Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria
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EQS-News: Newron Pharmaceuticals S.p.A.
/ Key word(s): Conference/Study results
Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria 40% of patients no longer met TRS severity criteria Company presented data from study in treatment resistant schizophrenia (TRS) confirming therapeutic durability and efficacy at the 36th ECNP Congress in Barcelona Data after six months of treatment with evenamide demonstrate significant, clinically important, sustained and long-lasting improvement on PANSS total, CGI-S and Levels of Functioning (LOF) Almost all patients benefited from evenamide, with none showing psychotic worsening during the study Results further validate the use of a selective glutamate inhibitor as an adjunct to antipsychotics in patients with TRS Company prepares for initiation of potentially pivotal, Phase III, 1-year, randomized, double-blind, placebo-controlled trial to confirm these results Milan, Italy, October 9, 12:35 pm 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 (CNS), today at 12:35 pm CEST presented new data from study 014/015 evaluating its investigational drug evenamide for the management of treatment resistant schizophrenia (TRS). The data, which demonstrated that evenamide treatment was associated with an increasing, sustained, and clinically significant improvement of symptoms were presented at the 36th European Clinical Neuropsychopharmacology Congress (ECNP) in Barcelona, Spain. Results to date show that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events, or drop out due to intolerance, and no pattern of central nervous system abnormalities. 95% of patients completed six weeks of treatment, 94% of the completers chose to continue with evenamide treatment into the long-term extension study (Study 015) and 92% of them reached six months of treatment. Key findings and conclusions at six months (full study population):
These results have expedited the design of a potentially pivotal, Phase III randomized, double-blind, placebo-controlled study of two doses of evenamide (15 and 30 mg bid) as an add-on treatment in patients with TRS. Ravi Anand, Newron’s Chief Medical Officer, said: “These highly encouraging results from study 014/015 presented today demonstrate the potential benefits of evenamide and its unique glutamatergic mechanism of action. The findings show that the addition of this glutamate modulation to first- and second-generation antipsychotics in patients with TRS potentiates their effects on dopamine dysfunction and can potentially produce a beneficial antipsychotic response.” What is remarkable about the effect of evenamide in this study is that treatment benefits continue to accrue overtime, and many patients who do not respond early achieve clinically important benefits later. Importantly, over the course of the study period, we found that no patients relapsed or experienced worsened psychosis, and a significant portion of patients improved to the point that they no longer met the criteria to enrol in the study to begin with. Following these encouraging results, which have been assessed by our international advisory committee, we are preparing to initiate a potentially pivotal, Phase III, multinational, randomized, double-blind, placebo-controlled trial in patients with TRS and are confident that the results from that study will endorse the use of evenamide as an adjunct treatment to any other antipsychotic as a new therapeutic strategy for TRS.” Efficacy and safety results from all 161 patients at the six-week primary endpoint of study 014 were announced in March 2023. All posters presented are available at Newron’s website. About treatment-resistant schizophrenia (TRS) About study 014/015 About evenamide About Newron Pharmaceuticals For more information, please contact: Newron UK/Europe Switzerland Germany/Europe USA 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 update 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.
09.10.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG. |
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