Aerial BioPharma, which has several Chattanooga investors, announced on Tuesday positive results from a Phase 2b clinical study of ADX-N05 in patients with Excessive Daytime Sleepiness associated with narcolepsy. After completing a successful Phase 2a proof-of concept trial in mid-2012, Aerial began the 12-week, 93 patient, Phase 2b study in September 2012 to validate the results in a larger patient population with a longer duration of treatment.
“The preliminary results are remarkable and have the opportunity to have significant impact on the standard of care for patients with narcolepsy” said Dr. Todd Swick, a clinical investigator in the trial and assistant clinical professor of Neurology, University of Texas School of Medicine-Houston .
Given the positive results, the company is now planning a strategic asset sale to accelerate the development of N05. “We are very pleased that we were able to replicate the results from our previous study and are excited about the potential to help patients with this debilitating disease. As a development-stage company, we have turned our focus to finding a strategic partner that will complete the development and maximize commercialization of this important asset.” said Dr. Moise Khayrallah, CEO and co-founder of Aerial.
This news comes on the heels of FDA’s Patient-Focused Drug Development Meeting on narcolepsy held on Sept. 24, that highlighted the need for additional research and treatment. Due to patients’ clamor, narcolepsy was the first rare disease featured in this series of meetings.
Aerial is the third-privately held company from the management team led by Khayrallah, Steve Butts and Gary Bream PhD, all located in the Research Triangle Park, NC area. Since launching Addrenex Pharmaceuticals in 2006, the team has raised and deployed over $30 million for various drug development programs in central nervous systems conditions. Addrenex was acquired by Shionogi Pharma in November 2009 and Neuronex, the team's second company, was acquired by Acorda Therapeutics in 2012. Aerial licensed N05 from SK Biopharmaceuticals.