NicOx S.A. announced positive Phase I/II clinical results for the first administration into man of inhaled NCX 950. NCX 950 is the first in a series of inhaled nitric oxide-donating drug candidates. It is a patented nitric oxide-donating salbutamol salt in development to treat respiratory diseases. Salbutamol (albuterol) is a beta 2-agonist used in treatment of acute episodes of asthma, inducing bronchial dilation through its activity on receptors in the bronchial tissues.

Preliminary data from animal models have shown that NCX 950 is a better bronchial dilating agent than salbutamol. NCX 950 also showed anti-inflammatory activity, which is absent in the beta 2-agonist class. NCX 950 is the first compound using a patented nitric oxide-donating salt approach, supplementing NicOx's nitric oxide-donating derivatives already in clinical development.

The Phase I/II clinical study in an established model of bronchoconstriction in healthy volunteers was designed to compare general safety and tolerability of NCX 950 and its effects versus salbutamol sulphate and placebo on pulmonary function. In total, 24 (non-smoking) healthy subjects were included in the single dose study.

Results showed excellent safety and tolerability for NCX 950. They also demonstrated equipotency for NCX 950 in terms of bronchodilation and a faster onset of action compared to the reference beta-agonist. These first human data confirm the pharmacological profile already seen in animal models. Future clinical studies will be aimed at confirming the anti-inflammatory activity of NCX 950 in addition to bronchodilation.