CAMBRIDGE, Mass.--(BUSINESS WIRE)--Euthymics Bioscience, Inc. today announced that it has initiated a Phase 1 clinical trial of EB-1020, a next-generation drug in development for treating adult attention deficit hyperactivity disorder (ADHD), with low risk of drug abuse liability. This would meet a critical need because current stimulants used to treat ADHD are tightly regulated and often in short supply due to their addictive properties. Peer-reviewed preclinical data demonstrated that EB-1020 affects areas of the brain associated with ADHD. Dosing of healthy volunteers in the EB-1020 Phase 1 trial is now underway. Final results of the study are expected late this summer.
“Initiating the EB-1020 clinical trial is an important milestone that moves Euthymics from a single drug program to a company with a clinical-stage pipeline,” said Anthony A. McKinney, President and CEO of Euthymics. “Since our formation not quite two years ago we have clinical trials for two separate programs, which speaks to the broad applicability of our science and to the exceptional capability of our team.”
Euthymics develops novel triple reuptake inhibitors optimized for specific indications. Amitifadine, Euthymics’ lead product candidate, is a serotonin-preferring triple reuptake inhibitor being tested as a broad spectrum antidepressant. Amitifadine is being evaluated in TRIADE, an advanced phase 2b/3a clinical trial that is currently enrolling patients at 41 sites in the US. EB-1020 is a norepinephrine and dopamine-preferring triple reuptake inhibitor, with a modest effect on serotonin. This pharmacologic profile modulates the brain chemicals most relevant for the treatment of ADHD with a single molecule.
Frank Bymaster, MS, Euthymics’ Chief Scientific Officer and Co-Founder noted: “I was closely involved in the development of the first non-stimulant for attention deficit disorder—a molecule that acts on norepinephrine pathways to help improve focus. For adult ADHD, I've long felt it would help to add a dopamine component that regulates executive function—the person's ability to organize thoughts and activities, prioritize tasks and manage time. EB-1020 acts on both the norepinephrine and dopamine pathways with the aim of improving focus and executive function (complex problem solving), important components for treating adult ADHD."
A study presented at the 50th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in December concluded “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, of Harvard Medical School and director of the Psychiatric Neuroscience Program at Massachusetts General Hospital, and by Euthymics’ Frank Bymaster.
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, in part due to concerns about administering a potentially 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 (TRIADE), 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, to address adult ADHD without the liability of addiction. EB-1020 is a norepinephrine and dopamine-preferring triple in a ratio of 1 to 6 to 14 for norepinephrine, dopamine and serotonin, respectively. It is currently in a Phase 1 clinical trial.
Euthymics is a private corporation with headquarters in Cambridge, Massachusetts. Additional information can be found on the company’s website at www.euthymics.com.