Savara has received U.S. and Canadian patents for its AeroVanc powdered, inhaled formulation of the antibiotic vancomycin hydrochloride, which combats treatment-resistant lung infections in cystic fibrosis (CF) patients.
The patents from the United States Patent and Trademark Office and the Canadian Intellectual Property Office are good through 2032. Patent applications for AeroVanc are pending in a number of other countries as well.
The U.S. Food and Drug Administration has approved AeroVanc for both Fast Tracking and as an Orphan Drug therapy for MRSA lung infections in CF patients. The FDA has also designated it a Qualified Infectious Disease Product. That means that, in addition to the other protections it has received, Sanara will have an additional five years to market it exclusively.
Savara reported in 2016 that it would conduct a Phase 3 clinical trial of AeroVanc in CF patients. Plans are for it to begin in the third quarter of 2017.
The company said the study will evaluate AeroVanc’s effectiveness, safety, and pharmacokinetics in CF patients with a chronic MRSA lung infection.
Staphylococcus aureus (S. aureus) is one of the earliest harmful bacteria detected in the lungs of infants and children with CF. The rise of the resistant strain in the past 10 years has focused a lot of attention on combatting it.
While MRSA is resistant to several antibiotics, it can be treated with others, and with nose drops and other therapies. AeroVanc was developed as an inhaled formulation of vancomycin, an antibiotic that has been successful against a number of bacterial infections, including MRSA lung infection in CF patients.