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Savara Completes Phase I Clinical Study of AeroVanc in Cystic Fibrosis Patients


6/12/2012 11:08:31 AM

AUSTIN, Texas, June 12, 2012 /PRNewswire/ -- Savara Pharmaceuticals, an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions, today announced positive top-line data from its AeroVanc Phase I clinical study in patients with cystic fibrosis (CF).

AeroVanc, a dry powder formulation of vancomycin, is the first inhaled antibiotic being developed for the treatment of respiratory methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with CF. The dose-escalating Phase I clinical study examined the tolerability, safety and pharmacokinetics of AeroVanc in non-MRSA infected CF patients. AeroVanc was well tolerated and safe and produced high concentrations of vancomycin in the sputum. In line with the pharmacokinetic results in healthy volunteers, the clearance of vancomycin from the lungs was slow, indicating a favorable profile for once- or twice-daily dosing.

"Persistent MRSA lung infection in CF patients has been associated with faster decline of lung function and significantly shortened survival. Whereas inhaled antibiotics have become a cornerstone of treatment of Pseudomonas infections in CF, there are currently no approved inhaled drugs available to treat MRSA lung infection," said Elliott C Dasenbrook, Associate Director of the Adult Cystic Fibrosis Program at Case Western University. "Pulmonary delivery of vancomycin is a very promising treatment concept to ensure high drug concentrations at the site of infection, while minimizing systemic toxicity and treatment burden."

"In this trial we have demonstrated sputum concentrations of vancomycin known to effectively kill MRSA, and we therefore have high confidence in being able to suppress or even eradicate the infection with AeroVanc in our Phase IIa study in MRSA-infected patients," said Robert Neville, Chief Executive Officer, Savara.

Savara also recently announced a successful Series B fundraising of $8.6 million. Proceeds from the financing will support AeroVanc's advancement through the Phase IIa clinical study, scheduled to start early next year.

About AeroVanc

AeroVanc (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. Vancomycin administered by IV is the antibiotic of choice for the treatment of MRSA-related bronchopneumonia, however, IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting. AeroVanc is the first inhaled antibiotic being developed for the treatment of MRSA infection in cystic fibrosis patients. By delivering vancomycin directly to the site of infection, AeroVanc is expected to improve clinical efficacy and reduce adverse effects due to systemic drug exposure.

AeroVanc has demonstrated positive safety and tolerability results in a Phase I clinical study conducted in healthy subjects and patients with cystic fibrosis, with a pharmacokinetic profile that supports its potential as a once- or twice-daily treatment for pulmonary MRSA infections.

About Cystic Fibrosis and MRSA

Cystic fibrosis is a genetic disease characterized by the prevalence of thick, sticky mucus produced in the lung, frequent lung infections and a resultant decline in pulmonary function. As the disease progresses, patients' lungs are typically colonized with bacteria that are difficult to eradicate. Such infections are typically treated with inhaled antibiotics, which have become one of the cornerstones in the treatment of cystic fibrosis over the last decade. In recent years, infection and colonization by MRSA has become increasingly common, with a prevalence of almost 30 percent of all cystic fibrosis patients in the United States. Persistent MRSA infection has been found to cause a faster decline in lung function and to be associated with a significantly shortened life expectancy. Currently there is no approved inhaled treatment for MRSA infection in cystic fibrosis patients.

About Savara Pharmaceuticals

Savara Pharmaceuticals is an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions. The company's lead product, AeroVanc (vancomycin hydrochloride inhalation powder), is the first dry powder inhaled antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis.

SOURCE Savara Pharmaceuticals



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