Endpoint; Preparations for Phase 3 Trials are Underway

Aeris Therapeutics, Inc. today announced that the primary efficacy endpoint in Phase 2 clinical trials for its Biologic Lung Volume Reduction (BLVR) System has been achieved.

BLVR is designed to provide a safe non-surgical alternative to lung volume reduction surgery, one of the few available treatments for patients with advanced emphysema. The BLVR system is the first biologic therapy that has been successfully used to remodel the lung and improve breathing function.

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,” commented

Dr. David Dove, CEO of Aeris. “Based on these positive results, we are currently preparing for the initiation of Phase 3 trials.”

Aeris conducted two U.S. Phase 2 studies enrolling 44 patients with upper lobe predominant emphysema to define the optimal dosing regimen for BLVR treatment. Additional trials focusing on the use of BLVR for homogeneous

emphysema are in progress.

The primary endpoint for the Phase 2 trials was a statistically significant reduction in lung volume at three months following treatment, and was achieved in both studies.

In addition, for patients in the high dose group, more than half had clinically significant improvements in breathing function, and more than three quarters had clinically significant improvements in quality of life measures, including activity level, mood and ability to work. BLVR was well tolerated and

the median hospital length of stay was two days. As a comparison, patients undergoing open-chest lung volume reduction surgery have a median hospital length of stay of 10 days.

The primary endpoint was measured using the Residual

Volume to Total Lung Capacity Ratio (RV/TLC).

Improvement in breathing function was assessed using FEV1, a standard pulmonary function test considered to be a primary indication of lung function. This test measures the amount of air a patient can forcibly expel from his or her lungs in one second. Mean FEV1 improvements in the high dose group

exceeded 17 percent at three months.

The Biologic Lung Volume Reduction (BLVR) System is a non-surgical treatment for emphysema that is currently under investigation. A bronchoscope is used to deliver a proprietary mixture of drugs and biologics that form a bioabsorbable gel at diseased areas of the lungs. The gel is a mixture of clotting agents that help deliver the treatment, an antibiotic to prevent infection, and drugs designed to cause a reaction in targeted areas of the lungs–actually using the body’s natural scar formation response to permanently collapse diseased areas of the lungs. This reduction in lung volume creates more space for the non-diseased parts of the lungs to function more effectively.

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