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.


Morning Pointe Residents Put Contest Earnings Toward Alzheimer's Fundraiser

Morning Pointe of Chattanooga at Shallowford was the regional winner of the corporate Spring Fling contest.  The assisted community was rewarded with $550 for a celebration.  Instead of having a party, the directors of Morning Pointe of Chattanooga knew that residents would want to share their prize with the community so they decided to put it towards one of their biggest ... (click for more)

CHI Memorial Medical Group Welcomes David Castrilli, M.D. To CHI Memorial Internal Medicine Associates

CHI Memorial Medical Group announces David Castrilli, M.D. has joined CHI Memorial Internal Medicine Associates.  Dr. Castrilli received his medical degree from St. George’s School of Medicine. He completed his residency at University of Tennessee, Chattanooga.  His specialty is internal medicine. “We are pleased to welcome Dr. Castrilli into CHI Memorial Internal ... (click for more)

Woman Seriously Injured After Plowing Into Rossville Boulevard Car Dealership Saturday Evening

A woman was seriously injured after plowing her vehicle into a car dealership on Rossville Boulevard on Saturday evening.   At approximately  6:49 p.m., the Chattanooga Police Department responded to 2818 Rossville Blvd. on an accident with injuries.   A blue vehicle traveling at a high rate of speed lost control.  The vehicle crashed ... (click for more)

Boy, 4, Struck By Vehicle Near Tunnel Boulevard

A four-year-old boy was struck by a vehicle near Tunnel Boulevard on Saturday afternoon. A t approximately 4:20 p.m.,  the Chattanooga Police Department responded to 3400 Through St. on a c hild struck by a vehicle.  T he victim was conscious when officers arrived. He was transported to a local hospital. I nvestigators are continuing to compile ... (click for more)

DWT Is DUI

A routine narrative of a DUI arrest report goes something like this:   The defendant was operating a motor vehicle in the 00 block of sonsoroad. The driver was weaving back and forth across the marked roadway. The defendant drove through a stop sign. Was stopped at an intersection despite the traffic light was green. Entered the lane of another vehicle and caused a ... (click for more)

Roy Exum: What Voters Think

There are over 9,000 students who attend Quinnipiac University in Hamden, Conn., which – in an effort to be relative -- is just a touch smaller than our UT-Chattanooga. What makes Quinnipiac unique is that it is home of The Quinnipiac University Polling Institute, which produces what’s called the “Q Poll” because hardly anybody knows how to pronounce “Kwin-uh-pe-ack.” The Q ... (click for more)