Euthymics Bioscience, Inc. Presents Data That Support Advancing EB-1020 into Clinical Trials for Adult ADHD

—Data Presented at ACNP Annual Meeting—

—EB-1020 Is a Triple Reuptake Inhibitor Optimized for ADHD without Drug Abuse Liability—

—Data Position EB-1020 as a Second Drug Development Program for Euthymics following Amitifadine for Depression—

CAMBRIDGE, Mass. & WAIKOLOA, Hawaii--(BUSINESS WIRE)--Dec 7, 2011 - Euthymics Bioscience, Inc. today announced that it has presented preclinical data demonstrating that EB-1020, a next-generation product candidate for adult attention deficit/hyperactivity disorder (ADHD), may be effective for treating ADHD without the burden of drug abuse liability. Euthymics' EB-1020 is a novel triple reuptake inhibitor formulated for the treatment of ADHD as a norepinephrine and dopamine-preferring triple, with a small effect on serotonin. This combines the pharmacology of the brain chemicals most relevant for the treatment of ADHD in a single molecule—norepinephrine is believed to help with focus, while the increased dopamine is believed to improve problem solving capabilities, and may also lead to a faster speed-of-onset. EB-1020 is also active in animal models of depression, a common co-morbidity of ADHD. The data were presented at the 50th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Hawaii.

Euthymics develops novel triple reuptake inhibitors optimized for specific indications. Amitifadine, Euthymics' lead product candidate, is a serotonin-preferring triple reuptake inhibitor now under development as a broad spectrum antidepressant. Amitifadine is being evaluated in an advanced phase 2b/3a clinical trial, TRIADE, which is currently enrolling patients in the US.

“We have filed a Clinical Trial Application (CTA) in Canada and plan to initiate the first-in-man study in Toronto shortly,” said Anthony A. McKinney, President and CEO of Euthymics. “EB-1020 is intended to be a comprehensive treatment for multiple symptoms associated with ADHD but without the liability of addiction. This is especially important in light of current shortages of stimulants commonly used to treat ADHD, which are controlled substances with production tightly regulated by government agencies.”

A study presented at the ACNP conference demonstrated that in an animal model of ADHD predictive of human response, EB-1020 was shown to have a unique profile that may activate cortical regions in the brain involved in attention and execution of cognitive functions. The presentation concludes “these data suggest that EB-1020 is a novel agent with improved pharmacotherapy for pediatric and adult ADHD patients, with benign safety, tolerability profiles, and a low incidence of drug abuse liability.”

The study was presented by lead author Frank Tarazi, PhD, MBA, Associate Professor of Psychiatry & Neuroscience, Harvard Medical School and Director, Psychiatric Neuroscience Program, McLean Division of Massachusetts General Hospital, and by Frank Bymaster, MS, Chief Scientific Officer and Co-Founder of Euthymics. Mr. Bymaster has previous experience in the development of non-stimulants for ADHD.

A preclinical pharmacology study previously presented by Mr. Bymaster showed that EB-1020 markedly increased norepinephrine and dopamine levels in brain regions thought to be involved in ADHD. Furthermore, EB-1020 did not stimulate locomotor activity, suggesting a low risk of drug abuse liability.

According to the National Institute of Mental Health, ADHD causes significant impairment in adults, resulting in difficulty functioning, underachievement in school and at work, and poor social and family relations. ADHD affects approximately 10 million adult Americans (about 4 1/2 percent of the population). However, only approximately one in 10 patients is treated, partially because of concerns about administering an addicting stimulant drug to adults.

About Euthymics Bioscience

Euthymics Bioscience, Inc. is a neuroscience-focused clinical-stage company developing next-generation treatments for central nervous system disorders. The company's lead product candidate amitifadine, currently in a phase 2b/3a clinical trial for depression, is a triple reuptake inhibitor that acts on serotonin, norepinephrine and dopamine in the specific ratio of 1 to 2 to 8, respectively, and is given as monotherapy (a single capsule). Amitifadine has demonstrated proof-of-concept efficacy as treatment for major depression without causing weight gain or loss of sexual function, which often lead to poor adherence to standard antidepressants.

Euthymics is also developing a second triple reuptake inhibitor, EB-1020, for adult ADHD. Unlike amitifadine, EB-1020 is a norepinephrine and dopamine-preferring triple in a ratio of 1 to 6 to 14 for norepinephrine, dopamine and serotonin, respectively.

Euthymics is a private corporation with headquarters in Cambridge, Massachusetts. Additional information can be found on the company's website at www.euthymics.com.

 

Contact: Euthymics Bioscience, Inc.
Anthony A. McKinney, 617-758-0300
or
Media:
BioCom Partners
Stephen Gendel, 212-584-2276

 

 

Posted: December 2011

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