The United States Patent and Trademark Office (USPTO) has issued Neurovance, a Cambridge, Mass.-based company spun out of Euthymics Bioscience, a notice of allowance for a composition of matter patent for EB-1020, providing proprietary protection for EB-1020 through July 2026.
Neurovance also said that it has initiated a phase I clinical trial of EB-1020 with a new sustained-release (SR) formulation to treat adult attention deficit hyperactivity disorder (ADHD).
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 I “umbrella” study will evaluate pharmacokinetics, food effects and tolerability of a sustained-release formulation with multiple dose escalation in healthy volunteers. The trial is being conducted on behalf of Neurovance by INC Research and Nucleus Network in Australia. Results are expected during the second quarter, with plans for a phase IIa pilot study in the U.S. later this year.