Preparation underway for Phase 3 trial of AeroVanc for MRSA lung infection in people with cystic fibrosis
Austin, TX – March 1, 2016 – Savara Pharmaceuticals announced today that it has closed a $20 million Series C financing round. Preparations are underway to begin a pivotal Phase 3 clinical trial of AeroVanc, the first inhaled antibiotic being developed to address the growing problem of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in people with cystic fibrosis (CF).
"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," said Rob Neville, Chief Executive Officer of Savara Pharmaceuticals. "Research shows that people with CF 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 CF."
Savara is currently in the process of selecting research sites for its upcoming Phase 3 study, with approximately 80 U.S. and Canadian sites expected to participate. Study enrollment is expected to start in Q4 2016.
AeroVanc is currently being developed as a treatment for persistent MRSA lung infection in people with CF. By delivering vancomycin directly to the lungs, higher vancomycin concentrations are achieved at the site of infection, which is expected to lead to improved clinical efficacy. In addition, direct delivery of the drug into the lungs reduces exposure to the drug elsewhere in the body, and is thereby expected to reduce the risk of systemic drug-related side effects. AeroVanc has received from the FDA Fast Track and Orphan Drug designations as well as Qualified Infectious Disease Product (QIDP) status providing a total of 12 years of market exclusivity.
About Cystic Fibrosis
Cystic fibrosis is a life-shortening genetic disease characterized by thick, sticky mucus in the lungs and frequent lung infections, which result in loss of lung function. As the disease progresses, the lungs of people with CF are typically infected with bacteria that are difficult to eradicate. Physicians have been using nebulized antibiotics to treat these infections and have sought new options for treatment in the chronic care setting. Infection by MRSA has become increasingly common with a prevalence of almost 30 percent of the estimated 32,000 people with CF in the U.S. Persistent MRSA infection is associated with faster decline in lung function, increased hospitalizations and reduced survival. Currently there is no approved inhaled therapy for MRSA infection in people with CF.
About Savara Pharmaceuticals
Savara Pharmaceuticals is a specialty pharmaceutical company focusing on innovative drugs for the treatment of serious and life-threatening rare respiratory diseases. The company's lead product, AeroVanc, is the first dry powder inhaled antibiotic being developed for the treatment of MRSA infection in people with cystic fibrosis. For more information, please see Savara's website at www.savarapharma.com, or www.aerovanc.com, or find us on Twitter, Facebook and Linke