Steps will also be taken to ensure that those already enrolled in both studies continue to receive treatment and possibly keep with site visit protocols where possible, in accordance with U.S. Food and Drug Administration (FDA) guidelines, the company added.
“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,” Rob Neville, CEO of Savara, said in a press release.
“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,” Neville said.
“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.”
The Phase 3 AVAIL (NCT03181932) trial is evaluating, against a placebo, the effectiveness of AeroVanc, an inhalable dry-powder form of vancomycin (an antibiotic), in treating CF patients with lung infections caused by methicillin-resistant Staphylococcus aureus (MRSA) bacteria.
To date, it has enrolled 133 out of a planned 150 patients between ages 6 and 21, and 55 out of a planned 50 older patients at more than 70 clinical sites in the U.S. and Canada.
Topline results from AVAIL, which opened in September 2017 and is due to conclude in September, are still expected nearly next year, the company said.
ENCORE (NCT03597347), an open-label Phase 2a trial, is evaluating the safety and potential effectiveness of Molgradex, an inhaled form of the artificially produced human protein granulocyte-macrophage colony-stimulating factor (GM-CSF), in treating CF patients with chronic pulmonary non-tuberculous mycobacterial (NTM) infections. (GM-CSF is a protein normally produced by different immune cells in response to certain pathogens, or disease-causing microbes.)
Fourteen of an anticipated 30 adults have been enrolled to date in this 48-week trial, which is set to conclude in June 2021.
Savara is also planning to launch a Phase 3 trial evaluating Molgradex in people with autoimmune pulmonary alveolar proteinosis (aPAP), a rare autoimmune lung disorder. Discussions with the FDA covering the study’s design and clinical endpoints are continuing.
No disruptions to treatment supplies or manufacturing have been noted to date due to the pandemic, Savara reported, adding that it is continuing to monitor the situation as the crisis continues.
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