Savara Pharmaceuticals, an Austin, TX-based startup, said today it has received a $1.7 million research award from Cystic Fibrosis Foundation Therapeutics, a subsidiary of the nonprofit Cystic Fibrosis Foundation.
The award is the latest in a total of $6 million granted to Savara by the cystic fibrosis group and the National Institutes of Health in recent months to help fund phase II clinical trials for its work on a inhaled antibiotic to treat patients with cystic fibrosis. Savara currently has about 20 patients out of 80 enrolled in the study.
The company’s drug, an inhalable powered version of vancomycin (AeroVanc), would be the first inhaled antibiotic to treat people with cystic fibrosis who have a persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection.
“The Cystic Fibrosis Foundation is the most prominent foundation when it comes to overseeing treatment, product development, and treatment regimens,” says Rob Neville, Savara’s co-founder and CEO in an interview. “They are very active foundation, and getting their stamp of approval is tremendously important.”
The award was announced this morning at the opening day of the annual North American Cystic Fibrosis Conference, which is sponsored by the Cystic Fibrosis Foundation. The foundation’s therapeutics arm was founded in 2000 and supports efforts for drug discovery and development. Savara’s study, which is expected to go on through the beginning of the year, is randomly assigning people to a low or high dose of the new drug, or a placebo. The new drug is taken twice a day for 28 days.
The primary objective of the clinical trials is to evaluate the efficacy of the inhaled antibiotic in reducing the numbers of MRSA bacteria in samples of patients’ sputum. The study also aims to assess the drug’s safety and its ability to improve lung function, reduce respiratory symptoms, and prolong the time to pulmonary exacerbations, and reduce the need for other antibiotics.
Savara has so far raised $19 million in angel investment since its founding in 2007. My colleague, Luke Timmerman, who is Xconomy’s national biotech editor, wrote in May about Savara and its work to improve the outlook for patients with cystic fibrosis, a deadly genetic disease.
Cystic fibrosis affects about 30,000 people in the United States. It’s known for causing a buildup of thick, sticky mucus in the lungs that makes it hard to breathe. The mucus also becomes a haven for dangerous infections from bugs like pseudomonas aeruginosa and MRSA.
Current CF drugs such as Novartis’ inhalable tobramycin (TOBI) and Gilead Sciences’ inhalable aztreonam (Cayston) are able to fight pseudomonas. But an inhalable version of vancomycin, the go-to antibiotic for MRSA, has yet to be marketed. Savara believes it has created such a drug and that the rising incidence of MRSA is going to make it a widely prescribed product for CF.
For Neville, the continuing support for Savara’s efforts is significant as it also boosts Texas fledgling pharma startup community. “Texas has a lot of medical device companies but very few pharma companies doing phase 2 trials,” he says.