EmphyCorp has been granted eight U.S. patents and three additional are pending with respect to its new drug, "N115". Until now the primary treatment for asthmatic bronchitis and chronic obstructive pulmonary diseases is the use of corticosteroids (67%). It is well documented that prolonged use of corticosteroids for the treatment of pulmonary diseases has serious side effects including death. Other marketed drugs for the treatment of pulmonary diseases can produce central nervous system, cardiovascular, respiratory and gastrointestinal problems.
Key distinctions of N115 for pulmonary diseases are:
- There is a significant worldwide medical need and market for a safe and effective pulmonary disease therapy that can be effective as both a bronchodilator and an anti-inflammatory agent. EmphyCorp believes that N115 will prove to be a safe and effective duel acting therapy.
- N115 is a natural component of the human body and will have less side-effects than current methods of treatment for asthma and other major respiratory diseases (such as steroids or albuterol). The low side-effect profile should be especially important in children.
- The FDA has granted EmphyCorp Orphan Drug designation for a class of rare (but often fatal) pulmonary diseases known as Interstitial Lung Disease (ILD). EmphyCorp is the only company to have received such a designation by the FDA for this class of diseases. This designation attests to the FDA's recognition of N115 as one of a new class of drugs known as Reactive Oxygen Species (ROS) Antagonists, for the treatment of pulmonary disease.
- The FDA has granted EmphyCorp a second Orphan Drug designation for the use of N115 in the treatment of Cystic Fibrosis a class of pulmonary disease. EmphyCorp is the only company to have received such a designation by the FDA for this class of disease for a small molecule.
- Currently, N115 is the only known dosing method of using sodium pyruvate for respiratory diseases by inhalation into the lung i.e., by a nebulizer. This dosing method is strongly protected in the patents. Other dosing routes like oral administration, topical administration or injection are extremely unlikely to be effective in this application.
- Estimates of the Costs of N115 production and application will make it a cost-effective pulmonary disease treatment on the market.