GNT Pharma Co., Ltd.

▲3月7-8日 成都生物医药创新者峰会 · 点击立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融云数据www.pharnexcloud.com监测显示：普洛药业股份有限公司发布 关于全资子公司终止注射用索法地尔 III 期临床试验的公告  。本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗漏。   普洛药业股份有限公司（以下简称“公司”）全资子公司浙江普洛家园药业有限公司（以下简称“家园药业”）研发的注射用索法地尔治疗急性缺血性脑卒中的临床研究处于 III 期临床试验阶段。近日，基于该药物目前临床研究进展及后续研发投入等因素的综合评估，公司决定终止注射用索法地尔治疗急性缺血性脑卒中的 III 期临床试验。现将有关情况公告如下：   一、终止临床的药物基本信息    1、药品名称：注射用索法地尔    2、剂型：注射剂    3、注册分类：化学药品Ⅰ类    4、适应症：急性缺血性脑卒中    5、批件号：2016L08185    二、药物研发相关情况及终止原因    注射用索法地尔是公司全资子公司家园药业开发的一种创新药物，临床试验的适应症为：急性缺血性脑卒中。家园药业于 2009 年从韩国 Neurotech 公司（现名：GNT Pharma）引进注射用索法地尔项目，具有大中华地区的自主知识产权。   公司全资子公司家园药业于 2014 年 06 月 21 日收到原国家食品药品监督管 理局签发的《药物临床试验批件》，批件号为 2014L01020，同意本品进行 I 期临 床试验。2015 年 11 月完成 I 期临床试验。2016 年 09 月收到原国家食品药品监 督管理局签发的《药物临床试验批件》，批件号为 2016L08185，同意本品继续进 行临床试验 I/II/III 期。2019 年 7 月完成 II 期临床试验，并于 2020 年 12 月启动 III 期临床试验。   经公司评估，结合 III 期临床试验运行期间全国大范围封控影响，可能导致 临床研究数据的完整性和准确性风险以及方案偏离可能引起的数据质量风险，公司决定终止该 III 期临床试验。该项临床试验的终止不影响注射用索法地尔在 GNT Pharma 的临床研究以及公司未来该项目的其他相关临床研究。 临床试验终止后，该临床试验将停止入组，已经入组的受试者将继续按照临床试验方案进行随访，已入组受试者的权益将得到充分保障。三、对公司的影响及风险提示  截至本公告日，注射用索法地尔研发投入共计 12,227.74 万元（未经审计）。按照相关会计准则和公司会计政策，注射用索法地尔的研发投入已全部费用化并计入相应会计期间损益，不会对公司本年度业绩产生重大影响。  公司一直高度重视研发创新，持续加大研发投入，严格控制研发成本，不断提高研发效率；但新药研发风险高、周期长，存在诸多不确定性。敬请广大投资者谨慎决策，注意投资风险。 特此公告。                                        普洛药业股份有限公司董事会                                               2024 年 1 月 26 日版权声明：本文转自药融投资，如不希望被转载的媒体或个人可与我们联系，我们将立即删除 活动推荐  3月 • NDC x 2024新药创新者峰会  关键词：  ADC，改良型新药，小分子新药，GLP-1药物（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

1月26日，普洛药业发布公告，称基于注射用索法地尔目前临床研究进展及后续研发投入等因素的综合评估，决定终止该产品治疗急性缺血性脑卒中的III期临床试验。索法地尔是普洛药业全资子公司家园药业开发的一种创新药物，临床试验的适应症为：急性缺血性脑卒中。家园药业于2009年从韩国Neurotech（现名：GNT Pharma）引进索法地尔项目，具有大中华地区的自主知识产权。索法地尔在2020年12月启动III期临床试验。结合III期临床试验运行期间全国大范围封控影响，可能导致临床研究数据的完整性和准确性风险以及方案偏离可能引起的数据质量风险，公司决定终止该III期临床试验。该项临床试验的终止不影响索法地尔在GNT Pharma的临床研究以及公司未来该项目的其他相关临床研究。 临床试验终止后，该临床试验将停止入组，已经入组的受试者将继续按照临床试验方案进行随访，已入组受试者的权益将得到充分保障。截至目前，索法地尔研发投入共计1.22亿元（未经审计）。Copyright © 2023 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

Promising efficacy and safety profiles were observed in prior Phase II studies in acute ischemic stroke patients treated with recanalization therapies. The ENIS-3 trial has achieved >33% of target enrollment (948 patients). The independent data monitoring committee (IDMC) has completed interim analysis and indicated that the trial should continue. The RODIN trial has achieved >45% of target enrollment (496 patients) in 7 months. YONGIN, South Korea, Sept. 19, 2022 (GLOBE NEWSWIRE) -- GNT Pharma Inc. announces that the independent data monitoring committee (IDMC) for ENIS-3 (Efficacy and safety of Nelonemdaz for Ischemic Stroke) has completed a pre-specified interim analysis encompassing 227 acute ischemic stroke patients treated with placebo or nelonemdaz within 8 hours of onset in China. The IDMC concluded that the ENIS-3 trial should continue as planned without modification. In the prior phase II trial in China (ENIS, 237 patients), administration of nelonemdaz reduced disability primarily in moderate to severe ischemic stroke patients treated with a thrombolytic drug. The ENIS-3 trial was then designed to examine the efficacy and safety of nelonemdaz in 946 patients with moderate to severe acute ischemic stroke treated with tPA within 8 hours of stroke onset. In South Korea, another multicenter, double-blinded phase III trial (RODIN: Rescue on Reperfusion Damage in Cerebral Infarction by Nelonemdaz) has been initiated to further explore the functional and neuroprotection efficacy of nelonemdaz in acute cerebral ischemia and reperfusion, aiming to enroll a total of 496 patients with moderate to severe ischemic stroke who receive endovascular thrombectomy within 12 hours of stroke onset. The RODIN trial has now enrolled more than 224 patients over the last 7 months and is expected to complete enrollment in the middle of 2023. In the prior phase II study published online in the peer-reviewed journal Stroke in September, nelonemdaz treatment was associated with better functional outcomes than placebo in moderate to severe ischemic stroke patients who received endovascular thrombectomy within 8 hours of stroke onset. Good functional outcomes were analyzed by a fraction of 0 (no disability symptoms) – 2 (slight disability, able to look after own affairs without assistance) on the modified Rankin Scale (mRS) and a Barthel index of >90 (functional independence in activities of daily living) at 12 weeks. An mRS score of 0–2 was achieved in 54.1% (33/66) and 63.2% (36/57) patients in the placebo and high-dose groups treated with 5,250 mg nelonemdaz, respectively. The common odds ratio (90% confidence interval) indicating a favorable shift in mRS scores was 1.61 (0.94–2.76) between the placebo and high-dose groups. A Barthel index of >90 was observed in 24 (43.6%) and 34 (63.0%) patients in the placebo and high-dose groups, respectively. An overall trend towards excellent outcome (mRS score of 0 and BI of >90) and reduced mortality at 12 weeks, was observed in the nelonemdaz treatment groups compared to placebo. Dr. Dennis W. Choi, Professor of Neurology, Stony Brook Medicine, and a pioneer in identifying pathological mechanisms of ischemic brain injury said, “Phase III studies of nelonemdaz appear to be progressing well. These trials represent a key shot on the worldwide goal of developing an effective neuroprotective treatment for ischemic stroke.” Nelonemdaz is a multi-target neuroprotectant acting as both a moderate NR2B-selective N-methyl d-aspartate (NMDA) receptor antagonist and a potent spin trapper that ameliorates both fast NMDA receptor-mediated neuronal death and the delayed free-radical mediated brain cell degeneration occurring hours-to-days after ischemic stroke. In animal models of stroke, superior safety and efficacy was observed for nelonemdaz treatment compared with NMDA antagonists or antioxidants alone. In prior phase I and phase II studies, administration of nelonemdaz was well-tolerated, with no appearance of the psychotic symptoms seen in humans exposed to previous NMDA receptor antagonist drugs. “Recent advances in recanalization therapy remarkably improve functional outcomes after acute ischemic stroke and open up new opportunities for neuroprotection therapy based on early delivery and reperfusion,” said Dr. Byoung Joo Gwag, founder and CEO of GNT Pharma. “Nelonemdaz is safe and shows promising efficacy profiles in patients receiving thrombolytic or endovascular therapy. When combined with recanalization therapies, nelonemdaz will hopefully break new ground in treating ischemic brain injury, reducing consequent disability and mortality.” About nelonemdaz Nelonemdaz is a breakthrough multi-target neuroprotectant drug candidate, acting both as a moderately powerful, NR2B subtype-selective NMDA receptor antagonist, and a powerful antioxidant. It is designed to safely ameliorate NMDA receptor-mediated excitotoxicity while also reducing free radical toxicity, two major routes of brain cell death after stroke. About the phase II ENIS Results In China, a phase II study of nelonemdaz (ENIS trial) has been completed in acute ischemic stroke patients receiving a thrombolytic drug within 8 hours of stroke onset (n=237). Administration of nelonemdaz for 5 days was well-tolerated and showed promising efficacy in moderate to severe stroke patients with initial National Institutes of Health Stroke Scale (NIHSS) scores of ≥6 on admission. The fraction of recovery to normal in placebo-treated group was 13%, 16%, and 26% at 14 days, 30 days, and 90 days, respectively, which improved to 25%, 34% and 44% in the group treated with high dose nelonemdaz. About the phase II SONIC Results In South Korea, a phase II, double-blind, randomized, placebo-controlled, multi-center study (SONIC trial) has been conducted to assess the safety and efficacy of nelonemdaz in acute ischemic stroke patients treated with endovascular recanalization within 8 hours of stroke onset. SONIC enrolled 208 acute ischemic stroke patients with NIHSS score of ≥8. Patients randomly received infusions of placebo, 500 mg nelonemdaz (low-dose group), or 750 mg nelonemdaz (high-dose group) prior to thrombectomy. Low-dose and high-dose nelonemdaz groups then received 9 consecutive infusions of 250 mg and 500 mg every 12 hours, respectively. The primary outcome was the percentage of patients achieving at least a good functional outcome 12 weeks later. Good functional outcome was defined as 0 (no disability symptoms) – 2 (slight disability, able to look after own affairs without assistance) on the modified Rankin Scale (mRS), the most widely used outcome measure in stroke research. In the full analysis set encompassing 183 patients, an mRS score of 0–2 at 12 weeks was achieved in 54.1% (33/66), 61.5% (40/65), and 63.2% (36/57) patients in the placebo, low-dose, and high-dose groups, respectively. In secondary outcomes, the common odds ratio (90% confidence interval) indicating a favorable shift in mRS scores at 12 weeks was 1.55 (0.92–2.60) between the placebo and low-dose groups and 1.61 (0.94–2.76) between the placebo and high-dose groups. A Barthel index of >90 (functional independence in activities of daily living) at 12 weeks was observed in 24 (43.6%), 34 (54.8%), and 34 (63.0%) patients in the placebo, low-dose, and high-dose groups, respectively. An overall trend towards excellent outcome (mRS score of 0 and BI of >90) and reduced mortality at 12 weeks, was observed in the nelonemdaz treatment groups compared to placebo. No serious adverse events were observed in nelonemdaz treatment groups. The SONIC trial results have been published in the journal Stroke in September. About the phase III ENIS-3 Trial Based upon the encouraging results observed in the ENIS trial, Apeloa Pharmaceutical of Hengdian Group, GNTP’s Chinese partner, initiated in December 2020 an ongoing phase III study of nelonemdaz in 948 patients with moderate to severe (9≤NIHSS≤22) acute ischemic stroke (ENIS III), engaging 40 Chinese university stroke centers. All patients receive a thrombolytic drug tPA prior to administration of placebo or nelonemdaz within 8 hours of stroke onset. About the phase III RODIN Trial In September 2021, the Korea Ministry of Food and Drug Safety (MFDS) approved an Investigational New Drug Application (IND) for a phase III study of nelonemdaz in acute ischemic stroke patients (RODIN trial). RODIN is designed to investigate the safety and efficacy of 5,250 mg nelonemdaz in 496 patients with severe ischemic stroke receiving endovascular thrombectomy within 12 hours of stroke onset. Patients will be enrolled at 23 university stroke centers and evaluated by mRS, NIHSS, BI, and MRI over 90 days following stroke. At present, RODIN has enrolled 224 patients at 21 university stroke centers including Seoul Asan Medical Center. About GNT Pharma: GNT Pharma was founded in April 1998 by eight professors in the fields of neuroscience, pharmacology, medicinal chemistry, psychology, ophthalmology, and cell biology who had all been investigating mechanisms of neuronal cell death. Since then, GNTP has discovered and developed several innovative drug candidates for the treatment of nervous system disorders such as stroke and Alzheimer’s disease. Disclosure Notice This press release includes forward-looking statements about GNT Pharma’s efforts to treat acute ischemic stroke and the investigational anti-stroke drug nelonemdaz that are based on management’s beliefs and assumptions, expectations, estimates, and projections as well as facts and factors currently known by GNT Pharma. Statements included in this release that are not historical data and facts, including the words “plans”, “expects”, or similar expressions and statements constitute forward-looking statements. Such statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed in these forward-looking statements. Risks and uncertainties include those associated with the impact COVID-19 could have on our business, and including but not limited to, those inherent in research and development, including completion dates of clinical trials, final data from clinical trials, and the regulatory process. You are cautioned not to rely on these forward-looking statements as there are important factors that could cause actual results to differ materially from forward-looking statements. GNT Pharma undertakes no obligation to update forward-looking statements. Contacts 1. Eun Chan Park, PhD (US Office): ecpark@gntpharma.com (1-848-228-6841) 2. Chang Geun Kim, PhD: cgkim@gntpharma.com (+82-70-4261-0786) 3. Byung Chul Kim, Public Relations Director: bckim@gntpharma.com (+82-70-4262-4755)