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.
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.