Pharmaxis (PXSL), an Australian biotech focusing on respiratory and autoimmune diseases, said the SFDA accepted for review its application for a clinical trial of Bronchitol, a treatment for bronchiectasis. The clinical goal of Bronchitol is to help patients clear mucus from their lungs by promoting salt and water movement through airway cells. Bronchitol is administered twice daily by inhalation.
Bronchitol has completed a Phase III trial in Australia, where it improved mucus clearance and quality of life. The drug is currently in the middle of a 12-month extension of the Australian Phase III trial to test long-term safety. Pharmaxis expects to complete this trial in mid-year and apply for marketing approval in Australia in Q3.
According to Pharmaxis, people in China have a high incidence of bronchiectasis – the number of people in China with the disease is more than double that of the rest of the world. Bronchitol would be the first new medication for the condition in 20 years.
Pharmaxis noted that it is less expensive to run clinical trials in China than in the rest of the world, and that the data from China trials can be used to support marketing applications elsewhere.
A representative office in Shanghai for Pharmaxis was formally registered and approved earlier this week by the State Administration for Industry and Commerce of the People's Republic of China.
Pharmaxis also expects Bronchitol to be effective against chronic obstructive pulmonary disease and cystic fibrosis.