DGAP-News: Newron Initiates First Potentially Pivotal Study with Evenamide in Patients with Schizophrenia

Newron Initiates First Potentially Pivotal Study with Evenamide in Patients with Schizophrenia

• Evenamide has the potential to be the first add-on therapy for patients with positive symptoms of schizophrenia
• Four-week, double-blind, placebo-controlled study to evaluate safety and efficacy of therapeutic dose (30mg BID)
• Minimum of 200 patients to be enrolled at study centers in Europe, Asia and Latin America
• Evenamide's glutamatergic inhibition mechanism of action offers an innovative therapeutic option to patients not benefitting from current antipsychotic treatments

Milan, Italy and Morristown, NJ, USA, September 6, 2021, 07:00 am CEST - 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 initiation of Study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia.

Study 008A, a four-week, randomized, double-blind placebo-controlled international study, is designed to evaluate the efficacy, tolerability, and safety (including effects on the electroencephalogram (EEG)) of the 30mg BID therapeutic dose of evenamide in patients with chronic schizophrenia, currently being treated with a second-generation antipsychotic. Newron plans to randomize at least 200 patients in study centers in Europe, Asia and Latin America. Results from the study are expected by Q4 2022.

This study is part of Newron's Phase III evenamide clinical trial program that targets patients with schizophrenia experiencing worsening of psychosis on therapeutic doses of atypical antipsychotics, as well as treatment-resistant patients.

Ravi Anand, MD, Newron's CMO, commented: "Evenamide has been shown to be safe in studies treating more than 300 healthy volunteers and patients at doses of up to 60mg. Study 008A will now evaluate the efficacy, tolerability and safety of the therapeutic dose of 30mg BID. If successful, Newron believes the study would qualify as the first adequate and well-controlled (pivotal) study with evenamide in patients with schizophrenia who are inadequate responders to antipsychotics. Evenamide would currently be the first add-on therapy approved for the treatment of patients with positive symptoms of schizophrenia, and its unique glutamatergic inhibition mechanism of action offers a truly innovative therapeutic option to those patients who are not benefitting from their current antipsychotics."

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. Additional studies in about 200 healthy volunteers and patients with schizophrenia have met the objective of safety on all variables.

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 UK, the USA, Australia, Canada, Brazil, Colombia, Israel, 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 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

+39 02 6103 46 26
[email protected]

UK/Europe

Simon Conway/ Natalie Garland-Collins, FTI Consulting

+44 (0)20 3727 1000
[email protected]

Switzerland

Valentin Handschin, IRF Reputation

+41 43 244 81 54
[email protected]

Germany/Europe

Anne Hennecke/Caroline Bergmann, MC Services

+49 211 52925220
[email protected]

USA

Paul Sagan, LaVoieHealthScience

+1 617 374 8800, Ext. 112
[email protected]

 

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.