Press release
Savara Reports First Quarter 2020 Financial Results and Provides Business Update
Company Announces Expected Design for IMPALA 2, the Next Phase 3 Study of Molgradex in aPAP AUSTIN, Texas--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA), an
About this update from Savara, Inc.
[{"type":"text","content":"\nCompany Announces Expected Design for IMPALA 2, the Next Phase 3 Study of Molgradex in aPAP\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA), an orphan lung disease company, today reported financial results for the first quarter ending March 31, 2020 and provided a business update.\n\n\n“With the recent clarity around the IMPALA 2 study design, along with the expansion of our pipeline with the Phase 3 Apulmiq development program, 2020 has kicked off with a strong start,” said Rob Neville, Chief Executive Officer, Savara. “We are now working diligently to get these two studies initiated as soon as possible.”\n\n\nRecent Developments\n\n\nMolgradex for autoimmune pulmonary alveolar proteinosis (aPAP)\n\n\n\nBased on discussions with the U.S. Food and Drug Administration (FDA), the Company believes the second Phase 3 study will be a randomized, double-blind, placebo-controlled study of Molgradex 300 µg administered once daily continuously compared to matching placebo over 48 weeks. 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.\n\n\n\nApulmiq for non-cystic fibrosis bronchiectasis (NCFB)\n\n\n\nObtained the global rights to develop and commercialize Apulmiq (inhaled ciprofloxacin).\n\n\nThe Company expects to work with the FDA to plan a confirmatory Phase 3 study that will be based on key learnings from previous studies of inhaled antibiotics for NCFB.\n\n\n\nAeroVanc for methicillin-resistant Staphylococcus aureus (MRSA) lung infection\n\n\n\nDue to COVID-19 concerns, the Company closed enrollment in the Phase 3 AVAIL study. Total target enrollment was 200 patients. Enrollment in the adult population completed, with 55 patients out of a target of 50. One hundred and thirty-three patients were enrolled in the primary analysis population (younger patients between 6-21 years of age) out of a target of 150. Top line results are still expected in early 2021.\n\n\n\nMolgradex for nontuberculous mycobacterial (NTM) lung infection\n\n\n\nDue to COVID-19 concerns, the Company closed enrollment in the Phase 2a ENCORE study. Fourteen patients out of a target of ~...