MILAN--(BUSINESS WIRE)--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.
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.