Neurovance Inc. today announced interim results from its phase 2a pilot study of EB-1020 SR in adult patients with all subtypes of ADHD. With the four week trial fully enrolled and dosing completed in the majority of patients, the results indicate a statistically significant improvement in ADHD symptoms. The 40 patient trial was led by Dr. Andrew J. Cutler at the Florida Clinical Research Center and is the first evaluation of the safety and efficacy of EB-1020 SR in a patient population.
The trial was a flexible-dose single-blind placebo lead-in design exploring doses ranging from 300 to 500 mg/day given as a divided dose BID. Specifically, the interim results demonstrated a 21.5 point improvement in the primary outcome measure at week four, a reduction in ADHD symptoms compared to baseline as measured by the ADHD Rating Scale IV (ADHD-RS-IV). These findings were statistically significant (p<0.0001). Additionally, improvement in ADHD symptoms was observed quickly, with 80% of the peak benefit observed by the second week of therapy.
"We could not be more pleased by these interim results," said Anthony A. McKinney, President and CEO of Neurovance. "By week four, 72% of all patients meet the generally accepted definition of a responder on two validated scales, the CGI-I and the ADHD-RS, and EB-1020 SR has been safe and well-tolerated thus far with most adverse events reported as both mild and transient."
The level of reduction in ADHD symptoms with EB-1020 SR was comparable to that observed in other adult ADHD trials investigating standard stimulant medications under similar trial conditions. EB-1020 SR, a triple reuptake inhibitor, modulates norepinephrine (NE), dopamine (DA) and, to a lesser extent, serotonin (5-HT) reuptake in a ratio of 1 to 6 to 14. EB-1020 SR has shown a low risk of abuse potential in preclinical studies and does not appear to be rewarding in man.
"EB-1020 SR is a hybrid between the stimulants and the non-stimulant, norepinephrine-only approach to ADHD," said Frank P. Bymaster, Chief Scientific Officer of Neurovance. "I was involved in the development of atomoxetine, the first non-stimulant approved for ADHD so I understand the strengths and the weaknesses of a norepinephrine-only medication. At the same time, stimulants are effective but they have issues as well. That is why we are excited about this hybrid approach: a potentially more effective non-stimulant with less risk of drug abuse or diversion than stimulants for adults with ADHD."