Neurovance, Inc. develops pharmaceutical preparations for the treatment of disorder of the central nervous system. The company was founded in 2011 and is based in Cambridge, Massachusetts.
43 Thorndike Street
Cambridge, MA 02141
Founded in 2011
Neurovance Announces FDA Acceptance of IND Application for EB-1020 SR and Initiates Phase 2a Study in Adult ADHD; Appoints Timothy Hsu as Chief Medical Officer
Sep 24 13
Neurovance, Inc. announced acceptance of its Investigational New Drug (IND) application for EB-1020 SR by the US Food and Drug Administration and initiation of a phase 2a pilot study in adult patients with attention deficit hyperactivity disorder (ADHD). EB-1020 SR was designed for use in all subtypes of adult ADHD and is intended to show greater efficacy than atomoxetine, the only non-stimulant currently approved for adults today. EB-1020 SR has the potential for less abuse liability than the stimulants, the leading medications used to treat adults with ADHD. Patient recruitment is now underway in the phase 2a clinical trial, and top-line results are expected in early 2014. The EB-1020-ADHD-201 trial is a US exploratory phase 2a flexible-dose study in 40 adult ADHD patients and is designed to establish the efficacy of doses ranging from 300 to 500 mg per day. It will be led by Dr. Andrew Cutler. The pilot study, the first in the US and the first in patients, follows two phase 1 studies conducted in Canada and Australia that established the safety, pharmacokinetics and tolerability of the molecule in healthy volunteers. The US ADHD market in 2012 was valued at $10.4 billion with significant prescription growth coming from the adult segment of the market. Worldwide recognition and treatment of adult ADHD are expected to rise significantly during the next decade. EB-1020 SR has the potential to treat adults with ADHD with the co-morbidities that affect the majority of adults with ADHD including depression, anxiety and even substance abuse. EB-1020 SR modulates norepinephrine (NE), dopamine (DA) and to a lesser extent, serotonin (5-HT) reuptake inhibition in a ratio of 1 to 6 to 14, respectively. EB-1020 SR has a norepinephrine profile similar to the first-generation non-stimulant atomoxetine, but unlike atomoxetine, EB-1020 SR adds moderate dopamine and serotonin neurotransmission that is intended to improve efficacy as well as to potentially impact the co-morbidities associated with ADHD. The combination of norepinephrine and dopamine reuptake inhibition is believed to improve both focus and decision-making that are impaired in ADHD. The level of dopamine activity associated with EB-1020 SR is less than that of stimulants -- an important distinction because stimulants may be addictive, leading to their designation as Schedule II controlled substances that are tightly regulated by the government. By contrast, EB-1020 SR may have a lower risk of drug abuse liability and diversion, as suggested by preclinical and clinical data to date.
Neurovance announced that Timothy Hsu, MD, has been appointed Chief Medical Officer. Dr. Hsu has more than 15 years of large pharma/biotech clinical development and medical affairs experience and over 30 years of expertise as a psychiatrist and internist. His experience covers approvals across a variety of CNS indications and all stages of drug development, including overseeing preclinical, clinical and post-approval programs, interpreting data for regulatory submissions, and leading discussions with international regulatory agencies.
Neurovance, Inc. Completes Phase 1 Clinical Trial of EB-1020
Oct 18 12
Neurovance, Inc. completed its phase 1 clinical trial of EB-1020, its norepinephrine and dopamine-preferring reuptake inhibitor, that evaluated single and multiple ascending doses in normal subjects. EB-1020 was well tolerated and demonstrated a wide therapeutic index. EB-1020 is being developed for adult ADHD due to its potent norepinephrine (NE) reuptake inhibition, combined with moderate dopamine (DA) reuptake inhibition and very modest serotonin (5-HT) reuptake inhibition. This suggests EB-1020 has a profile similar to the pharmacology of the non-stimulant atomoxetine given in combination with methylphenidate, one of the stimulants. Unlike stimulants, however, EB-1020 may have a low risk of drug abuse liability, as suggested by preclinical and clinical data.