EmphyCorp Inc stated on Thursday that it has completed the clinical trial to define medical endpoints as requested by the US Food and Drug Administration (FDA) for its NDA marketing application in patients with pulmonary fibrosis.

The trials with EmphyCorp's Non-Steroidal Nasal Spray demonstrated a statistically and clinically significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (52% to 86%), and nitric oxide (needed to increase bronchial dilation and fight infections) in patients with idiopathic pulmonary fibrosis.

In all patients with idiopathic pulmonary fibrosis and in all patients with pulmonary fibrosis and COPD, inhalation of the nasal spray demonstrated a significant reduction of coughing and a significant improvement in nasal irritation/erythema, inflammation and congestion, with most patients free of irritation by day 22.

Test results were compared to patients' previous three-week screening and baseline data (their current therapies) as the placebo control for each variable including all their lung functions, FEV-1, FVC, PEF, FEV-1/FVC ratios, SaO2, nitric oxide, coughing rates and nasal inflammation. The statistically and clinically significant increase FEV-1, SaO2, PEF, FVC, especially the improved FEV1/FVC ratio from 52% to 86%, was clinically significant since these patients remained on their current therapies (steroids) while using the non-steroidal nasal spray, demonstrating that current therapies in use are inadequate to treat patient with idiopathic pulmonary fibrosis, EmphyCorp said.

When patients were removed from their medication and only used the nasal spray, the Non-Steroidal Nasal Spray demonstrated a statistically and clinically significant increase in all lung functions including FEV-1, SaO2, PEF, FVC and nitric oxide. This indicates that the nasal spray can reduce the need for inhaled steroids.