Press release
Savara Provides Business Update in Response to COVID-19 Pandemic
AUSTIN, Texas--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today provided an update on the impact COVID-19 has had on two
About this update from Savara, Inc.
[{"type":"text","content":" AUSTIN, Texas--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA), an orphan lung disease company, today provided an update on the impact COVID-19 has had on two of the Company’s clinical studies in cystic fibrosis (CF). Due to the COVID-19 pandemic, and out of an abundance of caution for people living with CF and clinical study staff, enrollment has been terminated in the Phase 3 AVAIL and the Phase 2a ENCORE studies. With patient safety at the forefront of the decision, and in accordance with guidelines established by the U.S. Food and Drug Administration (FDA), efforts will be made to allow enrolled patients to continue with study treatments and site visit protocols, where possible.\n\n\nThe AVAIL study is evaluating AeroVanc (vancomycin hydrochloride inhalation powder) in people living with CF who have methicillin-resistant Staphylococcus aureus (MRSA) lung infection. Total target enrollment was 200 patients. Enrollment in the adult population is complete, with 55 patients out of a target of 50 enrolled. In the primary analysis population (younger patients between 6-21 years of age) a total of 133 patients out of a target of 150 are enrolled. On March 12, 2020, the Company announced it would continue enrollment of the primary analysis population until Q2 2020. In light of the current pandemic, the Company stopped enrollment earlier than anticipated. Top line results are still expected in early 2021.\n\n\nThe ENCORE study is evaluating Molgradex (inhaled human granulocyte-macrophage colony-stimulating factor, or GM-CSF) in nontuberculous mycobacterial (NTM) lung infection in people living with CF. Total target enrollment was approximately 30 patients and 14 patients are currently enrolled. Due to the exploratory nature of this study, data from the enrolled patients are expected to provide valuable information on the safety, and potential efficacy, of Molgradex in this patient population.\n\n\nThe Company has not experienced disruptions to the planning of a second Phase 3 study of Molgradex for aPAP and continues conversations with the FDA regarding study design and endpoints. Additionally, while the Company has not had any supply chain or manufacturing disruptions due to the current COVID-19 pandemic, the situation is being monitored regularly. With a continued and prolonged health crisis, an interruption could occur.\n\n\n“COVID...