we will build on our preliminary clinical study by determining the shortest duration of topical
treatment that can produce a statistically significant increase in nerve density in the skin of subjects with
type 2 diabetes and neuropathy. This information will be important for the future design of diverse clinical
studies that seek to assess drug efficacy against small fiber neuropathy and will guide design of our
Phase II studies. In Year 2-3, we will perform a clinical trial to determine the most effective dose of a
topical muscarinic receptor antagonist over the time frame identified in Year 1 and also to establish
whether efficacy is restricted to the site of topical application or extends systemically. The primary end
point for both studies will be skin IENF density at the treatment site. Secondary end points will include
multiple neurological assessment tool scores, quality of life scores, pain scores and IENF density at sites
distant from drug application. We anticipate that successful completion of these studies will position
WinSanTor Inc. to advance a topical muscarinic antagonist formulation towards FDA approval as the first
treatment for diabetic neuropathy.NARRATIVE
Peripheral neuropathy afflicts around 30 million people in the US and there is no FDA-approved treatment. We
will build on preliminary data obtained via R21 funding that demonstrates that topical treatment with a
muscarinic receptor antagonist can reverse loss of nerve fibers in the skin of patients with diabetic neuropathy
and improve multiple indices of neurological function and quality of life. We will define the minimal treatment
duration that can identify nerve regrowth and a Phase II study will use the selected treatment time to define the
optimal dose of a muscarinic antagonist and whether efficacy is local or systemic.

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

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