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

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.

Joana is currently completing her PhD in Biomedicine and Clinical Research at Universidade de Lisboa. She also holds a BSc in Biology and an MSc in Evolutionary and Developmental Biology from Universidade de Lisboa. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that make up the lining of blood vessels — found in the umbilical cord of newborns.
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Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Técnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.
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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Joana is currently completing her PhD in Biomedicine and Clinical Research at Universidade de Lisboa. She also holds a BSc in Biology and an MSc in Evolutionary and Developmental Biology from Universidade de Lisboa. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that make up the lining of blood vessels — found in the umbilical cord of newborns.
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4 comments

  1. May Mya Win says:

    N115 is a breakthrough for patients with Idiopathic pulmonary fibrosis as it brings great improvement in lung functions.
    This enables a patient to live a reasonably normal life.
    * Relative freedom from infections.
    * Less or no supplemental Oxygen are every patient’s dream.
    It will also definitely prolong life.
    I can’t wait to use it.
    How can I get the medicine?

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