May 24, 2016 2:03 PM ET

Pharmaceuticals

Company Overview of Neurovance, Inc.

Company Overview

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

Suite S1-3

Cambridge, MA 02141

United States

Founded in 2011

Phone:

617-758-0300

Key Executives for Neurovance, Inc.

Chief Executive Officer, President and Director
Executive Chairman
Age: 52
Chief Medical Officer
Vice President of Clinical Development
Compensation as of Fiscal Year 2015.

Neurovance, Inc. Key Developments

Neurovance, Inc. Appoints Jeff Bailey as Executive Chairman of Board of Directors

Neurovance, Inc. announced the appointment of Jeff Bailey as Executive Chairman of the Company's Board of Directors. He brings nearly 30 years of experience from a wide range of earlier leadership positions. Mr. Bailey had previously been President and Chief Executive Officer of Lantheus Medical Imaging Inc. until August, 2015. Earlier, he served as Chief Operating Officer of Fougera Pharmaceuticals and Chief Commercial Officer for King Pharmaceuticals. Mr. Bailey will join current board members Campbell Murray, M.D. from Novartis Venture Funds (formerly the Chair of the Neurovance board), Paul Weiss, Ph.D. from Venture Investors, Daniel R. Omstead, Ph.D. from Tekla Capital Management, Brigitte Smith, M.B.A. from GBS Venture Partners, Timothy Barberich, and Anthony McKinney, Neurovance President and CEO.

Neurovance Announces Series of Three Clinical Trials to Support Advanced Development of Centanafadine (CTN) in Adult ADHD

Neurovance, Inc. announced a series of three clinical trials to advance the development of centanafadine (CTN), a triple reuptake inhibitor for the treatment of adults with ADHD and related co-morbidities. The series of three trials include a phase 1 imaging study, a phase 2 efficacy trial in adult ADHD and a phase 1 pharmacokinetics (PK) study evaluating several once-daily formulations. Together these three studies will measure brain transporter occupancy, clinical efficacy in ADHD, onset and duration of action, guidance on optimal dosing and formulation selection. These trials will lay the groundwork for phase 2b/3a trials as well as other trials using a once-daily formulation beginning in 2016. CTN is a triple reuptake inhibitor that modulates the activity of norepinephrine (NE), dopamine (DA) and serotonin (5-HT) for the treatment of ADHD. Previous studies have demonstrated CTN has efficacy in ADHD approaching that of stimulants but with reduced potential for abuse compared to two currently available stimulants. The principal study in this trio, intended to establish the efficacy and safety of twice-daily CTN in ADHD patients, is a phase 2 double-blind, randomized, placebo-controlled three-week crossover trial. The primary endpoint is the change from baseline on the ADHD-Rating Scale, one of the standard instruments used in ADHD registration trials. A phase 2a pilot study has previously demonstrated the onset of action may be within one week with CTN and there may be sustained activity following discontinuation. This finding suggests that treatment with CTN may be less sensitive to missed doses with the potential of maintenance of response after discontinuation. The study is taking place at several US centers of excellence for ADHD studies. The results of the phase 2 ADHD efficacy trial will be assessed alongside an ongoing NE, DA and 5-HT transporter occupancy study with SPECT imaging and using active comparators versus CTN SR. Top-line data for both trials are expected in the first quarter 2016. These results in turn will provide the baseline for a third study, a phase 1 pharmacokinetics study designed to help select the preferred, among three extended-release (XR) formulation candidates for advanced development. This trial is expected to start in the first quarter of 2016.

Neurovance, Inc. Announces Top-Line Results from a Human Abuse Liability Study in Recreational Stimulant Users

Neurovance, Inc. announced top-line results from a human abuse liability (HAL) study in recreational stimulant users. Centanafadine (CTN) sustained-release (SR) is a novel triple reuptake inhibitor being developed for the treatment of adults with ADHD and has shown favorable efficacy with good tolerability in a phase 2a patient study. Centanafadine works by modulating the activity of norepinephrine, dopamine and serotonin, three neurotransmitters known to be relevant in patients with ADHD. The results of the HAL study suggest that CTN has reduced abuse potential compared to the Schedule II stimulants which are commonly used for ADHD, though restricted due to risk of abuse and diversion. In the HAL study, treatment with CTN immediate release (IR) at high doses resulted in a markedly different profile than comparators (vs. Vyvanse or d-amphetamine or placebo) with acute onset of aversive effects in the majority of subjects including nausea, vomiting and dysphoria. Almost two hours after administration of CTN, test subjects reported liking at about two-thirds of the magnitude of amphetamines, a finding likely indicative of dopamine activity. However, unlike amphetamines that provided an immediate positive experience, subjects receiving CTN experienced negative effects before reaching this point. This early aversive profile of CTN is unique, inherent to the norepinephrine and serotonin pharmacology of the molecule, and is believed likely to deter abuse if the SR is misused. Full results of the HAL study were presented at the 53rd Annual Meeting of the American College of Neuropsychopharmacology in Phoenix on December 10th. The HAL study was a five-arm crossover study designed to evaluate the abuse liability potential for CTN IR among subjects known to use recreational stimulants. Single doses of 400 or 800 mg IR were tested alongside Schedule II comparators d-amphetamine or lisdexamfetamine (Vyvanse), or placebo. The findings showed that CTN IR, at a dose sufficient to elicit a measurable reward, would also result in negative effects. For example, subjects said they would significantly prefer to take d-amphetamine as compared to CTN 800 mg.

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