Neurovance Receives Notice of Allowance for Composition of Matter Patent and Initiates Clinical Trial of New SR Formulation of EB-1020
Published: Feb 21, 2013
EB-1020 is being developed to improve efficacy compared to existing non-stimulants, but to do so with less risk of abuse liability and diversion, or non-medicinal use, than the current stimulants (amphetamine and amphetamine-like medications) that are the standard of care in ADHD. This phase 1 “umbrella” study will evaluate pharmacokinetics, food effects, and tolerability of a sustained-release formulation with multiple dose escalation in healthy volunteers. Results are expected during the second quarter, with plans for a phase 2a pilot study in the US later this year. According to IMS Health, the US ADHD market in 2011 was valued at $7.9 billion with significant growth coming from the adult segment of the market.
This follows recent completion by Neurovance of an initial phase 1 clinical trial of EB-1020 that evaluated single and multiple ascending doses in normal subjects. EB-1020 was well tolerated and safe across a broad dose range. However, the study also showed the plasma half-life of the immediate-release (IR) formulation was likely too short for optimal use in ADHD. Following that study, Neurovance developed sustained-release formulations of EB-1020 to improve dosing convenience for adults with ADHD.
Anthony A. McKinney, President and CEO of Neurovance, noted, "Taken together, these developments combine to significantly support the value of EB-1020. The US composition of matter patent is a critically important milestone, and with initiation of this phase 1 trial using the SR formulation, we have taken another step towards the treatment of adult ADHD. This sets the stage for our near-term plans to move beyond healthy volunteers and into patients in a phase 2a trial that should be initiated this fall."
EB-1020 is being developed for adult ADHD based on its potent norepinephrine (NE) reuptake inhibition, combined with moderate dopamine (DA) reuptake inhibition and very modest serotonin (5-HT) reuptake inhibition. EB-1020 has a norepinephrine profile similar to the pharmacology of the first-generation non-stimulant atomoxetine, but unlike atomoxetine, EB-1020 adds moderate dopamine neurotransmission that is believed to offer the potential for improved efficacy in ADHD. The level of dopamine activity associated with EB-1020 is less than that of stimulants – an important distinction because stimulants are addictive because they greatly activate dopamine neurotransmission, resulting in these Schedule II products (i.e. controlled substances) being tightly regulated by the government. By contrast, EB-1020 may have a lower risk of drug abuse liability and diversion, as suggested by preclinical and clinical data to-date.
The phase 1 umbrella trial is being conducted on behalf of Neurovance by INC Research and Nucleus Network in Melbourne, Australia.
About Neurovance, Inc.
Neurovance was spun out of Euthymics Bioscience, Inc. to advance EB-1020, a norepinephrine and dopamine-preferring reuptake inhibitor for ADHD. In addition to EB-1020, Neurovance also holds a substantial portfolio of research-stage reuptake inhibitors.
Euthymics and Neurovance are private corporations with common headquarters in Cambridge, Massachusetts. Additional information can be found on the Euthymics website at www.euthymics.com.