BALTIMORE, MD- June 3, 2013 – Results from Aerial BioPharma’s Phase 2a clinical trial evaluating the efficacy and safety of ADX-N05 for the treatment of excessive daytime sleepiness in adult subjects with narcolepsy will be presented at the SLEEP 2013 meeting in Baltimore, MD this week. A total of 33 patients were randomized and completed both N05 and placebo periods in this double-blind, placebo-controlled, multicenter, crossover study. The average sleep latency across the 4 trials on the Maintenance of Wakefulness Test (MWT), an objective measure of the severity of excessive daytime sleepiness, was 11.8 minutes longer with N05 treatment than with placebo (p=.0002). In addition, N05 was statistically superior on each of the 4 individual MWT trials (sleep latency 9-14.6 minutes longer, p<.001). On the Epworth Sleepiness Scale, a subjective patient-completed measure of sleepiness, N05 was superior to placebo following 1 week (p<0.0001) and 2 weeks (p=0.0002) of treatment. The Clinical Global Impression-Change (CGI-C) rating, a subjective physician-completed overall improvement scale, showed that at 1 and 2 weeks of treatment, 88% and 76% of subjects improved on N05 versus 27% and 39%, respectively, on placebo (p<0.001, p=0.0016, respectively). N05 was generally well tolerated during the trial.
“Despite the availability of treatments, there remains significant unmet medical need for patients suffering from narcolepsy,” said Richard Bogan, MD, Chief Medical Officer and Director, SleepMed Inc., and the leading study author. “The results of this study suggest that ADX-N05 has the potential to be a significant improvement in treatment.”
Moise Khayrallah, PhD, CEO and co-founder of Aerial Biopharma, said “We are very pleased with the results of the Phase 2a trial and are eagerly anticipating the results of our Phase 2b clinical trial, expected in the third quarter of this year. Our company is very focused on accelerating the development timeline for ADX-N05 so that we can bring this important potential treatment to patients as soon as possible.”
About Aerial Biopharma
Aerial is the third company from the management team led by Khayrallah, Steve Butts and Gary Bream PhD, all privately held and located in the Research Triangle Park, NC area. A development based company focused on central nervous system conditions, the company currently has three assets in development; ADX-N05 for the treatment of Narcolepsy; Prostatic Acid Phosphotase (PAP), a biologic for the treatment of acute and chronic pain; and Nasal Granisetron for the treatment of Chemotherapy and Radiation induced Nausea and Vomiting. The same management team members of Aerial also founded Addrenex which was acquired by Shionogi Pharma in November 2009 and Neuronex, which was acquired by Acorda Therapeutics in 2012.