A new drug to treat excessive daytime sleepiness associated with narcolepsy has shown positive results from a phase 2b clinical trial, US-based Aerial Biopharma has announced this week.
University of Texas School of Medicine-Houston assistant clinical professor of neurology and clinical investigator in the trial Dr Todd Swick said the preliminary results have the opportunity to have a significant impact on the standard of care for patients with narcolepsy.
After completing a successful Phase 2a proof-of concept trial in mid-2012 for narcolepsy drug ADX-N05, Aerial BioPharma conducted a second 12 week 93 patient phase 2b study to further validate the results in a larger patient population and with longer duration of treatment.
The company, which is a privately held biopharmaceutical company focused on developing biologics and small molecules for medical conditions in the central nervous system, is now planning a strategic asset sale to accelerate the development of the drug.
Aerial CEO and co-founder Dr Moise Khayrallah said: "As a development-stage company, we have turned our focus to finding a strategic partner that will complete the development and maximise commercialisation of this important asset."
On 24 September, the FDA held a patient-focused drug development meeting on narcolepsy to highlight the need for research and development for the condition.
Narcolepsy is a life-long condition; it is a chronic neurological disorder caused by the brain’s inability to regulate sleep-wake cycles normally.
Patients with narcolepsy often experience disturbed nocturnal sleep and an abnormal daytime sleep pattern.
Narcolepsy with cataplexy is estimated to affect about one in every 3,000 Americans. It is a sudden and transient episode of loss of muscle tone accompanied by full conscious awareness, often triggered by emotions such as laughing, crying, terror.
Photo: Patients with narcolepsy often experience disturbed nocturnal sleep and an abnormal daytime sleep pattern. Image: courtesy of shawnisa.