GNT Pharma Announces Positive Top-Line Results in a Phase II Study of Nelonemdaz for Acute Ischemic Stroke Patients Treated With Endovascular Thrombectomy
GNT Pharma Inc. today reports positive top-line results from a phase II, double-blind, randomized, placebo-controlled, multi-center study assessing the safety and efficacy of nelonemdaz in acute ischemic stroke patients treated with endovascular thrombectomy within 8 hours of symptom onset (SONIC). In this study, the addition of nelonemdaz to surgical blood clot removal improved a patient’s chances of returning to functional independence 90 days later.
Nelonemdaz is a moderate NR2B-selective N-methyl d-aspartate (NMDA) receptor antagonist and potent spin trapper that reduces NMDA receptor-mediated excitotoxicity and oxidative stress, two major routes of brain cell death leading to disability and death after stroke. Nelonemdaz previously showed better efficacy and a longer therapeutic time window than subtype-unselective NMDA antagonists or antioxidants alone in 5 animal models of stroke. Its safety and tolerability in humans has been established in two earlier phase I studies conducted in 165 healthy young and elderly volunteers in the US and China.
SONIC enrolled 209 moderate to severe ischemic stroke patients (NIH Stroke Scale of 8 or higher) at 7 university stroke centers in South Korea. Patients received a 1st infusion of placebo, 500 mg nelonemdaz (low dose group), or 750 mg nelonemdaz (high dose group) prior to thrombectomy. Low dose and high dose groups then received 9 follow-up infusions of 250 mg and 500 mg nelonemdaz, respectively, at 12 hour intervals. The primary outcome was the fraction of patients with good functional outcome (no more than slight disability, able to look after own affairs without assistance) 90 days later, defined as a score of 0-2 on the modified Rankin Scale (mRS), the most widely used outcome measure in stroke studies. In the low dose nelomendaz group, 33 of 55 patients (60.0%) group achieved good functional outcome, and in the high dose nelomendaz group, 31 of 49 patients (64.6%) achieved good functional outcome, compared to 25 of 49 patients (51.0%) in the placebo group. The fraction of patients achieving near-complete recovery (mRS score 0) was markedly increased in nelonemdaz-treated groups, with 23.6% of the low dose group and 33.3% of the high dose group achieving no significant disability 90 days later, compared to only 8.2% of the placebo group. No serious adverse events of nelonemdaz were observed.
“Compared to placebo, administration of nelonemdaz increased the chances of achieving a good functional outcome by more than 20% in moderate to severe ischemic stroke patients who received endovascular thrombectomy”, said Dr. Byoung Joo Gwag, CEO and founder of GNT Pharma and inventor of nelonemdaz. “And it more than tripled chances of achieving a near-complete recovery. Over the last 3 decades, many NMDA antagonists and antioxidant drugs have failed in clinical stroke trials, despite showing efficacy in animal models of stroke. Such failed trials were probably due to the adverse effects of subtype-unselective NMDA receptor antagonists, or the limitations of targeting single injury mechanisms. SONIC was the first clinical trial of our novel multitarget neuroprotectant, nelonemdaz, administered to ischemic stroke patients who also received endovascular recanalization, which has recently become a standard of stroke care.”
Dr. Dennis W. Choi, a professor of neurology at the State University of New York, Stony Brook, a pioneer in the stroke neuroprotection field, and a scientific advisor to GNT Pharma, commented “these are very encouraging phase II results that heighten interest in seeing the results of larger phase III trials.”
In a companion phase II study with 237 acute ischemic stroke patients conducted in China, nelonemdaz was well tolerated and benefitted patients who were treated with thrombolytic drugs within 8 hours of symptom onset. A phase III study of nelonemdaz for 948 ischemic stroke patients treated with a thrombolytic drug has just begun in China.
Current observations of nelonemdaz in acute ischemic stroke patients receiving recanalization therapies promises to open up a new era of neuroprotection therapy for the treatment of stroke.
Dr. Chang Gun Kim +82-2-70-4261-0786
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Luxembourg to Start Real Life Testing of an International Standard for a Digital Circularity Fingerprint for Products27.11.2020 12:00:00 CET | Press release
The Ministry of the Economy of Luxembourg just launched phase two of the development of an international standard. It provides information on the circularity of products to all stakeholders involved along their value chains. A first viable version of the standard is being tested in real life, allowing to identify the most suitable governance model, the audit scheme and reliable IT systems for its management. Luxembourg started the Circularity Dataset Initiative in 2018 to address the difficulty for industry and consumers to access reliable data on the circular properties of a product. A lot of circularity information is missing, as its generation and handling requires too many human and financial resources. Furthermore, trade secrets are hindering transparency and reporting standards are lacking, forcing manufacturers to send out different data sets in diverse formats to customers and product platforms. To tackle these challenges, the Luxembourg government is working with multinational
Chengdu Continues to Enhance Trade Links and Cultural Exchanges to Expand Circle of Friends Around the World27.11.2020 10:24:00 CET | Press release
The Chengdu-Europe railway line spans over 10,000 kilometers across countless rivers and mountains, transporting goods to vast numbers of people across the Eurasian landmass. With increased trade, cultural links between Chengdu and Europe are also growing stronger. Against this backdrop, Chengdu-Eurasia National Pavilion Cluster (CENPC) has emerged in the Qingbaijiang District of Chengdu to further promote trade and cultural exchanges. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201127005270/en/ Head of CENPC’s pavilion for France and the Netherlands Xu Dandan at work (Photo: Business Wire) CENPC is an important platform for trade exhibition and cultural exchange between countries along the Belt and Road. With trade promotion as a foundation, the project, which is expected to feature over 40 national pavilions, aims to deepen Sichuan’s global cooperation in fields such as culture, talent, education, and science and techno
Chengdu-Europe Railway Adds Momentum to Chengdu's Rise as an International Hub, Leading to Closer Cooperation Between Chengdu and Tilburg27.11.2020 10:14:00 CET | Press release
Chengdu in China's Sichuan Province and Tilburg in The Netherlands, the two cities at the opposite ends of the Eurasian landmass, are now closely connected via an intercontinental railway that spans nearly 11,000 kilometers. In a recent interview with Xinhuanet, Roland Verbraak, general manager of GVT Group of Logistics - the Dutch partner of the Chengdu-Europe Railway, praised: "Not only are our relationships with Chinese partners getting closer, but the two cities of Chengdu and Tilburg have also become sister cities. Chengdu's international development is progressing well at a rapid pace." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201127005267/en/ Roland Verbraak, general manager of GVT Group of Logistics (Photo: Business Wire) Goods shuttling along the Chengdu-Europe Railway line have not only spurred economic growth in China and The Netherlands but also deepened links between Chengdu and places along the route, add
REPLY: Reply enters into eSports27.11.2020 09:00:00 CET | Press release
Reply, on the eve of Milan Games Week, announces its entry into eSports in collaboration with Totem eSports, a project born in 2019 that spent the year battling its way through the most competitive titles of the main ESL circuits, which for the 2021 season will be renamed Reply Totem eSports. The Reply Totem eSports team, thanks to the experience gained by its young talents at national and international level, will compete in the next season in the ESL EVC circuits on the mobile titles including Clash Royale, Brawl Stars and on a series of other titles, ranging from sports such as FIFA to FPS and strategic cards. Reply's entry into eSports is part of a wider range of initiatives aimed at supporting young technology enthusiasts. With this collaboration, Reply, which already operates in the gaming sector with Game Studio and B2B initiatives, enters a market in continuous growth, that symbolizes the impact of digitalization in all sectors. Filippo Rizzante, Reply's CTO, commented: "The eS
Vertex Announces European Commission Approval for SYMKEVI ® (tezacaftor/ivacaftor) With KALYDECO ® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years27.11.2020 09:00:00 CET | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension for SYMKEVI® (tezacaftor/ivacaftor) with KALYDECO® (ivacaftor), to include the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene that result in residual CFTR activity: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T. “With this approval, children with CF in Europe ages 6 to 11 years with the most common mutation, F508del, have a new treatment option and children with certain residual function mutations will, for the first time, have a treatment option available that addresses the underlying cause of their CF,” said Reshma Kewalramani, M.D., Chief Executive O
Thales to Deliver the World’s First Fully Integrated Unmanned Mine Countermeasures System for the Royal Navy and French “Marine Nationale”26.11.2020 20:55:00 CET | Press release
Following the first phase of the program in which two demonstrators have successfully proven their operational performances at sea, France and the United Kingdom marked the tenth anniversary of the Lancaster House treaties by signing a joint contract for Thales to start the production phase of MMCM to deliver eight unmanned mine hunting systems (four for France and four for the United Kingdom). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005783/en/ MMCM system at sea ©Thales With the threat of mines and improvised explosive devices present in all conflicts involving naval forces, countries need to strengthen the protection of their maritime domain, to ensure the protection of their assets and to safeguard the freedom of civil navigation. At the same time, it is essential to limit human exposure to mines. With 50 years of expertise serving navies around the world, Thales develops technologies that enable the transiti