Latest news with #Newron
Business Wire
12-05-2025
- Business
- Business Wire
Newron Announces Approval for Pivotal Phase III ENIGMA-TRS Program With Evenamide as Add-on Therapy in Patients With Treatment-resistant Schizophrenia (TRS)
MILAN & MORRISTOWN, N.J.--(BUSINESS WIRE)--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 approval for its pivotal ENIGMA-TRS Phase III development program evaluating evenamide as an add-on therapy to current antipsychotics, including clozapine, in patients with treatment-resistant schizophrenia (TRS). Newron today announced the approval for its pivotal ENIGMA-TRS Phase III development program evaluating evenamide as an add-on therapy to current antipsychotics, including clozapine, in patients with treatment-resistant schizophrenia (TRS). Share The ENIGMA-TRS Phase III development program consists of two pivotal studies, ENIGMA-TRS 1 and ENIGMA-TRS 2. The two studies are expected to meet the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) specified regulatory requirements for submission of the registration dossier for evenamide in major territories, including the US and Europe. ENIGMA-TRS 1 is an international, 52-week, randomized, double-blind, placebo-controlled Phase III study evaluating the efficacy, tolerability, and safety of the 15mg BID and 30mg BID therapeutic doses of evenamide compared to placebo. Patients on second-generation anti-psychotics (SGAs), including clozapine, will meet Treatment Response and Resistance Psychosis (TRRIP) international consensus criteria for TRS. ENIGMA-TRS 1 will enroll at least 600 patients at study centers in Europe, Asia, Latin America and Canada. Patients will undergo a 42-day screening period, during which their TRS diagnosis, antipsychotic plasma levels (background medication), and conformance to protocol selection criteria will be evaluated by an Independent Eligibility Assessment Committee (IEAC) of three leading international schizophrenia experts. The primary assessment of efficacy and safety will be performed 12 weeks after randomization to treatment. The study will continue double-blind and placebo-controlled until the 52-week (i.e. one year) time point. Enrolment to the study will start imminently. The 12-week results from the study are expected in Q4 2026. ENIGMA-TRS 2, approved by the US Food and Drug Administration (FDA), will be performed at centers in the US and selected additional countries and will include at least 400 patients in a 12-week, randomized, double-blind, placebo-controlled Phase III study, designed to evaluate the efficacy, tolerability, and safety of the 15mg BID dose of evenamide. Patients will meet selection criteria and be reviewed by the above-mentioned IEAC. The analysis for determination of efficacy and safety will be performed after patients complete 12 weeks of participation in the trial. US investigational centers are expected to initiate the study within the next three months. Stephen Marder, MD, Distinguished Professor of Psychiatry, Semel Institute of Neuroscience & Human Behavior, and Director, Section on Psychosis, UCLA Neuropsychiatric Institute, commented: 'The imminent initiation of ENIGMA-TRS 1 study of evenamide is a significant milestone in the search for new medications to treat this devastating condition. Evenamide's modulation of glutamate, good tolerability, and efficacy in studies performed to date, both in patients who are poor responders or treatment resistant to SGAs, suggests its therapeutic potential in patients with TRS. The field eagerly looks forward for results from this landmark trial.' Jean-Pierre Lindenmayer, MD, Director of Research, Psychopharmacology Research Unit - Nathan Kline Institute for Psychiatric Research at Manhattan Psychiatric Center, added: 'Evenamide's selectivity for sodium channels and consequent modulation of glutamate, the demonstration of its efficacy in multiple animal models of psychosis as well as the MAM model of neurodevelopmental abnormalities, suggests promising results in patients with TRS. Completed studies in inadequate responders to SGAs and the results of a one-year study in patients with TRS predict therapeutic benefit of evenamide in TRS patients. Evenamide has the potential to fill a wide gap in our treatment for patients with incomplete response to SGAs, including clozapine. I look forward to participating to the ENIGMA-TRS 2 trial as a study center.' Ravi Anand, MD, Chief Medical Officer of Newron, stated: 'Newron greatly appreciates the regulatory approval of the ENIGMA-TRS trials. The positive results of evenamide observed in clinical studies and demonstrated in disease models have led to high enthusiasm in investigators to participate in this landmark program.' The Phase III ENIGMA-TRS clinical trials are part of Newron's development program for evenamide, targeting patients with schizophrenia experiencing worsening of psychosis on therapeutic doses of current antipsychotics, as well as treatment-resistant patients, which together account for the vast majority of patients suffering from schizophrenia. Results from previous Phase II (study 014/015) and Phase III (study 008A) studies have demonstrated evenamide's significant and increasing efficacy as an add-on therapy on multiple measures of psychopathology in patients with TRS and inadequate responders, respectively. These results also confirmed a favorable safety and tolerability profile, adding to the growing evidence that evenamide's glutamatergic inhibition mechanism of action offers an innovative therapeutic option to schizophrenia patients who are not benefiting from current antipsychotic treatments. Newron has entered into licensing agreements with EA Pharma, a subsidiary of Eisai, in Japan and other designated territories, and with Myung In Pharm in South Korea, to develop, manufacture and commercialize evenamide in the respective territories. Under the terms of the agreements, Newron will receive up to a maximum total of EUR 117 million, including an upfront payment of EUR 44 million, financial contributions to the Phase III ENIGMA-TRS program, milestone payments, and tiered royalties up to a double-digit percentage of net sales for evenamide, from EA Pharma; Myung In Pharm will contribute 10% of the total patient population to be enrolled into Newron's upcoming Phase III ENIGMA-TRS trial and cover the costs related to this population. Newron is actively exploring additional partnerships for the global development and commercialization of evenamide. About schizophrenia Approximately 25 million people worldwide are affected by schizophrenia. Despite more than 60 different types of atypical and typical antipsychotics used to treat schizophrenia globally, a considerable number of patients remain severely ill or resistant to treatment. Overall, 30-50% of patients do not respond to the available medications and are defined as treatment resistant. In addition to the patients with treatment-resistant schizophrenia (TRS), another 20-30% are described as 'poor responders to anti-psychotic medication', even if not meeting the criteria for TRS. New findings indicate that patients with TRS have abnormalities in the glutamatergic system, but not in dopaminergic transmission, so there is a significant unmet medical need for treatments with a glutamatergic mechanism of action, efficacious both in TRS patients and in those who are poor responders to the current treatments. About evenamide Evenamide is the first new chemical entity that has demonstrated significant benefits in this difficult-to-treat patient population, as seen in the potentially pivotal Phase III study 008A trial, as an add-on treatment to second generation anti-psychotics including clozapine, in 291 poorly responding patients with chronic schizophrenia. The primary endpoint, the Positive and Negative Syndrome Scale (PANSS) 1, and the key secondary endpoint, the Clinical Global Impressions Scale – Severity (CGI-S), were met and showed statistical significance compared to placebo. Importantly, evenamide treatment was associated with statistically significant increases in the proportion of patients who experienced 'clinically meaningful benefit' on the outcome variables. Evenamide was extremely well tolerated, without any of the usual side effects of available anti-psychotics. 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. Headquartered in Bresso, near Milan, Italy, Newron is advancing its lead compound, evenamide, a first-in-class glutamate modulator, which has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently in Phase III development and clinical trial results to date demonstrate the benefits of this drug candidate in the TRS patient population, with significant improvements across key efficacy measures increasing over time, as well as a favourable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron has a proven track record in bringing CNS therapies to market. Its Parkinson's disease treatment, Xadago® (safinamide), is approved in over 20 markets, including the USA, UK, EU, Switzerland, and Japan, and commercialized in partnerships with Zambon and Meiji Seika. For more information, please visit: 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 update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock 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. ______________________________ 1 Positive and Negative Syndrome Scale (PANSS) is widely used in clinical trials of schizophrenia and is considered the 'gold standard' for assessment of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017:
Associated Press
24-03-2025
- Business
- Associated Press
Newron proposes renowned biopharma company founder and entrepreneur Dr. Chris Martin for election as Independent Chairman
MILAN & MORRISTOWN, N.J.--(BUSINESS WIRE)--Mar 24, 2025-- Newron Pharmaceuticals S.p.A. ('Newron') (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for diseases of the central and peripheral nervous system, today announced that its Board of Directors has identified Chris Martin, DPhil, as a potential Independent Non-Executive Director and Chairman of the Board and will propose him for election at Newron's upcoming Annual General Meeting (AGM), to be held on April 23, 2025, in Bresso (Mi), Italy. Martin is an accomplished public and private company director with deep expertise in commercial drug development and a proven track record in founding and leading successful biopharma companies. He is expected to succeed Ulrich Köstlin, who has served as Chairman of the Board since 2013. Köstlin will end his board service following the completion of this year's AGM. Dr. Chris Martin is a recognized leader in the biopharma industry who has taken therapeutic technology from the lab bench through to regulatory approval and global market sales. Over his career, he has raised more than $1.4 billion on the capital markets to support the development of his companies. He was instrumental in co-founding ADC Therapeutics in 2012 and served as its CEO from its inception until 2022. Under his tenure, the Swiss-based ADC Therapeutics grew from a private biotech start-up to a New York Stock Exchange listed leader in the field of antibody-drug conjugates (ADC) with products marketed worldwide. He co-founded and was the CEO of Spirogen Ltd, an innovator of ADC payload technology, which was subsequently sold to AstraZeneca for a total of up to $440 million. Currently chairing the boards of MyricxBio, Tagworks, Tokamak Energy Ltd. and serving on the boards of Osivax SAS, Solcom Ltd. and Senya therapeutics (all private companies), Chris Martin holds a bachelor's degree in chemical engineering from Aston University, a DPhil in Engineering Science from the University of Oxford, and an MBA from IMD Business School. He is a British citizen and lives in Switzerland. ' Chris has successfully guided the development of blockbuster therapies from discovery to approval and commercialization,' said Ulrich Köstlin, Chairman of the Board of Directors of Newron. ' I am confident his expertise and vision will be invaluable as we advance our Phase III schizophrenia asset, evenamide, and I know he shares our excitement for its potential.' ' Newron's future is bright and in the best of hands,' continued Köstlin. ' With that assurance, I am gratified to be able to announce today my intention to retire, effective after the upcoming AGM. I am proud of my fellow directors, our CEO Stefan Weber, and our outstanding management team who have led Newron to renewed strength and promise. ' ' I am honored and excited to be the proposed candidate for the Chairman of the Board during this important time for Newron,' said Chris Martin, DPhil. 'I look forward to collaborating with the executive team and my fellow board members to advance Newron's strategy and help bring life-changing therapies to patients worldwide.' ' We are thrilled to welcome Chris to Newron. His experience and insights will be of enormous value as we build upon our progress in the coming years,' said Stefan Weber, CEO and Executive Director of Newron. 'I also want to express my sincere thanks to Ulrich for his many years of board service and stewardship and his unwavering support in the challenging environment in which we operate, all of which has been of great value to Newron and its shareholders, and to me personally as CEO. On behalf of the entire team at Newron, we wish him all the best in his well-earned retirement.' Martin would be the third Independent Non-Executive Director nominated within the last 24 months to Newron's Board, which now constitutes the majority of its five Non-Executive Directors. About the 2025 Ordinary and Extraordinary Annual General Meeting Newron's next Ordinary and Extraordinary Annual General Meeting (AGM and EGM) of Shareholders will take place on April 23, 2025. The full AGM and EGM agenda will be published for shareholders' review at the beginning of April, 2025 and will be available on the Company's website here, together with all the necessary information to register and attend the meeting, in addition to all documents connected with the agenda as per applicable laws and regulations. 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. 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. Headquartered in Bresso, near Milan, Italy, Newron is advancing its lead compound, evenamide, a first-in-class glutamate modulator, which has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently in Phase III development and clinical trial results to date demonstrate the benefits of this drug candidate in the TRS patient population, with significant improvements across key efficacy measures increasing over time, as well as a favourable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron has a proven track record in bringing CNS therapies to market. Its Parkinson's disease treatment, Xadago ® (safinamide), is approved in over 20 markets, including the USA, UK, EU, Switzerland, and Japan, and commercialized in partnerships with Zambon and Meiji Seika. For more information, please visit: . Stefan Weber – CEO +39 02 6103 46 26 UK/Europa Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting +44 20 3727 1000 [email protected] Switzerland Valentin Handschin, IRF +41 43 244 81 54 [email protected] Germany/Europa Anne Hennecke / Maximilian Schur, MC Services +49 211 52925227 [email protected] USA Paul Sagan, LaVoieHealthScience +1 617 865 0041 [email protected] KEYWORD: EUROPE UNITED STATES ITALY NORTH AMERICA NEW JERSEY SOURCE: Newron Pharmaceuticals S.p.A. Copyright Business Wire 2025. PUB: 03/24/2025 10:45 AM/DISC: 03/24/2025 10:46 AM
Yahoo
24-03-2025
- Business
- Yahoo
Newron proposes renowned biopharma company founder and entrepreneur Dr. Chris Martin for election as Independent Chairman
Expected to succeed Dr. Ulrich Köstlin who has notified Newron of his intention to retire after 12 years of service as Chairman of its Board of Directors, effective following completion of this year's AGM Chris Martin, former CEO of ADC Therapeutics, will be proposed for election as Independent Non-Executive Director and new Chairman of the Board of Directors at Newron's upcoming AGM Ad hoc announcement pursuant to Art. 53 LR MILAN & MORRISTOWN, N.J., March 24, 2025--(BUSINESS WIRE)--Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for diseases of the central and peripheral nervous system, today announced that its Board of Directors has identified Chris Martin, DPhil, as a potential Independent Non-Executive Director and Chairman of the Board and will propose him for election at Newron's upcoming Annual General Meeting (AGM), to be held on April 23, 2025, in Bresso (Mi), Italy. Martin is an accomplished public and private company director with deep expertise in commercial drug development and a proven track record in founding and leading successful biopharma companies. He is expected to succeed Ulrich Köstlin, who has served as Chairman of the Board since 2013. Köstlin will end his board service following the completion of this year's AGM. Dr. Chris Martin is a recognized leader in the biopharma industry who has taken therapeutic technology from the lab bench through to regulatory approval and global market sales. Over his career, he has raised more than $1.4 billion on the capital markets to support the development of his companies. He was instrumental in co-founding ADC Therapeutics in 2012 and served as its CEO from its inception until 2022. Under his tenure, the Swiss-based ADC Therapeutics grew from a private biotech start-up to a New York Stock Exchange listed leader in the field of antibody-drug conjugates (ADC) with products marketed worldwide. He co-founded and was the CEO of Spirogen Ltd, an innovator of ADC payload technology, which was subsequently sold to AstraZeneca for a total of up to $440 million. Currently chairing the boards of MyricxBio, Tagworks, Tokamak Energy Ltd. and serving on the boards of Osivax SAS, Solcom Ltd. and Senya therapeutics (all private companies), Chris Martin holds a bachelor's degree in chemical engineering from Aston University, a DPhil in Engineering Science from the University of Oxford, and an MBA from IMD Business School. He is a British citizen and lives in Switzerland. "Chris has successfully guided the development of blockbuster therapies from discovery to approval and commercialization," said Ulrich Köstlin, Chairman of the Board of Directors of Newron. "I am confident his expertise and vision will be invaluable as we advance our Phase III schizophrenia asset, evenamide, and I know he shares our excitement for its potential." "Newron's future is bright and in the best of hands," continued Köstlin. "With that assurance, I am gratified to be able to announce today my intention to retire, effective after the upcoming AGM. I am proud of my fellow directors, our CEO Stefan Weber, and our outstanding management team who have led Newron to renewed strength and promise." "I am honored and excited to be the proposed candidate for the Chairman of the Board during this important time for Newron," said Chris Martin, DPhil. "I look forward to collaborating with the executive team and my fellow board members to advance Newron's strategy and help bring life-changing therapies to patients worldwide." "We are thrilled to welcome Chris to Newron. His experience and insights will be of enormous value as we build upon our progress in the coming years," said Stefan Weber, CEO and Executive Director of Newron. "I also want to express my sincere thanks to Ulrich for his many years of board service and stewardship and his unwavering support in the challenging environment in which we operate, all of which has been of great value to Newron and its shareholders, and to me personally as CEO. On behalf of the entire team at Newron, we wish him all the best in his well-earned retirement." Martin would be the third Independent Non-Executive Director nominated within the last 24 months to Newron's Board, which now constitutes the majority of its five Non-Executive Directors. About the 2025 Ordinary and Extraordinary Annual General MeetingNewron's next Ordinary and Extraordinary Annual General Meeting (AGM and EGM) of Shareholders will take place on April 23, 2025. The full AGM and EGM agenda will be published for shareholders' review at the beginning of April, 2025 and will be available on the Company's website here, together with all the necessary information to register and attend the meeting, in addition to all documents connected with the agenda as per applicable laws and regulations. About Newron PharmaceuticalsNewron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on developing novel therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso, near Milan, Italy, Newron is advancing its lead compound, evenamide, a first-in-class glutamate modulator, which has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently in Phase III development and clinical trial results to date demonstrate the benefits of this drug candidate in the TRS patient population, with significant improvements across key efficacy measures increasing over time, as well as a favourable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron has a proven track record in bringing CNS therapies to market. Its Parkinson's disease treatment, Xadago® (safinamide), is approved in over 20 markets, including the USA, UK, EU, Switzerland, and Japan, and commercialized in partnerships with Zambon and Meiji Seika. For more information, please visit: View source version on Contacts Newron Stefan Weber – CEO+39 02 6103 46 26pr@ UK/Europa Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting+44 20 3727 1000SCnewron@ Switzerland Valentin Handschin, IRF+41 43 244 81 54handschin@ Germany/Europa Anne Hennecke / Maximilian Schur, MC Services+49 211 52925227newron@ USA Paul Sagan, LaVoieHealthScience+1 617 865 0041psagan@ Sign in to access your portfolio
Yahoo
11-03-2025
- Business
- Yahoo
Newron Pharmaceuticals to Participate in a Fireside Chat at the 37th Annual ROTH Conference
MILAN, Italy & MORRISTOWN, N.J., March 11, 2025--(BUSINESS WIRE)--Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for diseases of the central and peripheral nervous system, today announced that Stefan Weber, CEO, will participate in a fireside chat at the 37th Annual ROTH Conference on Monday, March 17 at 11:30 a.m. PDT. A live audio webcast of the fireside chat can be accessed on the ROTH Conference website here. 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. Headquartered in Bresso, near Milan, Italy, Newron is advancing its lead compound, evenamide, a first-in-class glutamate modulator, which has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently in Phase III development and clinical trial results to date demonstrate the benefits of this drug candidate in the TRS patient population, with significant improvements across key efficacy measures increasing over time, as well as a favourable safety profile, which is uncommon for available first- and second-generation antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron has a proven track record in bringing CNS therapies to market. Its Parkinson's disease treatment, Xadago® (safinamide), is approved in over 20 markets, including the USA, UK, EU, Switzerland, and Japan, and commercialized in partnerships with Zambon and Meiji Seika. For more information, please visit: View source version on Contacts For more information, please contact: Newron Stefan Weber – CEO+39 02 6103 46 26pr@ UK/Europa Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting+44 20 3727 1000SCnewron@ Switzerland Valentin Handschin, IRF+41 43 244 81 54handschin@ Germany/Europa Anne Hennecke / Maximilian Schur, MC Services+49 211 52925227newron@ USA Paul Sagan, LaVoieHealthScience+1 617 374 8800, Ext. 112psagan@
