There are three phases in a clinical trial:
- Phase 1 determines safety in a small patient population
- Phase 2 looks for potential adverse affects and early activity in about 100 patients
- Phase 3 determines side effects and efficacy in a substantial patient population
Studies can be run in multiple countries in parallel and can be used to a) collectively to get approval here in the US and b) separately get approval in those respective countries. As you may recall, we did not encounter any adverse side effects during Phase 1 in Australia. We are currently in Phase 2 in several sites in Canada for WST-057 in patients with diabetic peripheral neuropathy. These sites are run by several of the leading research clinicians in the field who all are considered top key opinion leaders in the field of diabetic peripheral neuropathy.
We also met with the US FDA in September 2019 to initiate Phase 2 trials in the US. It was a very positive interaction; the FDA asked for additional safety tests in animals and provided significant guidance for our Phase 3 in the US. Our active drug for WST-057 is a drug that was approved and used by millions of people for gastric ulcers. However, it was never approved in the US and is thus considered a new drug, in any format. This was made clear by the US FDA–no shortcuts. However, they did acknowledge that WST-057 is eligible for certain expedited review programs.
This said, the active drug in WST-057 was approved in other countries. We are looking to exploit this. With strong evidence to suggest positive results, we believe we can start and complete trials in other countries (e.g. China and Canada) much earlier than in the US. Each country has its own version of the FDA. We are planning meetings with these agencies in mid-2020 and if all goes well, we hopefully can start our Phase 3 trials (an international, multi-center trial) beginning in these countries by 2020. With over 50 million affected with various forms of peripheral neuropathy in China alone, these outside markets could indicate a quicker path to approval and sales.
In addition, we are looking to expand trials in other indications in 2020, including chemo-induced peripheral neuropathy and HIV-induced peripheral neuropathy. We have been approached by the leading institutes to run these trials, and quietly, we are building a reputation amongst the academic community. WinSanTor is clearly looking to differentiate itself by striving to develop drugs that impact patients’ lives.