NORS6491 - for treatment of Athlete's Foot
SaNOtize recently completed a successful Phase I Athlete's Foot study, showing safety and efficacy.
Tinea pedis, known as Athlete's Foot is the most common fungal skin infection in humans and the fungi Trichophyton rubrum and Trichophyton mentagrophytes are the most prevalent fungal species that cause Athlete's Foot. These fungi grow on the surface of the skin and can cause a range of symptoms from itchy mild skin flaking to a painful, angry dry rash with extensive skin cracking. Current standard treatments for Athlete's Foot involve daily application of creams containing azole, allylamine, or ciclopiroxolamine based chemicals for up to six weeks, leading to high rates of non-compliance. Oral drugs can cause systemic side effects and must be taken for two to eight weeks. Despite these treatments, 70% of the time the infection comes back. This is likely due to the inability of these chemicals to destroy resilient fungal spores. Many of those afflicted continue to suffer after multiple courses of treatment and a significant amount of time and money expended.
SaNOtize believes that the disadvantages of current approved products, coupled with weak drug development pipelines of new treatments, create an excellent opportunity for a novel treatment such as NORS. The SaNOtize NORS 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. NORS can not only eradicate fungi and spores but also instantly alleviate symptoms as nitric oxide (NO), the active ingredient, can reduce inflammation. Management believes that this treatment with its superior efficacy, shorter regimen and lower incidence of side effects will allow its NORS foot bath to claim a significant portion of the market.
The SaNOtize team has completed in-vitro trials showing the ability of NORS to eradicate fungi associated with Athlete's Foot. The company have recently completed a successful Phase IIa human clinical study utilizing NORS 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 (NORS) 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.