Austin, Texas-based Savara Pharmaceuticals, a company focused on novel drugs for the treatment of rare respiratory diseases, recently announced the completion of a $20 million Series C round of financing. The company is now preparing a pivotal Phase 3 clinical trial on AeroVanc, the first dry powder-inhaled antibiotic under development for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in people suffering from cystic fibrosis.
“The new financing will help support the AeroVanc Phase 3 trial, and expanding our pipeline with other new drugs for serious and life-shortening rare respiratory diseases,” Savara CEO Rob Neville said in a press release. “Research shows that people with cystic fibrosis have a more rapid decline in lung function when infected with MRSA, as well as a reduction in overall survival. Our efforts will hopefully result in the FDA approval of the first inhaled antibiotic for use in MRSA infected people with cystic fibrosis.”
Cystic fibrosis is a severe genetic disease characterized by the formation of thick, sticky mucus in the lungs and recurrent lung infections, impairing lung function. As the disease progresses, cystic fibrosis patients’ lungs are typically infected with hard-to-eliminate bacteria. Physicians have used nebulized antibiotics for the treatment of these infections for some time, and are now seeking more innovative treatment options in a chronic care context.
MRSA infections have become increasingly frequent, and are seen in more than 30 percent of the estimated 32,000 cystic fibrosis patients in the U.S. alone. Persistent MRSA infection is usually linked to a faster decline in lung condition, more hospitalizations and reduced survival rates. There are no current approved inhaled therapies for MRSA in cystic fibrosis patients.
AeroVanc is under development for the treatment of persistent MRSA lung infections by delivering the antibiotic vancomycin directly to the lungs. Higher vancomycin levels at the site of infection are expected to improve clinical efficacy, and direct delivery of the drug into the lungs of patients reduces exposure to the drug in other parts of the body. As a result, AeroVanc is expected to reduce the risk of systemic drug-induced side effects.
AeroVanc has been granted FDA Fast Track and Orphan drug designations, as well as Qualified Infectious Disease Product (QIDP) status, which gives Savara a total of 12 years of market exclusivity.
The company is now in the process of identifying potential research sites for its Phase 3 study. Savara expects to have about 80 American and Canadian sites participating, and study enrollment is scheduled for the fourth quarter of 2016.