DGAP-News: Newron Pharmaceuticals S.p.A.
/ Key word(s): Study
21.01.2021 / 07:02
The issuer is solely responsible for the content of this announcement.
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.
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
Stefan Weber - CEO
+39 02 6103 46 26
Simon Conway/ Natalie Garland-Collins, FTI Consulting
+44 20 3727 1000
Martin Meier-Pfister, IRF
+41 43 244 81 40
Anne Hennecke/Caroline Bergmann, MC Services
+49 211 52925220
Paul Sagan, LaVoieHealthScience
+1 617 374 8800, Ext. 112
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.
21.01.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de