Aeris Therapeutics Inc, Woburn, Mass, announced its Biologic Lung Volume Reduction (BLVR) System achieved the primary efficacy endpoint in Phase 2 clinical trials. The primary endpoint of the trial was a statistically significant reduction in lung volume at 3 months after treatment.
During the Phase 2 clinical trial, the primary endpoint was achieved in both of the 2 studies. Additionally, more than half of the patients who received a high dosage of BLVR during clinical trials experienced clinically significant improvements in breathing function, and more than 75% of them had clinically significant improvements in quality of life measures such as activity level and mood.
“The Phase 2 clinical trial data show that BLVR is well tolerated and is associated with significant improvements in breathing function, symptoms, and quality of life,” says David Dove, MD, CEO of Aeris. “Based on these positive results, we are currently preparing for the initiation of Phase 3 trials.”
The BLVR system may be a safe non-surgical alternative to current invasive treatment options for patients with advanced emphysema. Additional trials on the use of BLVR for homogeneous emphysema are in progress.
“We are very encouraged by these results, which suggest that BLVR may be a dramatically safer but still effective alternative to lung reduction surgery, an invasive procedure that involve a substantial degree of risk for emphysema patients. There is a tremendous need for better options for the millions of people who suffer from emphysema,” says Gerard Criner, MD, investigator in the study.