Enrollment Info Updated on Phase 3 Trial Assessing AeroVanc for MRSA Infection in CF
Enrollment for a Phase 3 clinical trial testing AeroVanc in patients with cystic fibrosis with methicillin-resistant Staphylococcus aureus (MRSA) lung infections is expected to be completed in the third quarter of this year — between July and September.
AeroVanc is an inhaled formulation of the antibiotic vancomycin hydrochloride being developed by Savara Pharmaceuticals for difficult-to-treat MRSA infections.
These infections cause rapid lung function decline in patients with cystic fibrosis. The inability of medications to reach the site of infection makes it increasingly harder to treat. With AeroVanc, the inhalation route of the powdered antibiotic may improve accessibility, upping the chances of clearing MRSA.
The multicenter Phase 3 trial (NCT03181932) called AVAIL was designed to test the efficacy of AeroVanc in clearing MRSA infections in cystic fibrosis patients and improving lung function. The study has enrolled 143 participants so far for a projected total of 200 CF patients with MRSA lung infections.
Enrollment is ongoing at more than 80 study centers across the U.S. and Canada. The screening rates for participation in the trial have been high, Savara says.
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“AVAIL is a high priority for the community of CF care centers and, as demonstrated by the high screening numbers, we have been successful in reaching a large number of MRSA-affected people and their families,” Patrick Flume, MD, the principal investigator for AVAIL and director of the Adult CF Center at the Medical University of South Carolina in Charleston, said in a press release.
The AVAIL trial plans to recruit patients from two different age groups: 150 patients ages 6 to 21 years, and 50 participants older than 21.
Despite a high screening rate, enrollment in the 6-to-21-year-old age group has been slow, according to Savara. Disease worsening is the leading cause for not meeting the trial’s eligibility requirements. Pulmonary exacerbation after screening and before being assigned the treatment deteriorates the patient’s lung function to ranges unacceptable for starting the study. Due to these factors, the rate of screening failures is at 46% in this age group.
“As shown by the number of pulmonary exacerbations just prior to randomization, people with MRSA lung infection have a strong need for improved treatment options,” Flume said. “I am optimistic that AeroVanc could improve outcomes for people living with MRSA and become the first [U.S. Food and Drug Administration] approved therapy to treat this debilitating disease.”
According to Savara, preliminary results of the trial are expected in early 2020. More information, including how to participate in the AVAIL trial is available here.