Savara Pharmaceuticals has raised $10 million in a bridge loan to further evaluate its drug candidate for cystic fibrosis.
The therapy, called AeroVanc, is designed to be the first inhaled antibiotic to address methicillin-resistant Staphylococcus aureus, or MRSA, lung infections in people with CF. The drug is currently in a double-blind, placebo-controlled Phase 2 clinical trial with 80 patients. The study is being held at 40 cystic fibrosis centers nationwide and is evaluating the safety and efficacy of either 32 milligram or 64 milligram doses of AeroVanc inhaled twice daily. The company expects top line results to be available in January 2015.
Investors in this latest round of funding include Tech Coast Angels, Keiretsu Forum, the Central Texas Angel Network, and the North Texas Angel Network. In total, Savara has raised $29 million, including a grant from the Texas Emerging Technology Fund. The company, which was founded in 2007, has also received grants from the National Institutes of Health and the Cystic Fibrosis Foundation.
Rob Neville, Savara’s co-founder and CEO, says the funding is a significant milestone, especially considering the company has yet to tap into venture capital. “Raising $29 million from non-institutional investors is, by all regards, a record,” he says.
CF is a genetic condition that causes the buildup of thick, sticky mucus in the lungs, making it hard to breathe. That sticky mucus is also fertile ground for bugs like MRSA and pseudmonas aeruginosa, which can cause dangerous infections. The disease affects about 32,000 people in the United States.
Current standard therapy includes inhalable antibiotics that patients can take at home in order to kill the disease-causing bugs inside their lungs. But Neville says that treatments like tobramycin (TOBI,) from Novartis, or aztreonam (Cayston), from Gilead Sciences, could only fight pseudomonas. He wanted to create an inhalable version of vancomycin, which is the intravenous antibiotic prescribed for those with MRSA. (Inhalable antibiotics are preferable because it delivers the drug more effectively to the lungs and also is easy for patients to administer themselves ad home.)
The focus on pseudomonas made sense since about 60 percent of CF patients have that bug. (Fewer than 30 percent of CF sufferers had the MRSA infection.) Still, a 2010 Journal of the American Medical Association paper looked at patients in the Cystic Fibrosis Foundation’s database and reported that those with MRSA infections had a significantly higher risk of death than those without.
In December 2010, the U.S. Food and Drug Administration designated AeroVanc as a Qualified Infectious Disease Product (QIDP) and granted it fast track status. The drug candidate also received an orphan designation by the regulatory body.
“The combination of the QIDP and fast track status gives us 12 years of market exclusivity,” Neville says. “That makes (AeroVanc) quite attractive.”
