Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced that additional data from IMPALA, an ongoing pivotal Phase 3 clinical study evaluating Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) will be presented at the 2019 European Respiratory Society (ERS) International Congress to be held in Madrid, Spain from September 28 to October 2.
The annual meeting of the ERS is one of the largest scientific and educational meetings for pulmonologists, scientists, and other healthcare professionals focused on the entire field of respiratory medicine. Data presented from the IMPALA study will provide new insights on the scientific basis and clinical utility of Molgradex for the treatment of aPAP, including patient characteristics, late-breaking efficacy data, clinical outcomes, and safety data.
"We believe that these data, which extend beyond the primary endpoint to include important secondary and exploratory endpoints, provide a more holistic view of the efficacy of Molgradex in improving outcomes for aPAP patients," said Rob Neville, Chief Executive Officer, Savara. "We are confident that the totality of data demonstrates the clinical utility of Molgradex in aPAP patients and we continue to explore the best path for approval with US and European regulatory bodies."
Title: Clinical Features of Autoimmune Pulmonary Alveolar Proteinosis from a Large International Patient Cohort: Baseline Data from the IMPALA Trial
Presenting Author: Bruce Trapnell, M.D.
Date and Time: Wednesday, October 2, 11:30 AM CET / 5:30 AM ET
Session Title: Session 551, Oral Presentation: Rare and Ultra-rare Diseases and the Lungs: Updates and New Perspectives
Location: Room 9B
Savara is an orphan lung disease company. Savara's pipeline comprises Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP), in Phase 2a development for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (CF) and CF-affected individuals with chronic NTM lung infection; and AeroVanc, a Phase 3-stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF. Savara's strategy involves expanding its pipeline of potentially best-in-class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading company in its field. Savara's management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/)
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements regarding the presentation of additional data from IMPALA, that data presented from the IMPALA study will provide new insights on the scientific basis and clinical utility of Molgradex for the treatment of aPAP, including patient characteristics, late-breaking efficacy data, clinical outcomes, and safety data, the belief that these data, which extend beyond the primary endpoint to include important secondary and exploratory endpoints, provide a more holistic view of the efficacy of Molgradex in improving outcomes for aPAP patients, that we are confident that the totality of data demonstrates the clinical utility of Molgradex in aPAP patients, that we continue to explore the best path for approval with US and European regulatory bodies, and Savara's strategy. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the outcome of our planned meeting with the FDA to discuss the IMPALA data and path forward, risks and uncertainties associated with the outcome of our ongoing and planned clinical trials for our product candidates, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara's operations and to conduct or continue planned clinical development programs, the ability to obtain the necessary patient enrollment for our product candidates in a timely manner, the ability to successfully identify product acquisition candidates, the ability to successfully develop our product candidates, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as Molgradex and AeroVanc that are safe and effective for use as human therapeutics, and the timing and ability of Savara to raise additional equity capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
These press releases may also interest you