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Even though the active ingredient in our drug has been used in Asia and Europe, it was never approved in the US in any format, making the drug a new chemical entity (NCE) in the United States. WST-057 has been in development for over ten years. However, it is currently in its last phase of development, Phase 3 in the United States for diabetic peripheral neuropathy, which determines the efficacy of the drug in patients with diabetic peripheral neuropathy.
Our aim is to develop the first disease-modifying treatment for peripheral neuropathy that has the potential to prevent and reverse the nerve damage and the symptoms associated with the disease. Our lead compound, WST-057, shows the ability to prevent nerve damage and regrow damaged nerves.
Phase 1 and Phase 2 are now complete. Topical WST-057 was shown to be safe and tolerable when administered to diabetic peripheral neuropathy patients for up to six months in these studies, but will need to be studied in a larger Phase 3 population (several thousand).
Based on the results of our studies in humans and animals, it appears WST-057 is regenerating peripheral nerves, particularly the axon terminals (intraepidermal nerve fiber (IENF)) which are measured through biopsies of the skin at the beginning and end of studies. These skin biopsies measure IENF density, the number of nerves that transect the dermis-epidermis layer. We are seeing strong IENF regrowth over a six-month period.
We are currently preparing for our Phase 3 trials.
In summer 2019, we met with the US FDA to discuss trials in the United States to treat diabetic peripheral neuropathy. Since this time, our programs have received FastTrack designation giving our team greater access and additional resources from the US FDA. We will meet with the FDA again for our post-Phase 2 meeting in early 2023, with Phase 3 studies in North America to start shortly thereafter. For registration (approval) of our drug in the United States, we will need to run two large Phase 3 pivotal studies—a global study with many sites and multiple clinicians—that test for adverse effects and efficacy. We will seek assistance from the public to help us find suitable sites. This may not be true in other countries, particularly those where the active ingredient was already in use, where only one study may be necessary or where it may be approved conditionally. We are not leaving any stones unturned. In parallel, we are preparing studies in other indications, such as chemo-induced peripheral neuropathy.
