NORS2791 product candidate is a topical formulation of NORSTM developed for the treatment of onychomycosis, a fungal infection of the nail. In patients diagnosed with this infection, NORSTM will be delivered via a specially-designed bandage containing a NO releasing gel.
Onychomycosis begins in the nail bed and progresses to the nail plate, causing the nail to become discolored, deformed, and eventually separated from the nail bed. Pain, discomfort, and disfigurement may precipitate serious physical and occupational limitations for the patient. The fungus Trichophyton (T.) rubrum is the most common dermatophyte involved in onychomycosis. Toenails or fingernails may be affected but the disorder is more commonly seen in toenails.
NORSTM has been shown to be highly effective in eradicating T. rubrum both in-vitro and in a human proof-of-concept trial. Additionally, it is expected to act as an anti-inflammatory, reducing associated symptoms throughout treatment.
The US onychomycosis therapeutics market is steadily expanding, and a high demand for treatment alternatives is anticipated given that an estimated 35 million Americans currently develop the infection each year. The market is expected to reach $5 billion by 2021, and some generic topical agents have achieved $125 million in peak US sales.
SaNOtize is currently designing a phase II clinical trial to evaluate the safety and efficacy of nitric oxide releasing gel (NORGTM) to treat onychomycosis.