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.


Free Smoking Cessation Courses Begin In October

More than 16 million Americans live with a disease caused by smoking, according to The Centers for Disease Control and Prevention.  It also reports one in four adults still use tobacco products, at least occasionally.  The American Lung Association lists smoking as the leading cause of preventable death.   CHI Memorial’s Rees Skillern Cancer Institute offers a ... (click for more)

BlueCross Plans Earn 4-Star Quality Rating For 2016

Two BlueCross BlueShield of Tennessee plans each earned an overall rating of 4 out of 5 stars for 2016 from the National Committee for Quality Assurance, an accrediting body for health insurance plans. "The star ratings, debuted by NCQA in 2015, are designed to help consumers understand how well a health insurance plan supports its members in getting recommended care. With ... (click for more)

Boy In Critical Condition; Another Person Stabbed And Man Shot In Dispute At Apartments On Citico Avenue

A boy is in critical condition after being stabbed on Sunday afternoon in what police described as a dispute between neighbors. One other person was stabbed and a man was shot in the stomach in the melee in the 2700 block of Citico Avenue. The injuries to the second person stabbed in the neck and the shooting victim were said to be not life-threatening. The 12:45 p.m. incident ... (click for more)

Woman, 25, Shot On Dodson Avenue Early Sunday Afternoon

A 25-year-old woman was shot onDodson Avenue just after noon on Sunday. Officers with the Chattanooga Police Department were notified at 12:13 p.m. by a local hospital that a victim arrived with a gunshot wound. The shooting reportedly occurred in the 1300 block of Dodson Avenue. Shaday Millener arrived at the hospital in a personal vehicle with a non-life threatening ... (click for more)

Patrol Cars Donation To Kevin Muhammad's Nation Of Islam Sets A Dangerous Precedent

Re: City Police donating two patrol cars to Kevin Muhammad's Nation of Islam: While I know it's unpopular to mention the wisdom of separation of church and state, this sets a dangerous precedent and should meet with concern from everyone who values religious and secular freedom. What's next? Southern Baptists getting old city parking scooters to patrol church parking lots ... (click for more)

Roy Exum: Thanks A Lot For Nothing

Somebody should have gotten an award last Tuesday when a 90-minute “education summit” involving our school leaders, politicians and media produced absolutely nothing. Zilch. Zero. Oh, there are a number of candidates we could give an award for “nothing,” both in our school district and on its fringes. Yet to find Tennessee Commissioner of Education Candice McQueen brought her high-and-mighty ... (click for more)