Press release
Savara Reports Fourth Quarter / Year-End 2019 Financial Results and Provides Business Update
Announced Positive Results from IMPALA Open-Label Follow-Up Period That Demonstrate Continued Improvement After Longer Term Exposure to Molgradex Company
About this update from Savara, Inc.
[{"type":"text","content":"\n\nAnnounced Positive Results from IMPALA Open-Label Follow-Up Period That Demonstrate Continued Improvement After Longer Term Exposure to Molgradex\n\n\n\n\nCompany Planning an Additional Phase 3 Study of Molgradex for the Treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)\n\n\n\n\nAnnounced Top Line Microbiology Data from OPTIMA, a Phase 2a Clinical Study in Nontuberculous Mycobacterial (NTM) Lung Infection\n\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA), an orphan lung disease company, today reported financial results for the fourth quarter and full year ending December 31, 2019 and provided a business update.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200312005455/en/Figures 1 and 2 (Graphic: Business Wire)\n\n“Results from the open-label period of IMPALA reaffirm our strong belief that Molgradex could improve outcomes for patients with aPAP, a rare and debilitating lung disease,” said Rob Neville, Chief Executive Officer, Savara. “We continue our conversations with the FDA, as our highest priority is to get clarity from the agency regarding the design and endpoints of a second Phase 3 study in aPAP.”\n\n\nPROGRAM UPDATES\n\n\nMolgradex for aPAP\n\n\n\nAnnounced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of aPAP.\n\n\nWorking in consultation with the FDA to plan a second Phase 3 study.\n\n\nCompleted enrollment in IMPALA-X, an open-label multicenter extension study to determine the long-term safety and use of Molgradex in patients with aPAP. Sixty out of 64 eligible patients enrolled in the study.\n\n\n\nThe Company today announced results from the open-label follow-up period of IMPALA, a Phase 3 study that evaluated Molgradex for the treatment of aPAP. The results, found below, will be discussed on today’s conference call/webcast. Data from the double-blind period of IMPALA were presented at the 2019 European Respiratory Society (ERS) International Congress and can be found on the Articles and Publications page of Savara’s website.\n\n\nIMPALA Study Design\n\n\nIMPALA was a randomized, double-blind, placebo-controlled clinical study designed to compare ...