1. Phase 2 clinical trial testing safety and efficacy of topical pirenzepine to treat diabetic neuropathy
Paul Fernyhough
Division of Neurodegenerative Disorders, St. Boniface Hospital Albrechtsen Research Centre and Deptartment of Pharmacology & Therapeutics, University of Manitoba, Winnipeg, Manitoba, Canada

2. Objective
Test safety and efficacy of novel topical therapeutic for diabetic sensory neuropathy
Preclinical studies reveal antimuscarinic drugs, including pirenzepine, prevent/reverse diabetic neuropathy
Proof-of-concept study with oxybutynin showed efficacy in persons with type 2 diabetes
Data from Nigel Calcutt, UCSD, and Arthur Vinik, EVMS

3. Phase 2 clinical trial Outcome
Performed by Drs. Vera Bril and Bruce Perkins at UofToronto/UHN
In collaboration with WinSanTor Inc
N=40-60 persons with type 2 diabetes and mild/moderate neuropathy
Topical application of pirenzepine in novel formulation
Primary endpoint is intraepidermal nerve fiber (IENF) density in lower limb
Secondary endpoints include sensory testing, neuropathy scale and quality of life (QOL) assessments
Outcome
This data combined with data from other sites will permit initiation of phase 3 trial by 2021