BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Aerial BioPharma Release: ADX-NO5 Results Presented at SLEEP 2013 Meeting


6/4/2013 2:40:16 PM

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

ADX-NO5 Results Presented at SLEEP 2013 Meeting

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.

Help employers find you! Check out all the jobs and post your resume.


Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES