Market Overview

Newron Initiates U.S. Phase II Trial in Patients with Schizophrenia

Share:
MILAN--(BUSINESS WIRE)--

Newron Pharmaceuticals S.p.A. ("Newron"), a research and development company focused on novel CNS and pain therapies, announced today the initiation of a U.S. Phase II study with its novel sodium channel blocker, NW-3509, in patients with schizophrenia. NW-3509 is an orally available new chemical entity that specifically targets voltage-gated sodium channels, acting with a unique mechanism of action.

The Phase II trial is designed to investigate safety and preliminary evidence of efficacy in a double-blind, placebo-controlled randomized trial. NW-3509 will be administered as add-on treatment in schizophrenic patients experiencing break-through psychotic symptoms while on stable and adequate doses of their current atypical antipsychotics. The 4-week study will be performed in a minimum of 60 patients in two U.S. study centers. Patients will be treated twice daily with 5-25 mg/day of NW-3509, or placebo. The doses to be tested in this study in patients were found to be well-tolerated in healthy subjects and were associated with plasma levels that overlapped with exposure shown to be effective in preclinical models of psychosis. Doses and study design were finalized after receiving FDA input and guidance. Study results are expected to be available in Q4 2016.

The potential benefits of NW-3509 have been demonstrated in numerous animal models predictive of efficacy in psychiatric diseases, including models of psychosis such as amphetamine-induced hyperactivity, sensorimotor gating and information processing deficits (pre-pulse inhibition impairment induced by different stimuli), mania and depression.

Ravi Anand, M.D., Ph.D., Newron's Chief Medical Officer, stated: "The addition of NW-3509 in patients not responding to their current antipsychotic treatment may improve positive symptoms. New preclinical results also indicate that NW-3509 improves social withdrawal due to Phencyclidine or PCP ("angel dust"), an important predictor of negative symptom improvement."

About Schizophrenia

Schizophrenia is a long-term mental health condition that causes a range of different psychological symptoms. It is one of the most common serious mental health conditions. About 1 in 100 people will experience schizophrenia in their lifetime, with many continuing to lead normal lives. Schizophrenia is most often diagnosed between the ages of 15 and 35. Men and women are affected equally. There is no single test for schizophrenia. It is most often diagnosed after an assessment by a mental health care professional, such as a psychiatrist. It is important that schizophrenia is diagnosed as early as possible, as the chances of recovery improve the earlier it is treated. Schizophrenia is often described in terms of positive and negative (or deficit) symptoms. Positive symptoms are those that most individuals do not normally experience but are present in people with schizophrenia. They can include delusions, disordered thoughts and speech, and tactile, auditory, visual, olfactory and gustatory hallucinations, typically regarded as manifestations of psychosis. Hallucinations are also typically related to the content of the delusional theme. Positive symptoms generally respond well to medication. Negative symptoms are deficits of normal emotional responses or of other thought processes, and are less responsive to medication. They commonly include flat expressions or little emotion, poverty of speech, inability to experience pleasure, lack of desire to form relationships, and lack of motivation. Negative symptoms appear to contribute more to poor quality of life, functional ability, and the burden on others than do positive symptoms. People with greater negative symptoms often have a history of poor adjustment before the onset of illness, and response to medication is often limited.

About NW-3509

NW-3509 is an orally available new chemical entity that specifically targets voltage-gated sodium channels. The compound modulates sustained repetitive firing, without inducing impairment of normal neuronal excitability. NW-3509 normalizes glutamate release induced by aberrant sodium channel activity. The potential benefits of NW-3509 have been demonstrated in numerous preclinical models predictive of efficacy in psychiatric diseases, including models of psychosis such as amphetamine-induced hyperactivity, sensorimotor gating and information processing deficits (pre-pulse inhibition impairment induced by different stimuli), mania and depression. Efficacy of NW-3509 has also been demonstrated in models of aggression and compulsive behavior, as well as in short- and long-term memory tests. Sub-threshold doses of NW-3509 increased the activity of inactive doses of both typical and atypical antipsychotics in models of schizophrenia, psychosis and mania. Moreover, given its neuronal stabilization properties, NW-3509 may reduce relapses and prevent or treat episodes of psychosis due to established super-sensitivity psychosis (SSP) induced by antipsychotics. As it is devoid of the risk of drug-induced movement disorders or weight gain, NW-3509 can be given in combination for extended periods of time.

About Newron Pharmaceuticals

Newron (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. Marketing authorization in the EU for Xadago® (safinamide) for the treatment of Parkinson's disease was granted by the EU Commission in February 2015, followed by the launch by Zambon in the first key EU country - Germany - in May 2015. The New Drug Application (NDA) has been accepted for review by the FDA, as reported in March 2015. In November 2015, Swissmedic has granted marketing authorization to Zambon, Newron's partner. Zambon has the rights to develop and commercialize safinamide globally, excluding Japan and other key Asian territories, where Meiji Seika has the rights to develop and commercialize the compound. Newron's additional projects are based on highly promising treatments for rare disease patients and are at various stages of clinical development. They include sarizotan for patients with Rett syndrome, for which Newron received Orphan Drug Designation in both the US and the EU, ralfinamide for patients with specific rare pain indications, and NW-3509 as potentially the first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. For additional information, please visit http://www.newron.com.

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron's ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialisation of its product candidates and reduce costs (including staff costs), (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron's anticipated future revenues, capital expenditures and financial resources, and (4) assumptions underlying any such statements. In some cases these statements and assumptions can be identified by the fact that they use words such as "will", "anticipate", "estimate", "expect", "project", "intend", "plan", "believe", "target", and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements.

By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions.

Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programmes, development activities, commercialisation plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions.

Newron does not undertake any obligation to publicly up-date or revise forward looking statements except as may be required by applicable regulations of the SIX Swiss Exchange where the shares of Newron are listed.This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

Media
Newron Pharmaceuticals
Stefan Weber, +39 02 6103 46 26
CEO
pr@newron.com
or
UK/Europe
FTI Consulting
Julia Phillips, +44 (0)20 3727 1000
or
Switzerland
IRF Communications
Martin Meier-Pfister, +41 43 244 81 40
or
Germany
MC Services AG
Anne Hennecke, +49 211 52925222
anne.hennecke@mc-services.eu
or
U.S.
LaVoieHealthScience
David Connolly, +1 617 374 8800, Ext. 108
dconnolly@lavoiehealthscience.com
or
Investors and Analysts
Newron Pharmaceuticals
Stefan Weber, +39 02 6103 46 30
CEO
ir@newron.com
or
Germany
MC Services AG
Anne Hennecke, +49 211 52925222
anne.hennecke@mc-services.eu
or
U.S.
LaVoieHealthScience
Kristina Coppola, +1 617 374-8800, Ext. 105
kcoppola@lavoiehealthscience.com

View Comments and Join the Discussion!