Our aim is to change the current state of neuropathy in three to five years, by bringing to market a first-in-class, true cure for peripheral neuropathy. WinSanTor’s lead compound, WST-057, shows the ability to prevent nerve damage and re-grow damaged nerves. With its well-known safety profile, WST-057 is on track to an accelerated regulatory approval and to the clinic.
WinSanTor recently completed its Phase 1 study, a multiple dose study with normal healthy volunteers in Australia. No further Phase 1 studies will be conducted. WinSanTor will begin recruiting for its Phase 2 trials in Canada later this year, in Europe early next year and China thereafter. In the United States, where our lead compound is a new drug (aka new chemical entity), additional safety pharmacology and toxicity studies are necessary. These studies are ongoing to enable us to begin efficacy studies in 2019 in the United States. These studies will all be to treat diabetic peripheral neuropathy. Two global Phase 3 studies (scheduled to begin in late 2019/early 2020) and one open label safety study will be conducted for registration.
In parallel, WinSanTor plans to run clinical studies in more distinct populations such as chemotherapy-induced peripheral neuropathy to accelerate approval of our drug in several countries. WinSanTor may possibly conduct trials for other (orphan) indications enabling us to exploit various regulatory acceleration programs available in the US and Europe.