NK is an oral or inhaled drug for both airways disorders and pulmonary disorders

As a mast cell stabilizer, NK has been found to potently inhibit the release of pro-inflammatory cytokines from human white blood cells. The currently available monoclonal antibodies for asthma targets IL-5 or IL-4 + IL-13, all of which are potently inhibited by NK. These cytokines are known to induce pulmonary eosinophil recruitment. Thus, it is not a surprise that NK potently inhibits pulmonary eosinophil accumulation.

Interestingly, the pulmonary concentration of NK is up to 100 times higher than the corresponding plasma concentration after four or more days of once daily oral administration of NK to rats and dogs.

While the adverse immune-suppressant activity of inhaled steroids may contribute to microbial growth in the lungs of asthma and COPD patients, the pulmonary concentrations of NK after inhalation of the drug have been found to express antimicrobial effects against pulmonary fungi, molds and bacteria.

NK is designed for both inhalation and oral use. The drug is rapidly absorbed in humans after oral administration and had long half-life in the plasma (t ½ = 12 hrs) when administered orally to healthy volunteers.

PROOF OF CONCEPT STUDIES (Pulmonary Disorders):
NK is the active and long-acting metabolite of ketotifen that has been used by asthma patients for over 40 years. Millions of doses of ketotifen have been administered to patients suffering from asthma. The manufacturer’s recommended daily dose is 1.0 mg bid and is rarely exceeded. Oral doses of 1.0 mg ketotifen are rapidly absorbed and metabolized and about 0.5 mg NK is formed. Interestingly this very low dose of NK – administered as the prodrug - has been shown to express therapeutic effects in numerous studies, such as for example a one-year post-marketing surveillance study in 8200 patients in the UK.

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