Odatroltide

顺天医药今日公布其新型卒中药物LT3001（Odatroltide）两项独立的二期临床试验积极结果。LT3001是一种首创的双功能疗法，将安全再灌注与直接神经保护相结合，旨在解决当前急性缺血性卒中治疗的关键局限性。 试验数据结果 数据显示，LT3001为患有致残性急性缺血性卒中的患者带来具有临床意义的功能改善，为那些无法接受标准再灌注治疗的患者带来了新希望。该数据今日在新奥尔良举行的国际卒中会议上发布。 这一突破性结果证明了LT3001有望为治疗选择有限的卒中患者改变治疗结局。这种新型治疗药物能增强内源性纤溶并清除有害自由基，在出现致残症状的中度卒中患者中显示出尤为显著的效果。在中国进行的LT3001-202试验中，与安慰剂相比，接受LT3001治疗的伴致残症状中度卒中患者，其改良Rankin量表评分达到0-1分和0-2分的比例分别提高了8%和13%。 最值得注意的是，LT3001在大动脉粥样硬化型和影像错配阳性患者群体中均显示出功能结局的改善。在202研究中，LAA型患者（n=169）mRS评分0-2分的比例提高了11%，0-1分的比例提高了9%。205研究通过影像辅助选择验证了这些疗效信号，错配阳性患者的mRS 0-2分比例实现了10%的绝对改善。这些临床进展有望每年帮助数千名患者恢复独立生活能力。 另一项在美国、欧盟和台湾进行的补充性LT3001-205试验采用了先进的影像辅助患者选择。尽管样本量较小，该试验进一步强化了LT3001的疗效信号：与安慰剂组（17%）相比，更多伴致残症状特征的患者在LT3001治疗下达到mRS 0-1分（27%）。 "在这两项二期试验中，LT3001展示了良好的安全性，尽管连续3天多次给药，但症状性颅内出血风险并未增加，" CHI Memorial神经科学研究所所长、莫尔豪斯医学院神经病学教授、LT3001-205研究主要研究者Thomas Devlin博士表示，"LT3001在传统溶栓时间窗外显示出潜在获益，支持其用于不符合静脉溶栓或血管内治疗条件的患者，这部分患者存在高度未满足的医疗需求。两项独立试验采用不同选择策略获得的一致性结果，增强了我们对LT3001广泛适用性的信心。" 应对关键的未满足需求 "尽管经过五十多年的研究和数千个潜在药物靶点的探索，针对卒中等的神经保护药物研发尚未在美国催生出任何FDA批准的药物，" 顺天医药总经理叶嘉文博士表示，"许多药物在临床前动物研究中经常成功，但在人体试验中却未能显示出安全性或有效性。我们在不同患者群体中获得的LT3001疗效数据令人振奋，并为我们的三期项目指明了方向。" 急性缺血性卒中全球影响数百万人，许多患者出现致残症状，严重影响其生活质量和独立性。当前的再灌注疗法虽然有效，但由于时间限制、禁忌症或解剖因素，并不适用于所有患者。LT3001独特的双重机制——增强人体天然溶栓过程同时保护脑组织免受氧化损伤——为这些未得到充分治疗的患者提供了新的治疗途径。 试验评估了卒中发作24小时内的患者，重点关注定义为显著上肢或下肢运动障碍的致残症状患者。这部分患者占卒中病例的很大一部分，而当前的治疗方案仍不充足。两项二期试验均采用了严格的随机、安慰剂对照方法，其中LT3001-202研究入组了297名患者，LT3001-205研究入组了88名患者。积极信号在不同地理区域和患者选择标准中的一致性，凸显了这些研究结果的稳健性。 关于LT3001 LT3001代表了一种治疗急性卒中的创新方法，同时针对卒中病理生理中的血栓形成和氧化应激成分。与仅关注清除血栓的传统方法不同，LT3001的双重机制针对卒中损伤的多个方面，有望延长治疗时间窗并扩大患者适用人群。 公司正在通过全面的临床开发推进LT3001，计划开展三期试验，以在更大的患者群体中进一步验证这些前景广阔的结果。 下一步及全球开发计划 这些综合的二期结果为支持LT3001继续开发用于急性缺血性卒中提供了关键的临床证据。值得注意的是，顺天医药近期已收到美国食品药品监督管理局关于其LT3001三期开发计划的反馈。 基于此反馈，顺天医药旨在加速LT3001的全球三期开发，为全球卒中患者提供创新有效的治疗选择。 关于急性缺血性卒中 根据世界卫生组织数据，卒中是60岁以上人群第二大死亡原因，全球每年约有600万人死亡。卒中可分为出血性（出血）或缺血性（脑部关键区域血流中断）。研究表明缺血性卒中最为常见，约占所有卒中病例的85%。卒中是一种全球医疗需求远未得到满足的重大疾病。全球每年有1500万人罹患卒中。由于目前仅有手术和有限的治疗方案可用，80%的卒中患者没有其他治疗选择或未能获得理想疗效。 参考来源： https://www.prnewswire.com/ 免责声明：本公众号内容仅作交流参考，不作为诊断及医疗参考，专业医学问题请咨询专业人士或专业医疗机构。

Breakthrough Phase 2 Trial Results Show Promise for Patients Ineligible for Standard Reperfusion Therapies Data Presented at International Stroke Conference Data Show That LT3001 Delivers Meaningful Functional Improvements in Patients Suffering from Disabling Acute Ischemic Stroke (AIS) TAIPEI, Feb. 6, 2026 /PRNewswire/ -- Lumosa Therapeutics (Lumosa; 6535.TWO) today announced positive results from two independent Phase 2 clinical trials with its novel stroke drug LT3001 (Odatroltide). LT3001 is a first-in-class dual-functional therapy that combines safe reperfusion with direct neuroprotection, addressing key limitations of current acute ischemic stroke treatments. These data revealed that LT3001 delivers meaningful functional improvements in patients suffering from disabling acute ischemic stroke (AIS), offering new hope for those who cannot receive standard reperfusion treatments. These data were reported here today at the International Stroke Conference in New Orleans. The groundbreaking results demonstrate LT3001's potential to transform outcomes for stroke patients facing limited therapeutic options. The novel therapeutic agent, which enhances endogenous fibrinolysis and scavenges harmful free radicals, showed particularly impressive results in moderate stroke patients with disabling symptoms. In the LT3001-202 trial conducted in China, moderate stroke patients with disabling symptoms treated with LT3001 achieved 8% and 13% improvements in modified Rankin Scale (mRS) scores of 0-1 and 0-2 respectively, compared to placebo. Most remarkably, LT3001 showed improvement in functional outcomes in LAA and mismatch-positive populations. In Study 202, LAA patients (n=169) showed an 11% improvement in mRS 0–2 and a 9% gain in mRS 0–1. Study 205 validated these signals via imaging assisted selection, with mismatch-positive patients achieving a 10% absolute improvement in mRS 0–2. These clinical advances could restore independence to thousands of patients annually. The complementary LT3001-205 trial, spanning the US, EU, and Taiwan, utilized advanced imaging-assisted patient selection. Despite smaller sample sizes, the trial reinforced LT3001's efficacy signals, with patients showing disabling features achieving mRS 0-1 outcomes more often with LT3001 (27%) compared to placebo (17%). "Across the two Phase 2 trials, LT3001 demonstrated a favorable safety profile, with no increase in symptomatic intracranial hemorrhage (sICH) despite multi-dose administration over 3 days," said Thomas Devlin, MD, PhD, FSVIN, Director of the CHI Memorial Neuroscience Institute, Professor of Neurology Morehouse School of Medicine and principal investigator of the LT3001-205 study. "LT3001 showed potential benefit beyond the conventional thrombolytic time window, supporting its use in patients ineligible for IV thrombolysis or EVT, a population with high unmet need. The consistency of results across two independent trials, using different selection strategies, strengthens our confidence in LT3001's broad applicability." Addressing a Critical Unmet Need "Despite over five decades of research and thousands of potential drug targets, the development of neuroprotective drugs for conditions like stroke has not resulted in any FDA-approved drugs in the U.S.," said Sheng-Wen Yeh (Mimi) Ph.D., general manager, Lumosa. "While many drugs frequently succeed in preclinical, animal-based studies, they fail to show safety or efficacy in human trials. Our efficacy data with LT3001, spanning diverse patient populations, is exciting and provides direction for our Phase 3 programs." Acute ischemic stroke affects millions globally, with many patients experiencing disabling symptoms that severely impact their quality of life and independence. Current reperfusion therapies, while effective, are not suitable for all patients due to timing constraints, contraindications, or anatomical factors. LT3001's unique dual mechanism - enhancing the body's natural clot-dissolving processes while protecting brain tissue from oxidative damage - offers a new therapeutic pathway for these underserved patients. The trials evaluated patients within 24 hours of stroke onset, focusing on those with disabling symptoms defined as significant arm or leg motor impairment. This patient population represents a substantial portion of stroke cases where current treatment options remain inadequate. Both Phase 2 trials employed rigorous randomized, placebo-controlled methodologies, with LT3001-202 enrolling 297 patients and LT3001-205 including 88 patients. The consistency of positive signals across different geographic regions and patient selection criteria underscores the robustness of these findings. About LT3001 LT3001 (Odatroltide) represents an innovative approach to acute stroke treatment, targeting both the thrombotic and oxidative components of stroke pathophysiology. Unlike traditional approaches that focus solely on clot removal, LT3001's dual mechanism addresses multiple aspects of stroke injury, potentially extending the therapeutic window and broadening patient eligibility. The Company is advancing LT3001 through comprehensive clinical development, with plans for Phase 3 trials to further validate these promising results in larger patient populations. Next Steps and Global Development Plans These combined Phase 2 results provide critical clinical evidence supporting the continued development of LT3001 for acute ischemic stroke. Of note, Lumosa recently received feedback from the U.S. Food and Drug Administration regarding its Phase 3 development plans for LT3001. Based on this feedback, Lumosa aims to accelerate global Phase 3 development of LT3001 and deliver innovative and effective treatment options for stroke patients worldwide. About Acute Ischemic Stroke According to the World Health Organization (WHO), stroke is the second leading cause of death for people over the age of 60 with approximately 6 million deaths in the world per year. Stroke can be categorized as hemorrhagic (bleeding) or ischemic (lack of blood flow to critical areas of the brain). Studies show ischemic stroke is most common, occurring in about 85% of all stroke cases. Stroke is notably a disease with significant global unmet medical need. There are 15 million people worldwide who suffer a stroke each year. Because only surgery and limited therapeutic options are currently available, 80% of stroke patients are left with no other treatment options or without desired outcomes. About Lumosa Lumosa Therapeutics, Inc. () is a clinical-stage pharmaceutical company dedicated to the development of novel therapies and solutions for neurologic diseases with urgent unmet medical need. In addition to utilizing its own technology platform, the Company is also actively engaged in scientific licensing and co-development collaboration -- building a pipeline from early to late-stage assets consisting of first-in-class and best-in-class drugs. Lumosa's mission is to enrich patients' quality of life through pioneering medical science, diverse collaborations, and a commitment to remain genuine and ever-evolving. Central to this mission is the Company's objective to develop its novel small molecule, LT3001, for the treatment of acute ischemic stroke, a medical disease for which more effective therapies are greatly needed. SOURCE Lumosa Therapeutics Co., Ltd. 21% more press release views with Request a Demo