Press release
Savara Reports Second Quarter 2020 Financial Results and Provides Business Update
Announces Final Clinical Study Design for IMPALA 2, the Next Phase 3 Study of Molgradex in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Study Expected to
About this update from Savara, Inc.
[{"type":"text","content":"\nAnnounces Final Clinical Study Design for IMPALA 2, the Next Phase 3 Study of Molgradex in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)\n\n\nStudy Expected to Start in Q1 2021 \n\n AUSTIN, Texas--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA), an orphan lung disease company, today reported financial results for the second quarter ending June 30, 2020 and provided a business update.\n\n\n“With a final design for IMPALA 2, we are working diligently on study preparations and expect it to start in the first quarter of next year,” said Rob Neville, Chief Executive Officer, Savara. “Building on the learnings from the first IMPALA study, and following constructive discussions with the regulatory agencies, we are confident in the study design and believe IMPALA 2 will effectively measure the potential efficacy and safety of Molgradex to treat aPAP.”\n\n\nRecent Developments\n\n\nMolgradex for aPAP\n\n\n\nThe Phase 3 IMPALA 2 study, which incorporates feedback from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), will be a randomized, double-blind, placebo-controlled study evaluating Molgradex for the treatment of aPAP. A total of 160 patients will be enrolled at approximately 50 sites across the U.S., Canada, Japan, South Korea, and select countries in Europe. Patients will be randomized in one of two arms: Molgradex 300 µg administered once-daily continuously or matching placebo. The primary endpoint will be change from baseline to week 24 in diffusion capacity of the lungs (DLCO) percent predicted. Secondary endpoints will be change in baseline to week 24 in St. George’s Respiratory Questionnaire (SGRQ) Total Score, SGRQ Activity Component, and exercise capacity using a treadmill test. While efficacy endpoints will be assessed at week 24 for primary analyses, the placebo-controlled period will be 48 weeks to better assess the durability of treatment effect, as well as long-term safety of the drug, which is intended to be administered chronically. At the end of the 48-week double-blind period, both treatment arms will rollover into a 48-week open-label follow-on period in which all patients will receive Molgradex 300 µg administered once-daily.\n\n\nThe study is expected to start in the first quarter of 2021.\n\n\n\nApulmiq for non-cystic fibrosis bronchiectasis (NCFB)\n\n\n\nThe Company is further ...