SaNOtize completed a successful pilot phase II study demonstrating the safety and efficacy of its footbath treatment NORS6491 for athlete’s foot.
Athlete’s foot, or tinea pedis, is the most common fungal skin infection in humans. Trichophyton(T.) rubrum and (T.) mentagrophyte, which are the most prevalent fungal species that cause the infection, grow on the surface of the skin and can cause symptoms ranging 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 for two to eight weeks. The average rate of re-infection with existing treatments is 70%. which is likely due to their inability to destroy resilient fungal spores. Patients often report ongoing symptoms after multiple courses of treatment which can be extremely costly.
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 NORS. The SaNOtize NORS treatment includes a 30-minute foot bath for three consecutive days. Clinical study results to date indicate that this treatment is more effective than existing options as NORS not only eradicates fungi and spores but also provides prompt resolution of symptoms due to NO’s anti-inflammatory effect. SaNOtize believes that superior efficacy, a shorter treatment course, and a 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 NORS to eradicate common fungi associated with athlete’s foot. The company completed a successful pilot phase II study that evaluated fungicidal activity with the topical application of nitric oxide releasing solution (NORS) in patients with moderate to severe athlete’s foot. The study, which received a “No Objection Letter” from Health Canada. showed safety and a strong efficacy signal with no treatment-related adverse events. The data are being used to design larger multi-center trials.