Savara Fully Acquires Serendex, Readies Phase 3 Trial of Inhaled Antibiotic for CF Lung Infections

Savara Pharmaceuticals announced that it has finished with the steps necessary to fully acquire Serendex Pharmaceuticals, strengthening its position as a developer of therapies for rare respiratory diseases.

Savara’s pipeline of products now includes these three, according to a press release:

• Alveodex, a proprietary nebulized formulation of Factor VIIa (recombinant human FVIIa), a protein that exists naturally in the body and plays a key role in the coagulation cascade. Alveodex is currently in preclinical studies to determine how and how well it might treat diffuse alveolar hemorrhage (DAH).
• Molgradex, an inhaled form of granulocyte-macrophage colony-stimulating factor (GM-CSF). This drug is currently in a Phase 2/3 clinical trial to assess it performance in the treatment of autoimmune pulmonary alveolar proteinosis (PAP).
• AeroVanc (vancomycin hydrochloride inhalation powder), a dry powder inhaled antibiotic developed to address the growing challenge of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in patients with cystic fibrosis (CF). Savara recently announced that it is preparing a Phase 3 clinical trial of the antibiotic in CR patients. By delivering vancomycin directly to the site of infection, AeroVanc has been shown to improve the drug’s clinical efficacy and reduce the adverse effects caused by broad-spectrum antibiotics.

Savara previously announced that it expects to begin recruiting CF patients for that Phase 3 trial, expected to take place in the U.S. and Canada, in late 2016.

Infection by MRSA has become increasingly common in the past years, with a prevalence in the U.S. of almost 30 percent among the estimated 32,000 CF patients there. Persistent MRSA infection is linked to faster lung function decline, increased hospitalizations, and reduced survival rates. Currently there are no approved inhaled therapies for MRSA infection in these patients.

The U.S. Food and Drug Administration (FDA) has approved AeroVanc for both fast tracking and as an orphan drug therapy, and designated it an Qualified Infectious Disease Product to give its developer 12 years of market exclusivity.