Since N-Chlorotaurine (NCT) has recently demonstrated rapid virucidal activity in vitro against SARS-CoV-2 and other acute respiratory infections, Pathogenics is currently focused on conducting clinical studies that demonstrate in vivo the safety, tolerability and efficacy of inhaled NCT as a novel antiviral/anti-inflammatory medication for the prophylaxis and treatment of COVID-19 in mild-to-severe cases and other infections.
All the clinical trials conducted to date on NCT were conducted according to Good Clinical Practice (“GCP”) guidelines. GCP guidelines are internationally accepted (including the USA) ethical and scientific quality standards for designing, conducting, recording, monitoring, auditing, recording, analyzing and reporting clinical trials that involve the participation of human subjects. Compliance with these standards provides public assurance that the rights, safety, and well-being of trial subjects are protected, and that the clinical trial data are credible.
Safety and Tolerability
Researchers have completed several clinical trials testing the safety, tolerance and efficacy of NCT as an agent for the treatment of infections. The clinical trials conducted by the researchers to date have proved NCT tolerability on the skin and mucous membranes and have demonstrated efficacy in several conditions including infected leg ulcers, eye infections, inflammation of the sinuses caused by infections and bronchopulmonary infections.
The safety and tolerability of repeatedly inhaled NCT in humans was recently confirmed in a placebo-controlled phase I clinical study. Only minor and transient adverse effects were found, i.e. chlorine taste and occasional tickle in the throat. NCT is not distributed systemically, which explains the absence of systemic adverse effects.
The efficacy of N-Chlorotaurine (NCT) has already been established in several Phase II clinical pilot studies in Europe, including sinusitis, viral conjunctivitis, otitis externa and crural ulcers. These studies suggest that NCT should continue demonstrate further efficacy in a broad range of various topical and body cavity indications.