EmphyCorp’s N115 Completes Phase 3 Trial for FDA Marketing Application in PF Patients

N115, EmphyCorp‘s investigational non-steroidal nasal spray for the treatment of interstitial lung diseases (ILDs), has completed a Phase 3 clinical trial requested by the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) in patients with pulmonary fibrosis (PF).

EmphyCorp’s proprietary non-steroidal nasal spray had previously received orphan drug designation from the FDA for the treatment of ILDs, including PF and cystic fibrosis (CF).

Key findings from the Phase 3 trial, together with data from previous clinical trials assessing the effects of N115 in patients with other ILDs, showed that:

• Measures of lung function, including forced expiratory volume in one second (FEV-1), forced vital capacity (FVC), oxygen levels, and nitric oxide levels (a gas that induces the relaxation and widening of lung airways) all significantly improved in patients with idiopathic pulmonary fibrosis (IPF) treated with N115 in combination with their routine medications (steroids).
• The FEV1/FVC ratio (the proportion of the total amount of air a patient is able to exhale after taking a deep breath in one second) of IPF patients increased from an initial 52% to 86% after treatment with N115.
• In patients with IPF, PF, and chronic obstructive pulmonary disease (COPD), treatment with N115 reduced coughing, nasal irritation/redness, inflammation, and congestion; most patients stopped experiencing irritation within 22 days.
• When IPF patients stopped taking their routine medications and only received N115, they had the same kind of improvements in lung function measures, suggesting that N115 is the main driver of clinical improvements, and that the use of steroids may potentially be reduced.

“The most important conclusion we see from this Phase 3 clinical trial is that our non-steroidal nasal spray for pulmonary fibrosis with no known side effects has greatly improved patient quality of life by allowing these patients to breathe through the nose, sleep better, reduce inflammation and congestion, increase nitric oxide for improved bronchial dilation and help prevent infections, improve vital breathing ratios, reduce coughing, increase oxygen levels from below normal to normal,” Alain Martin, PhD, CEO of EmphyCorp, said in a press release.

“We are not surprised at the results, since our patented non-steroidal nasal spray has been used by over 2 million patients in Chinese hospitals over the past 3 years that includes ‘unmet needs’ patients (children, pregnant women, diabetics, hypertensive), and others with chronic breathing conditions,” Martin added.

N115 is part of the company’s global patented Rx technology, which also includes nasal non-steroidal sprays for COPD, Alzheimer’s disease, cancer pre-treatment, and an oral non-steroidal spray for quitting smoking.

EmphyCorp holds the global rights to its patented Rx technology, and is currently pushing its proprietary non-steroidal Rx technology with no known side effects into the market of chronic lung diseases.

“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,” said Robert Millar, president and director of EmphyCorp. 

The company is planning to enter into sub-license agreements and/or joint ventures with drug manufacturers and other pharmaceutical companies operating in the market of respiratory diseases in the U.S. and other countries to expand its market reach.