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Savara Initiates Phase 2 Clinical Trial of AeroVanc for MRSA Lung Infection in Cystic Fibrosis Patients


4/18/2013 9:52:46 AM

AUSTIN, Texas, April 18, 2013 /PRNewswire/ --Savara Pharmaceuticals announced today that the first patient has started study drug treatment in a Phase 2 clinical trial evaluating the safety and efficacy of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis (CF) patients. AeroVanc is the first inhaled antibiotic being developed to address the growing population of MRSA lung-infected CF patients.

Persistent MRSA lung infection in CF patients has been associated with increased use of intravenous (IV) antibiotics, increased hospitalizations, faster decline of lung function, as well as shortened life-expectancy. Persistent MRSA lung infection in CF patients is difficult to eradicate or manage using oral or IV antibiotics, and there is no standard of care to manage the infection in CF patients. IV vancomycin is the antibiotic of choice for acute exacerbations of MRSA lung infections in CF patients, but the burden related to IV administration, as well as poor penetration of vancomycin into the lungs and systemic toxicities, limit its use in a chronic setting. In contrast to the established treatment of Pseudomonas aeruginosa lung infection with inhaled antibiotics, there is no FDA-approved inhaled antibiotic treatment available for MRSA lung infection.

Savara's Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study in 80 CF patients at 22 CF centers nationwide. Patients will receive either 32 mg or 64 mg doses of AeroVanc or a corresponding placebo twice daily for 28 days. The primary objective of the study is to evaluate the efficacy of AeroVanc in reducing the quantity of MRSA colony forming units in the sputum cultures. The secondary objectives include evaluation of the efficacy of AeroVanc in improving lung function, reducing respiratory symptoms reported by the patients, and reducing the use of other antibiotics. Study results are expected in the first quarter of 2014.

"We are encouraged by the recent FDA approval of Novartis' dry-powder TOBI Podhaler for Pseudomonas aeruginosa infections in CF patients. An inhaled dry powder form of vancomycin for MRSA infection will be a logical addition to this and other treatment options available for CF patients," said Rob Neville, CEO of Savara Pharmaceuticals. "We are further encouraged by the strong interest and support of key opinion leaders, and the feedback that AeroVanc is exactly what the CF care community has been waiting for."

Details of the AeroVanc Phase 2 study can be found at www.clinicaltrials.gov (study identifier NCT01746095).

About AeroVanc

Intravenous vancomycin is the antibiotic of choice for MRSA-related bronchopneumonia, however, the burden of IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting. AeroVanc (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. By targeting vancomycin directly to the lungs, AeroVanc is expected to improve clinical efficacy and reduce side effects due to systemic drug exposure.

About Cystic Fibrosis

Cystic fibrosis is a life-shortening genetic disease characterized by thick, sticky mucus in the lungs and frequent lung infections, which result in loss of lung function. As the disease progresses, the lungs of CF patients are typically infected with bacteria that are difficult to eradicate. Physicians have been using nebulized antibiotics to treat these infections and have sought new options for treatment in the chronic care setting. The first successful reformulation of an antibiotic into dry powder inhaled therapy is the recently FDA-approved TOBI Podhaler (tobramycin inhalation powder) for Pseudomonas aeruginosa infections in CF patients. Infection by MRSA has become increasingly common with a prevalence of almost 30 percent of the estimated 30,000 CF patients in the U.S.

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, is the first dry powder inhaled antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis. Savara receives funding for development of AeroVanc from the National Heart, Lung and Blood Institute of the National Institutes of Health under Award Number R44HL112393. The award spans 30 months and is subject to continued progression of the AeroVanc program. For more information about the company, please visit www.savarapharma.com.

SOURCE Savara Pharmaceuticals



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