EmphyCorp FDA Submission for Rx New Non-Steroidal Nasal Spray for Pulmonary Fibrosis

EmphyCorp announced the completion of a clinical trial to define medical endpoints as requested by the FDA for the NDA marketing application in patients with Pulmonary Fibrosis, under its Orphan Drug Designations for the treatment of Interstitial Lung Diseases (ILD), which includes Pulmonary Fibrosis and Cystic Fibrosis.

The Clinical trials with our 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, the inhalation of our nasal spray demonstrated a significant reduction of coughing (p=0.007), a significant (p=0.010) improvement in nasal irritation/erythema, inflammation and congestion, with most patients were free of irritation by day 22 (p=0.000).

In all patients, the test results were compared to their 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, 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 our non-steroidal nasal spray, which demonstrated that current therapies in use are inadequate to treat patient with Idiopathic Pulmonary Fibrosis.

When patients were removed from their medication and only used the nasal spray, our 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 would indicate that the nasal spray can reduce the need for inhaled steroids.

"Our goal is to get our portfolio of Non-Steroidal Nasal Sprays into the market as quickly as possible to help provide immediate improvement in "Quality of Life" for millions of Patients suffering from chronic breathing diseases. Of special interest is providing 30 to 60 million "Unmet Needs" Pregnant Women, Children, Diabetic and Hypertensive Patients that should not take Steroids with a totally safe alternative to daily use of Steroid Nasal Sprays and Steroid COPD Sprays." said EmphyCorp President Robert Millar.

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