Austin, Texas, based Savara Pharmaceuticals announced Monday that it has closed a $10 million bridge financing round to support development of AeroVanc, the first inhaled antibiotic being developed to address the growing number of often hospital-acquired Methicillin-resistant Staphylococcus (MRSA) lung infections in people with cystic fibrosis (CF) — 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 Previous investors participated in the financing, and new investors include boutique investment funds and family offices.
The company’s lead product, AeroVanc (vancomycin hydrochloride inhalation powder), is the first dry powder inhaled antibiotic being developed for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in people with CF.
Concurrent with the financing, Savara announced it has completed enrollment in its 80-patient randomized, double-blind, placebo-controlled Phase 2 trial of AeroVanc. This study is being carried out at 40 CF centers nationwide and is evaluating the safety and efficacy of either 32 mg or 64 mg doses of AeroVanc inhaled twice daily. The company expects top line results to be available in the first quarter of 2015.
Returning investors helping finance Savara’s AeroVanc research and development include members of the Central Texas Angel Network, North Texas Angel Network, Tech Coast Angels and Keiretsu Forum. New investors include undisclosed boutique investment funds and family offices. To date, Savara has raised $29 million via these sources, plus grants from the NIH and state of Texas.
The convertible debt financing will be used to get Savara to a data read-out from its fully-enrolled Phase 2 trial evaluating AeroVanc for the treatment of MRSA infections in patients with cystic fibrosis, to prepare for subsequent trials, and to potentially expand its pipeline. The data milestone is expected in the first quarter of 2015.
Tackling MRSA Infections in Cystic Fibrosis Patients
MRSA bacteria are resistant to conventional antibiotics, and inhaled antibiotics are becoming the standard treatment for CF patients and other chronic care patients who experience frequent infections with Pseudomonas aeruginosa, a hardy and adaptable gram-negative, nosocomial, aerobic, coccobacillus pathogen infections and the most common lung pathogen afflicting people with CF. However, even though CF patients with chronic MRSA infection have more hospitalizations, faster decline in lung function, and reduced life expectancy, there are currently no approved inhaled drugs licensed to treat MRSA in people with cystic fibrosis, despite the established practice of treating CF patients’ infections directly at the site of infection — the lungs.
Vancomycin is a U.S. Food and Drug Administration (FDA)-approved intravenously administered antibiotic with proven efficacy in the treatment of MRSA infections. AeroVanc is an investigational, proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. 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.
Last December, the FDA designated AeroVanc as a Qualified Infectious Disease Product (QIDP) and granted it Fast Track status pursuant to section 506(a)(1) of the Food and Drug Administration Safety and Innovation Act (FDASIA) in this lead indication, providing access to incentives including priority review and an additional five years of market exclusivity. The product also has an orphan designation, providing a total of 12 years of market exclusivity.
Savara, which hopes to proactively address that deficiency in the CF treatment arsenal, has been working to devise a therapy to treat MRSA and developed the product candidate AeroVanc (vancomycin hydrochloride inhalation powder), a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration for the treatment of persistent MRSA lung infections in CF patients. AeroVanc is the first inhaled antibiotic specifically engineered to address the growing population of MRSA-infected members of the CF community. By delivering vancomycin directly to the infection site in 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.
Last October, Savara announced on the opening day of the 27th annual North American Cystic Fibrosis Conference that it had received a $1.7 million research award from Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit drug discovery and development affiliate of the CF Foundation, to help advance AeroVanc development.
“First and foremost, Savara will use the additional financing to support the continued development of AeroVanc for people with CF who often struggle with persistent MRSA infection,” says Rob Neville, Chief Executive Officer of Savara Pharmaceuticals. “In addition, the financing adds to our resources for corporate development as we look to expand our pipeline to prepare for Savara’s next stage of growth.”
Mr. Neville had previously observed that “An inhaled dry powder form of vancomycin for MRSA infection will be a logical addition to this and other treatment options available for CF patients. “We are further encouraged by the strong interest and support of key opinion leaders, and the feedback that AeroVanc is exactly what the CF care community has been waiting for.”
Mr. Neville also says that $6 million in support that Savara had previously received from the CF Foundation and the National Institutes of Health, “is yet another acknowledgment that AeroVanc addresses an unmet need for people with CF suffering from MRSA infection…. not only provides critical funding to advance the AeroVanc program, but is also a strong endorsement of the quality and promise of our program.”
ClinicalTrials.gov service of the U.S. National Institutes of Health
The U.S. Food and Drug Administration
Cystic Fibrosis Foundation