We’ve been following Savara (NASDAQ: SVRA) for many moons as the company continues to validate its therapeutic pipeline across a range of severe lung disease indications. The company announced today that it received a development award of up to $5 million from Cystic Fibrosis Foundation Therapeutics (CFFT), the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation. The award is available to support the continued development of Savara’s AeroVanc powder, the first inhaled antibiotic being developed for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in individuals living with cystic fibrosis. The CFFT award can be drawn down by Savara as needed upon the achievement of continued progress and certain milestones in its AeroVanc program and ongoing Phase III “AVAIL” study.
According to the Cystic Fibrosis Foundation, MRSA is found in about 26% of people with cystic fibrosis and studies have reported that infections caused by MRSA can become a long-term condition and even affect survival. AeroVanc is a powder form of vancomycin, an antibiotic that has been widely used for more than 60 years to treat various bacterial infections. Vancomycin inhibits bacterial cell wall synthesis, thereby stopping the bacteria from multiplying and spreading. Although vancomycin is an FDA-approved intravenously administered antibiotic with proven efficacy against MRSA infections, poor penetration into the lungs and systemic toxicities limit its use as a chronic treatment. AeroVanc, which is delivered directly to the lungs via a self-administered reloadable capsule-based inhaler, is expected by Savara to improve clinical effectiveness and reduce adverse effects related to broad-spectrum antibiotics.
Source: Savara corporate presentation, November 2017
The AVAIL study is a Phase III, randomized, double-blind, placebo-controlled study that will enroll approximately 200 subjects at more than 80 clinical study sites across the US and Canada. During Period 1 of the study, subjects will be randomly assigned in a blinded 1:1 fashion to receive either AeroVanc (30 mg) twice daily, or placebo, by inhalation for 24 weeks or 3 dosing cycles. A dosing cycle is defined as 28 days of treatment followed by 28 days of observation. During Period 2 of the study, subjects will receive open-label AeroVanc (30 mg) twice daily for an additional 24 weeks or 3 dosing cycles, to evaluate the long-term safety of AeroVanc.
We are delighted to have the CF Foundation’s continued support and we believe this award serves as strong validation of our AeroVanc program. Our AVAIL study was planned in consultation with the CF Foundation’s Therapeutic Development Network as well as key opinion leaders across the country, and we are excited to have the study started and enrolling.
– Rob Neville, CEO of Savara
Cystic fibrosis has been a primary focus of my research interests for many years. Inhaled antibiotics have become the standard of care to treat Pseudomonas aeruginosa lung infection and we are now on the verge of demonstrating that a similar approach should be used for MRSA. AeroVanc has shown potential as a novel treatment for MRSA lung infection, a growing problem not currently addressed by any other available inhaled antibiotics. If the results from the AVAIL study are positive, I believe AeroVanc could become the new standard for inhaled antibiotic treatment of MRSA in CF.
– Patrick Flume, MD, Director, Adult Cystic Fibrosis Center and Professor of Medicine and Pediatrics at the Medical University of South Carolina and coordinating principal investigator of the AVAIL study.
Though the stock has more than doubled since we first highlighted the company four months ago, we believe the risk-reward proposition of Savara continues to merit close attention from investors. We’ll continue to monitor the company’s clinical progress with keen interest.
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