COVID-19

It is estimated that approximately 30% of individuals who become infected with the coronavirus and have symptoms will sustain long-term lung damage. The emergence of COVID-19 has dramatically reemphasized the important role of respiratory viruses as causes of severe pneumonia and lung damage. Estimates are that it will take three months to a year or more for a person's lung function to return to pre-COVID-19 levels, if they ever do return to those levels.

The cells in the lungs which are attacked by the COVID-19 virus are the epithelial cells. These cells line the airs sacs in the lung and are directly responsible for the proper exchange of oxygen and carbon dioxide in the healthy lung. When epithelial cells become damaged either by the virus directly, or through a hyper-response by the body's immune system, pneumonia and respiratory distress result. If the epithelial cells can not be regenerated, long-term lung damage and breathing difficulties persist.

Inhaled growth factor therapy than can specifically stimulate the regeneration of epithelial cells in the damage lung has shown clinical promise. Members of the fibroblast growth fact family, including FGF-1, are all potent stimulators of lung epithelial cell proliferation and have shown success in reversing lung damage in animal models of viral pneumonia.

Globally, the third leading cause of death result from respiratory disorders and accounts for approximately 11% of deaths worldwide. A large majority of those dying from respiratory disorders will have lung damage and thus there is a potentially vast pool of candidate respiratory disorders that may be amenable to inhaled FGF-1 treatment.

Based on promising results from prior studies, Zhittya is proposing that a "proof-of-concept" clinical trial be set up, administering inhaled FGF-1 to COVID-19 survivors who still display respiratory deficiencies. This new addition of Zhittya's pipeline of drugs currently in development will receive a high priority.

Additional proof of concept studies can also be initiated in other target patient population with lung damage and respiratory issues. As deaths from respiratory disorders are the third leading cause of death in the world, Zhittya believes this new medical indication for FGF-1 represents a multi-billion dollar market potential.