PRESS RELEASE : Newron completes enrollment of explanatory safety and efficacy study with evenamide in schizophrenia patients

DGAP-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study 
Newron completes enrollment of explanatory safety and efficacy study with evenamide in schizophrenia patients 
2021-01-21 / 07:02 
The issuer is solely responsible for the content of this announcement. 
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Newron completes enrollment of explanatory safety and efficacy study with evenamide in schizophrenia patients 
Final study data intended to support the initiation of Newron's planned phase III pivotal trial program for evenamide 
 
Milan, Italy and Morristown, NJ, USA, January 21, 2021 - Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: 
NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the 
central and peripheral nervous system, today announced the completion of enrollment for its explanatory study 008 with 
evenamide in patients with schizophrenia. 
Results from the four-week, randomized, double-blind placebo-controlled study are expected in March 2021. Explanatory 
study 008 is designed to evaluate the safety, tolerability, EEG effects, and preliminary efficacy of two fixed doses of 
evenamide (7.5 mg and 15 mg BID) in outpatients with chronic schizophrenia receiving treatment with one of the leading 
second-generation atypical antipsychotics. Enrollment to the study has been completed with 138 patients randomized to 
treatment with placebo, 7.5 mg BID, or 15 mg BID of evenamide at study centers in the United States and India. 
The US Food and Drug Administration (FDA) requested that Newron complete additional short-term explanatory studies in 
rats and humans to address concerns from a study of evenamide in rats, and CNS events observed following high-dose 
administration of evenamide in dogs. 
The data from study 008 will be a key component in the package of information to be submitted to the FDA to support the 
approval of the initiation of Newron's planned phase III pivotal trial program for evenamide. Preclinical results 
confirming absence of toxicity have already been submitted to the FDA to support this package. 
The proposed phase III clinical trial program with evenamide targets patients with schizophrenia experiencing worsening 
of psychosis on atypical antipsychotics, and treatment-resistant patients not responding to clozapine. Clozapine is the 
only antipsychotic approved worldwide for treatment-resistant schizophrenia. 
Newron is currently evaluating potential options for partnering/co-developing the further development of evenamide. 
 
About evenamide 
Evenamide has the potential to be first add-on therapy for the treatment of patients with positive symptoms of 
schizophrenia. The compound is an orally available New Chemical Entity that specifically targets voltage-gated sodium 
channels for the treatment of schizophrenia. Evenamide originates from Newron's ion channel program and has a unique 
mechanism of action: glutamate modulation and voltage-gated sodium channel blockade. Evenamide modulates sustained 
repetitive firing, without inducing impairment of normal neuronal excitability. It normalizes glutamate release induced 
by aberrant sodium channel activity. In a Phase IIa clinical study, Newron demonstrated evenamide's evidence of 
efficacy in significantly improving symptoms of psychosis compared with placebo when added to two of the most commonly 
prescribed atypical antipsychotics in patients with chronic schizophrenia. The study also indicated that evenamide is 
devoid of an effect on any of the over 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics. 
 
About Newron Pharmaceuticals 
Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for 
patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, 
Italy. Xadago^(R)/safinamide has received marketing authorization for the treatment of Parkinson's disease in the 
European Union, Switzerland, the USA, Australia, Canada, Brazil, Colombia, the United Arab Emirates, Japan and South 
Korea, and is commercialized by Newron's Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in 
the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. 
Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive 
symptoms of schizophrenia. For more information, please visit: www.newron.com 
For more information 
Newron 
Stefan Weber - CEO 
[phone] 
[e-mail] 
UK/Europe 
Simon Conway/ Natalie Garland-Collins, FTI Consulting 
[phone] 
[e-mail] 
Switzerland 
Martin Meier-Pfister, IRF 
[phone] 
[e-mail] 
Germany/Europe 
Anne Hennecke/Caroline Bergmann, MC Services 
[phone] 
[e-mail] 
USA 
Paul Sagan, LaVoieHealthScience 
[phone], Ext. 112 
[e-mail] 
 
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, the timing of 
commencement of various clinical trials and receipt of data and current and future collaborations for the development 
and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, 
(3) Newron's 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 difficulties in enrolling clinical trials, 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 programs, development activities, commercialization 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. 
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