Dry powder synthetic surfactant which shows promise for prophylactic treatment of seasonal allergic asthma and other respiratory conditions to get further development
Airpharma and Britannia Pharmaceuticals have signed a global licensing agreement in which Airpharma will develop AP0016, a dry powder formulation of Britannia's synthetic surfactant, Pumactant.
Airpharma will initiate a clinical programme to study the drug's efficacy for seasonal allergic asthma, followed by additional respiratory indications such as perennial allergic asthma and chronic obstructive pulmonary disease (COPD). Airpharma will also assume control of regulatory and marketing initiatives for AP0016 as well as activities related to the eventual commercialisation of the product worldwide, except for the United Kingdom and Ireland, which will remain under Britannia's management.
"We are excited to take the lead in bringing this novel drug to market.
"Some 55 million patients worldwide are treated for asthma, and about half of them suffer attacks triggered by seasonal allergens or other inhaled materials," said Doug Dockhorn, president and chief executive officer of Airpharma.
"Britannia has done excellent work in creating this compound and laying the foundation clinically, and Airpharma will take the next steps through efficacy studies in patients with allergic asthma and other respiratory indications".
The symptoms of asthma have been associated with surfactant dysfunction, and it is known that endogenous surfactant has protective functions.
AP0016 is a protein-free synthetic surfactant made from the naturally occurring phospholipids, Dipalmitoylphosphatidycholine (DPPC) and Phosphatidylglycerol (PG).
When inhaled by patients, the AP0016 powder enhances the body's surfactant system, helping to protect the lungs from inhaled allergens, dust particulates and other environmental insults.
Unlike other surfactant products in development, because AP0016 is made without proteins, it can be inhaled by patients without risk of infection or allergic reaction.
"This compound is a wonderful and unique therapy that has shown great potential in the treatment of respiratory conditions," said Max Noble, managing director of Britannia. "Airpharma is the ideal company to develop this drug. "The company's commitment to and expertise in respiratory disease is tremendous, and we look forward to working with the airPharma team to bring this new treatment to millions of asthma sufferers worldwide".
A Phase II clinical trial conducted by Joy Conway and Professor Stephen Holgate at the University of Southampton School of Medicine showed that all asthma patients who received AP0016 before exposure to inhaled allergens were able to completely eliminate early asthmatic responses, characterised by shortness of breath caused by bronchial constriction.
The drug's effect on late asthmatic responses, which occur three to ten hours after exposure to the allergens, was less dramatic, but still promising.
All subjects treated with AP0016 experienced no significant side effects, it is reported.
