NORS4002 is a product candidate in development as a nasal lavage for the treatment of sinusitis, which is also called rhinosinusitis. The condition is an inflammation of the sinuses that causes a range of symptoms including plugged nose, thick nasal mucosa, facial pain, fever and headaches. Infectious causes of sinusitis can be bacterial, viral or fungal. Typical causative microbes include rhinovirus, coronavirus, influenza viruses and adenoviruses, as well as Streptococcus pneumoniae and Haemophilus influenzae. Chronic sinusitis affects 12% of the American population under 45 years of age.
Current treatment options include antimicrobials, corticosteroids, decongestants, antihistamines, mast cell stabilizers, antileukotrienes, nasal douching, immunotherapy and avoidance of specific environmental factors. Functional endoscopic sinus surgery is performed when sinusitis is refractory to conventional non-surgical therapies, with 1-to-3 year follow-up results showing that the procedure alleviates symptoms in roughly 75% of patients.
The SaNOtize team believes that NORSTM may be especially effective as a nasal lavage for treating sinusitis, regardless of infectious etiology. In vitro studies have demonstrated the efficacy of NO and NO delivered through NORSTM against many strains of bacteria, viruses and fungi associated with sinusitis.
Phase 1 dose escalation trial was completed and phase II (N=54) was initiated in Dec 2019. Expected completion – first quarter 2021.