A Chattanooga investment firm on Wednesday announced the results of its ADX-NO5 for the company's Phase 2a clinical trial for the treatment of narcolepsy.
The results were presented at the SLEEP 2013 meeting in Baltimore.
Aerial Biopharma is the third company formed by the successful management team that previously formed Addrenex, which was acquired by Shionogi Pharma in November 2009, and Neuronex, which was acquired by Acorda Therapeutics in 2012.
The investment group for the two completed projects and the current ongoing project is headed by Chattanooga ob/gyn, Dr.
Aerial Biopharma was named an inaugural 2013 Life Sciences Awards winner by the Triangle Business Journal and accounting giant BDO. The award is given to organizations and individuals that reflect power, influence and intellect in the life sciences sector.
A total of 33 patients were randomized and completed both N05 and placebo periods in this double-blind, placebo-controlled, multi-center, crossover study. The average sleep latency across the four 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."