Not recently SBIR involved, Savara (NASDAQ:SVRA) is an orphan lung disease company whose lead program - Molgradex - is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). With a management team with significant experience in orphan drug development and pulmonary medicine, identifying unmet needs in early January 2017, Mast Therapeutics Inc. - also an SBIR-involved firm - merged with Savara Inc. The stockholders of Savara became majority owners of Mast and operations of the two companies were combined taking on the Savara name and continuing to be headquartered in Austin, TX. Strategy enabled Savara to avoid an IPO - then in June 2017 being able to complete a $40M FOPO. In June 2016, to expand its pipeline of orphan respiratory therapies, Savara Pharmaceuticals had acquired Danish firm Serendex Pharmaceuticals AS for an undisclosed sum in an all-stock deal, which also includes milestone-based earn-outs. Originally founded in Kansas where the firm licensed technology from the University of Kansas prior to moving to Austin, Texas, Savara is a specialty pharmaceutical company focused on innovative drugs for the treatment of serious and life-threatening rare respiratory diseases. Savara Pharmaceuticals’ lead product candidate, AeroVanc™ (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. AeroVanc is being developed for the treatment of MRSA lung infection in cystic fibrosis patients and other high-risk patient populations in the critical care setting. Vancomycin administered by IV is the antibiotic of choice for MRSA-related bronchopneumonia, however, IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting. By delivering vancomycin directly to the site of infection in the lungs, AeroVanc is expected to improve clinical efficacy and reduce adverse effects due to systemic drug exposure. AeroVanc was recently granted orphan drug status by the U.S. Food and Drug Administration.
