Savara announced that it has halted two studies: the Phase 2a ENCORE study of Molgradex inhaled human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infections in cystic fibrosis patients and the Phase 3 AVAIL studies of AeroVanc vancomycin DPI for the treatment of MRSA lung infections in cystic fibrosis patients. The company said that patients in the trials would be allowed to continue treatment “where possible.”
The ENCORE study was initiated in April 2019 and so far has enrolled 14 patients out of a targeted 30. The company is also developing Molgradex for the treatment of NTM lung infections in non-CF patients and for autoimmune pulmonary alveolar proteinosis (aPAP). Savara said that planning for a second Phase 3 trial of Molgradex for aPAP is still underway.
The AVAIL study was initiated in September 2017. According to Savara, enrollment of adults in the study is complete; for patients aged 6-21, the study has enrolled 133 of the targeted 150. The company affirmed that it still expects top line results in early 2021.
Savara CEO Rob Neville said, “COVID-19 has profoundly affected the healthcare sector, including clinical studies. The health and safety of our patients, and the communities in which we operate, are our highest concern. To mitigate any additional risk to people living with CF, who face an increased risk of serious complications from COVID-19, we are halting enrollment in the AVAIL and ENCORE studies. For patients continuing in the studies, we are following guidance from governing bodies regarding clinical study conduct and we remain in close contact with our sites and investigators to monitor this evolving situation.”
Read the Savara press release.
