Newron presents encouraging interim results for evenamide in patients with treatment-resistant schizophrenia (TRS) at the 33rd CINP Hybrid Neuropsychopharmacology World Congress

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MILAN, Italy–(BUSINESS WIRE)–Newron Pharmaceuticals SpA (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on developing novel therapies for patients with diseases of the central nervous system and device (CNS), today announced encouraging interim results for the first 100 patients of its first global, international, open-label, randomized, blinded, multicenter, six-week study of evenamide as an as an adjunct to an antipsychotic in patients with moderate to severe treatment-resistant schizophrenia (TRS) who were unresponsive to current antipsychotic medications.

The results presented at the 33rd The Hybrid World Congress of Neuropsychopharmacology at the Collegium Internationale Neuro-Psychopharmacologicum (CINP), Taipei, Taiwan, shows that the addition of evenamide (7.5/15/30mg bid) improved symptoms of psychosis in patients with Chronic SRT, which resulted in a reduction of approximately 12% in the PANSS score, a CGI-S improvement of 0.7, and CGI-C scores indicating that 77% of patients responded to treatment. The first 100 patients were primarily treated with the 7.5 and 15 mg bid doses, as patients were initially randomized to receive treatment with these doses; an independent safety monitoring board reviewed the safety data of the first 50 patients who completed the trial before allowing randomization to 30 mg bid.

Ravi Anand, MD, Newron’s Chief Medical Officer, said, “We are delighted to present interim results from this study, which demonstrate the potential of evenamide as an add-on therapy to antipsychotics in patients with drug-resistant schizophrenia. treatment. The data presented today supports the potential of evenamide to improve symptoms of psychosis in patients who, despite treatment with various antipsychotics, continue to experience severe symptoms of psychosis and functional disabilities. These patients represent approximately one third of the global population of schizophrenics and therefore a significant unmet medical need. Evenamide acts by selective attenuation of abnormal glutamate release and in synergy with background antipsychotic activity. The result of this study may change the treatment of future patients with TRS when confirmed in a larger placebo-controlled study.

Newron plans to initiate a potentially pivotal, multinational, randomized, placebo-controlled study in patients with treatment-resistant schizophrenia in the first quarter of 2023, as part of its ongoing Phase II/III development plan for the evenamide.

Study design 014

This six-week, randomized, evaluator-blinded study is being conducted at multiple sites in three countries. The study will include approximately 180 TRS patients receiving a stable therapeutic dose of a single antipsychotic other than clozapine. The main objective of the study is to evaluate the safety and tolerability of evenamide administered orally at three fixed doses (7.5, 15 and 30 mg bid). Preliminary efficacy assessment, based on changes from baseline in the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Change from Baseline (CGI-C), severity of disease (CGI-S) and the Strauss-Carpenter level of functioning scale (LOF), is a secondary objective.

Patients were moderately to severely ill (CGI-S 4 to 6), with an initial PANSS total score ≥ 70 and

Conference call

Newron CEO Stefan Weber and CMO Ravi Anand will host a conference call today, June 7, at 3 p.m. CET / 9 a.m. ET.

The call is accessible via the following call numbers:

Switzerland/Europe: +41 (0) 58 310 5000

UK: +44 (0) 207 107 0613

USA: +1 (1) 631 570 5613

The presentation of this conference call as well as the summaries/videos presented at the 33rd The CINP Neuropsychopharmacology World Congress, covering the interim results of Study 014, the safety profile of evenamide and the study plan for the next potentially pivotal study with evenamide in TRS can be downloaded starting today, June 7, 7:00 a.m. CET, on the Newron website. (https://www.newron.com/investors/reports-and-presentation/year/2022#reports,-presentations-&-webcasts).

About Treatment Resistant Schizophrenia

About one-third of patients with schizophrenia, including about 15% early in the disease, show virtually no beneficial response to antipsychotics (APs), despite adequate treatment. They are diagnosed with treatment-resistant schizophrenia (TRS), operationally defined as no or insufficient symptomatic relief. despite treatment with therapeutic doses of two antipsychotics of two different chemical classes for an adequate period. Mounting evidence supports abnormalities in glutamate neurotransmission in the TRS, untargeted by current PAs, as well as normal dopaminergic synthesis, to explain the lack of benefit of most typical and atypical antipsychotics.

About evenamide

Evenamide has the potential to be the first complementary therapy for the treatment of patients with schizophrenia. The compound is a novel orally available chemical entity that specifically targets voltage-gated sodium channels. Evenamide originates from Newron’s ion channel program and has a unique mechanism of action: modulation of glutamate and blockade of voltage-gated sodium channels. 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 evidence of efficacy for evenamide in significantly improving symptoms of psychosis compared to placebo when added to two of the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia. The study also indicated that evenamide lacks an effect on any of the more than 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics. Studies involving more than 400 healthy volunteers and patients with schizophrenia met the safety target on all variables.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on developing novel therapies for patients with diseases of the central and peripheral nervous system. The company is headquartered in Bresso, near Milan, Italy. Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, United Kingdom, United States, Australia, Canada, America Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is marketed by Newron’s partner, Zambon. Supernus Pharmaceuticals owns the marketing rights in the United States. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as a potential first adjunctive therapy for the treatment of patients with symptoms of schizophrenia. For more information, visit: www.newron.com

Important Notices

This document contains forward-looking statements, including (without limitation) regarding (1) Newron’s ability to develop and expand its business, complete the development of its current product candidates, the timing of the commencement of various clinical trials and receipt of current and future data and 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) the assumptions underlying these statements. In some instances, these statements and assumptions can be identified by the use of 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, objectives, plans, future financial condition, projected revenues and costs, and outlook are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and there are risks that the predictions, forecasts, projections and other results described, assumed or implied will not be achieved. Future events and actual results could differ materially from those expressed, contemplated or underlying the forward-looking statements due to a number of important factors. These factors include (but are not limited to) (1) uncertainties in product discovery, development, or commercialization, including, but not limited to, difficulties enrolling in clinical trials, negative results clinical trials or research projects or unexpected side effects, (2) delay or inability to obtain regulatory approvals or bring products to market, (3) future acceptance of products by market, (4) loss or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of entry into future agreements collaboration and licensing, (7) litigation, (8) loss of key executives or other employees, (9) adverse publicity and media coverage, and (10) competitive, regulatory developments or changes , legislative and judicial on the market and / or the conditions general economic issues. Newron may not achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying such statements may prove to be incorrect. Investors should therefore not place undue reliance on it. There can be no assurance that the actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set forth in such forward-looking statements or underlying assumptions. Newron undertakes no obligation to publicly update or revise any forward-looking statements, except as may be required by applicable regulations of the SIX Swiss Exchange where Newron’s shares are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for 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. be it.

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