Aerial Biopharma Announces Positive Results For ADX-N05 202; A Phase 2b Trial For Narcolepsy

Tuesday, October 1, 2013

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.

TVA Employees Participate In Their 20th CFC Day Of Caring At Chambliss Center For Children

More than 130 TVA employees came to the Chambliss Center for Children campus for their Combined Federal Campaign Day of Caring. This marked the 20th year TVA has chosen to do a Day of Caring at the agency. Although the weather was rainy, the highly-skilled volunteers completed nearly all 50 tasks on the agency’s wish list. Volunteers tackled interior projects such as cleaning, ... (click for more)

Alexander: Rushing Stage 3 Rule Of Electronic Health Records Program A “Disservice To More Than 500,000 Doctors, Thousands Of Hospitals And Millions Of Patients”

The chairman of the Senate health committee Tuesday said that in rushing its rule for the third stage of the electronic health records program, the administration “is doing a disservice to more than 500,000 doctors, thousands of hospitals, and millions of patients.” Chairman Lamar Alexander said: “Instead of taking the time to get the stage 3 rule right, they’ve rushed ahead ... (click for more)

Legislative Hearing On Volkswagen Emissions Scandal To Be Held In Chattanooga Oct. 29; Haslam To Visit VW Plant Wednesday

The Senate Finance, Ways and Means Committee’s Appropriation Subcommittee will be conducting a hearing in Chattanooga to review the financial impact on the state from Volkswagen’s violation of U.S. emissions standards. The meeting will be held at the Hamilton County Department of Education, 3074 Hickory Valley Road, on Thursday, Oct. 29, from 1:30-3:30 p.m.  Members ... (click for more)

Bradley County Commission Decides Not To Provide Animal Pickup Service

Bradley County Commissioners on Monday finally put animal control to rest. It was not easy and it was not without confusion, but in the end, the county will not provide animal pickup service. Confusion began when commissioners were asked to approve the agenda, which included two options for animal control pick up. Item “D” provided for the SPCA of Bradley County to pick ... (click for more)

VW PILOT Crash Landing

The Volkswagen emission scandal proves the point citizen activist, Ms. Helen Burns Sharp, has repeatedly brought to the attention of local government officials. She urged them to "beef up" the PILOT contracts before approving PILOT tax abatements. Any logical person would agree, because it is the only way to recoup a tax loss when unthinkable situations arise. Volkswagen's willful ... (click for more)

Roy Exum: VW’s Primer In Disaster

Volkswagen America has gotten into a real bad “tight,” causing their red-faced leaders to huddle with spin doctors, crisis consultants and countless priests in confessional booths. Conversely, I suspect I have found a solution that would get them out of the mud and hasten their return as one of the top automotive providers in the world. You see, on Aug. 14, 1979, the playbook on ... (click for more)