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Savara's AeroVanc for Cystic Fibrosis Patients Achieves Positive Results in Phase I Clinical Trial

4/26/2012 11:55:48 AM

Austin, TX, April 26, 2012 – Savara Pharmaceuticals, an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions, today announced top-line data from its Phase Ia clinical study of the company’s AeroVanc inhaled antibiotic. AeroVanc (vancomycin hydrochloride inhalation powder) is a novel dry powder form of vancomycin in a capsule- based inhaler for the treatment of respiratory methicillin-resistant Staphylococcus aureus (MRSA) infections in patients with cystic fibrosis (CF).

The dose-escalating Phase Ia clinical trial examined the safety and pharmacokinetics of AeroVanc in healthy volunteers. Single-ascending doses of inhaled AeroVanc were compared to vancomycin administered intravenously. AeroVanc demonstrated a favorable pharmacokinetic profile with slow systemic absorption from the lungs, suggesting prolonged residence of the drug in the lung, the site of anti-MRSA action. AeroVanc was well tolerated at all dose levels, with only infrequent mild adverse events that resolved spontaneously.

“Respiratory MRSA infections are a growing concern for CF patients. Recent published evidence suggests that MRSA accelerates the decline in pulmonary function and shortens the life expectancy of CF patients,” said Bruce C. Marshall, MD, Vice President of Clinical Affairs, Cystic Fibrosis Foundation. “While inhaled antibiotics have been successfully used to control Pseudomonas aeruginosa infections in CF patients, there is no inhaled treatment available for MRSA infections. We are very interested in AeroVanc development, and hopeful AeroVanc will be a new treatment option for respiratory MRSA in CF patients.”

“AeroVanc has demonstrated excellent local tolerability and a favorable pharmacokinetic profile to effectively combat MRSA infections in this Phase I clinical trial,” said Robert Neville, Chief Executive Officer of Savara. “AeroVanc has the potential to make a significant impact on CF patients’ lives as the first approved inhaled treatment for pulmonary MRSA infections.”

Savara has recently completed enrollment for a Phase Ib clinical trial of AeroVanc evaluating tolerability and lung pharmacokinetics in CF patients. Results from this study are anticipated in the first half of 2012.

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 being developed for the treatment of MRSA infections in cystic fibrosis patients. By delivering vancomycin directly to the site of infection, AeroVanc is expected to improve clinical efficacy and reduce systemic exposure.

About MRSA and Cystic Fibrosis

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. In recent years, infections and colonization by MRSA have become increasingly common, with a prevalence of up to 30 percent of all cystic fibrosis patients. MRSA infections have been found to cause a decline in lung function and are associated with a significantly shortened life expectancy. Currently there is no approved inhaled treatment for MRSA infections 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 a dry powder inhaled antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis.

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