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Newron Pharmaceuticals S.p.A.. (4/5/16). "Press Release: Ongoing Phase II Study of Evenamide (NW-3509) May Suggest an Alternative Approach to the Treatment of Schizophrenia". Milan.

Organisation Organisation Newron Pharmaceuticals S.p.A. (SIX: NWRN)
  Group Newron (Group)
Products Product evenamide (NW-3509)
  Product 2 clinical research
Person Person Anand, Ravi (Newron Pharmaceuticals 201103 CMO)
     


Evidence of anti-pyschotic efficacy as an add-on to antipsychotics


Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, announced today that it presented at the 5th Biennial Schizophrenia International Research Society Conference the abstract “Evenamide (NW-3509), a Putative Antipsychotic, Targets Abnormal Electrical Activity and Glutamatergic Abnormalities in Improving Psychotic Symptoms in Patients with Schizophrenia in a Phase II, Placebo-controlled Trial”.

Evenamide (NW-3509) is a new generation antipsychotic that acts through pathways that are not targeted by current treatments or other putative antipsychotics. It is associated with a functional blockade of voltage-gated sodium channels that inhibits glutamate release by reducing the firing rate of hyper-excited neurons and may normalize aberrant cortical and hippocampal activity. A Phase II, placebo-controlled study in patients with schizophrenia experiencing breakthrough symptoms while on adequate doses of risperidone or aripiprazole is ongoing, in which Evenamide is being evaluated at doses of 15-25 mg bid as add-on therapy for reducing positive symptoms and psychotic worsening.

Ravi Anand, MD, Newron’s Chief Medical Officer, stated: “Evenamide (NW-3509) has demonstrated in preclinical models that it provides inhibition of voltage-gated sodium channels without any effect on receptors, enzymes and transporters targeted by most antipsychotics and yet is active in most animal models of psychosis. Intriguingly, in animal models of psychosis, the addition of ineffective doses of both NW-3509 and typical or atypical antipsychotics, showed significant benefit. This finding, if confirmed in poorly responding patients, would suggest that the current practice of switching non-responding patients to another antipsychotic be replaced by the addition of NW-3509 to their regimen. This would avoid such issues as discontinuation effects, need to hospitalize patients, anti-dopaminergic, metabolic, and sexual side effects.”


About Newron Pharmaceuticals

Newron (SIX: NWRN), Bresso / Italy, is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain. Xadago® (Safinamide) has received marketing authorization for the treatment of Parkinson’s Disease in the European Union and Switzerland and is commercialized by Newron’s Partner Zambon. US WorldMeds holds the commercialization rights in the US. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. 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 more information

Media

Newron
Stefan Weber – CEO
Phone: +39 02 6103 46 26
E-mail: pr@newron.com

UK/Europe
Julia Phillips
FTI Consulting
Phone: +44 (0)20 3727 1000

Switzerland
Martin Meier-Pfister
IRF Communications
Phone: +41 43 244 81 40

Germany
Anne Hennecke
MC Services AG
Phone: +49 211 52925222
anne.hennecke@mc-services.eu

USA
Alison Chen
LaVoieHealthScience
Phone: +1 617 374 8800, Ext. 104
achen@lavoiehealthscience.com

Investors and Analysts

Newron
Stefan Weber – CEO
Phone: +39 02 6103 46 26
E-mail: ir@newron.com

Germany
Anne Hennecke
MC Services AG
Phone: +49 211 52925222
anne.hennecke@mc-services.eu

USA
Beth Kurth
LaVoieHealthScience
Phone: +1 617 374 8800, Ext. 109
bkurth@lavoiehealthscience.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.

   
Record changed: 2017-07-02

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