Press release
Savara Announces New England Journal of Medicine (NEJM) Publication of IMPALA Study Results
Inhaled Molgramostim Improved Outcomes that Reflect Physiological, Radiological, Biochemical, and Clinical Manifestations of aPAP AUSTIN, Texas--(BUSINESS
About this update from Savara, Inc.
[{"type":"text","content":"\nInhaled Molgramostim Improved Outcomes that Reflect Physiological, Radiological, Biochemical, and Clinical Manifestations of aPAP\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced that results from the Phase 3 IMPALA study were published online in NEJM. The manuscript, titled “Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis,” appears in the September 7, 2020 online version of the publication and can be found at www.nejm.org.\n\n\nThe IMPALA study evaluated molgramostim nebulizer solution (an inhaled granulocyte-macrophage colony-stimulating factor) for the treatment of aPAP and was a 24-week, double-blind, placebo-controlled study. Patients were randomized to one of three arms, molgramostim 300 µg continuous daily dosing, molgramostim 300 µg daily dosing intermittently every other week, or placebo. The double-blind period was followed by a 24/48-week open-label period where all arms received molgramostim 300 µg daily dosing intermittently every other week. The A-aDO2 gradient was the primary endpoint in the study. Key secondary endpoints included the St. George’s Respiratory Questionnaire (SGRQ) total score, six-minute walk distance, and time-to-requirement for whole lung lavage.\n\n\n“IMPALA was the largest treatment trial ever conducted in aPAP patients and demonstrated that daily administration of inhaled molgramostim led to greater improvement than placebo in outcomes that reflect physiological, radiological, biochemical, and clinical manifestations of aPAP,” said Bruce Trapnell, M.D., Lead Investigator of the IMPALA study in the U.S. “Importantly, molgramostim was well tolerated with no notable safety concerns. I believe that the drug will be a significant improvement to the care of aPAP patients.”\n\n\nWhile IMPALA did not meet the primary endpoint of A-aDO2 in the primary analysis, replacement (by imputation) of invalid A-a DO2 data for four severely affected patients who required continuous nasal oxygen therapy resulted in a change in A-aDO2 from baseline to week 24 that was greater in patients receiving continuous administration of molgramostim compared to placebo. Oxygen therapy during arterial blood gas measurement was permitted by protocol for ethical reasons (n=1 in each molgramostim arm, n=2 in the placebo arm). The estimate...