SaNOtize recently completed a successful Phase I Athlete’s Foot study, demonstrating treatment safety and efficacy.
Tinea pedis, known as “athlete’s foot”, is the most common fungal skin infection in humans. The fungi, Trichophyton rubrum and Trichophyton mentagrophytes, are the most prevalent fungal species that cause the infection. These fungi grow on the surface of the skin and can cause a range of symptoms, from itchiness and mild skin flaking, to a painful, dry rash with extensive skin cracking. Current treatments for athlete’s foot involve daily application of creams containing -azole, allylamine, or ciclopirox olamine based chemicals for up to six weeks, leading to high rates of non-compliance. Oral drugs are associated with systemic side effects and must be taken over the course of two to eight weeks. Despite these treatments, there is an average 70% return of infection rate. This is likely due to the inability of the above chemicals to destroy resilient fungal spores. Many of those afflicted continue to suffer symptoms after multiple courses of treatment and many dollars spent.
SaNOtize believes that the disadvantages of current approved products, coupled with weak drug development pipelines for new treatments, create an excellent opportunity for a novel athlete’s foot treatment such as NORSTM. The SaNOtize NORSTM treatment includes a 30 minute foot bath, for 3 consecutive days. Human clinical study results to date indicate that this treatment will be more effective than existing options. NORSTM not only eradicates fungi and spores, but can instantly alleviate symptoms due to the anti-inflammatory effect of NO. SaNOtize believes that the superior efficacy, shorter treatment course, and lower incidence of side effects will allow the NORS foot bath to claim a significant portion of the market.
The SaNOtize team has completed in-vitro studies showing the ability of NORSTM to eradicate common fungi associated with athlete’s foot. The company has recently completed a successful Phase IIa human clinical study utilizing NORSTM to treat athlete’s foot. The study was under regulatory auspices and received a “No Objection Letter” from Health Canada. The study was entitled, “A blinded placebo controlled clinical trial to evaluate fungicidal activity with the topical application of nitric oxide releasing solution (NORSTM) in subjects with moderate to severe tinea pedis (Athlete’s Foot)”. The study showed safety and a strong efficacy signal with no treatment related adverse events. This data is being used to design larger multi-center trials.