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.

Local Home Care Franchise Owners Recognized For Superior Customer Satisfaction

Local entrepreneurs and BrightStar Care owners, Rick and Amy Collett, were recognized at the national home-care franchise’s annual owner’s conference as distinguished recipients of the company’s Customer Satisfaction Award. BrightStar Care is a national franchise with more than 300 locations that provide medical and non-medical care to private clients within their homes, as ... (click for more)

Erlanger’s Academic Urologists Present Information On Overactive Bladder And Urinary Incontinence In December

Academic Urologists will host two free information sessions specifically on overactive bladder for men and women on Dec. 7 and on male urinary incontinence and erectile dysfunction on Dec, 10.  Both sessions begin at 6 p.m. at Erlanger East.    "Overactive Bladder is a condition that can be extremely limiting for both men and women. One in three adults may have ... (click for more)

Larry Schumacher Named Chief Executive Officer Of CHI Memorial

The board of directors of CHI Memorial and Catholic Health Initiatives (CHI) have chosen Larry Schumacher as the chief executive officer (CEO) of CHI Memorial effective Jan. 4, 2016 . Mr. Schumacher comes to CHI Memorial from Hospital Sisters Health System (HSHS) based in Springfield, Illinois where he served as system chief operating officer for the past eight years.  ... (click for more)

Chattanooga Under Flood Watch Through Wednesday

With a steady rain set to continue through Wednesday, Chattanooga is under a flood watch. Over four inches of rain are expected in some areas. Here is the advisory from the National Weather Service: ...LOCALIZED FLOODING POSSIBLE ACROSS EAST TENNESSEE AND SOUTHWEST VIRGINIA THROUGH WEDNESDAY MORNING... .THE COMBINATION OF DEEP SUBTROPICAL MOISTURE AND A SLOW MOVING FRONTAL ... (click for more)

City Council, Please Reconsider On The 7-Story Apartment Variance

I would like to thank the Regional Planning Commission and the Regional Planning Agency   for denying the recent application for a variance from the current zoning requirements in place for the 1200 block of Cowart Street. The developers want to build a 7-story parking deck with 141 efficiency and one-bedroom apartments wrapped around three sides in an area with a 48' height ... (click for more)

Roy Exum: My Garden In December

As the fallen leaves confirm today is the first of December, my monthly walk in life’s garden is more foggy than fun. In much-older times, good children would get a piece of candy on Christmas Day while bad ones would receive a lump of coal. So here are some things that deserve a helping of both: A PIECE OF CANDY to the amazingly few who can spy a nest of mistletoe high in area ... (click for more)