This is a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease (AD) dementia.

开始日期2019-03-28

申办/合作机构

Quince Therapeutics, Inc.

NCT03418688 / Completed临床1期

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease

The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects.

开始日期2018-03-06

申办/合作机构

Quince Therapeutics, Inc.

NCT03331900 / Completed临床1期

A Phase 1 Single Ascending Dose Study of COR388 HCl

The study is a randomized, double-blind, placebo-controlled, dose escalation, first-in-human trial of the safety and tolerability of COR388 HCl in healthy male and female subjects.

开始日期2017-12-11

申办/合作机构

Quince Therapeutics, Inc.

100 项与 Atuzaginstat 相关的临床结果

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100 项与 Atuzaginstat 相关的转化医学

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100 项与 Atuzaginstat 相关的专利（医药）

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项与 Atuzaginstat 相关的文献（医药）

2021-01-01·Neural regeneration research2区 · 医学

Oral frailty and neurodegeneration in Alzheimer’s disease

2区 · 医学

ReviewOA

作者: Dibello, Vittorio ; Panza, Francesco ; Sardone, Rodolfo ; Manfredini, Daniele ; Lobbezoo, Frank ; Zupo, Roberta ; Lozupone, Madia ; Dibello, Antonio ; Daniele, Antonio

Frailty is a critical intermediate status of the aging process with a multidimensional and multisystem nature and at higher risk for adverse health-related outcomes, including falls, disability, hospitalizations, institutionalization, mortality, dementia, and Alzheimer's disease. Among different frailty phenotypes, oral frailty has been recently suggested as a novel construct defined as a decrease in oral function with a coexisting decline in cognitive and physical functions. We briefly reviewed existing evidence on operational definitions of oral frailty, assessment and screening tools, and possible relationships among oral frailty, oral microbiota, and Alzheimer's disease neurodegeneration. Several underlying mechanism may explain the oral health-frailty links including undernutrition, sarcopenia linked to both poor nutrition and frailty, psychosocial factors, and the chronic inflammation typical of oral disease. Oral microbiota may influence Alzheimer's disease risk through circulatory or neural access to the brain and the interplay with periodontal disease, often causing tooth loss also linked to an increased Alzheimer's disease risk. On this bases, COR388, a bacterial protease inhibitor targeting Porphyromonas gingivalis implicated in periodontal disease, is now being tested in a double-blind, placebo-controlled Phase II/III study in mild-to-moderate Alzheimer's disease. Therefore, oral status may be an important contributor to general health, including Alzheimer's disease and late-life cognitive disorders, suggesting the central role of preventive strategies targeting the novel oral frailty phenotype and including maintenance and improvement of oral function and nutritional status to reduce the burden of both oral dysfunction and frailty.

2020-02-01·Pharmacology research & perspectives4区 · 医学

Treatment of Porphyromonas gulae infection and downstream pathology in the aged dog by lysine‐gingipain inhibitor COR388

4区 · 医学

ArticleOA

作者: Haditsch, Ursula ; Araujo, Joseph ; Ryder, Mark I. ; Raha, Debasish ; Holsinger, Leslie J. ; Lynch, Casey ; Ermini, Florian ; Nguyen, Mai ; De Lannoy, Ines A. M. ; Arastu‐Kapur, Shirin ; Dominy, Stephen S.

Abstract:

COR388, a small‐molecule lysine‐gingipain inhibitor, is currently being investigated in a Phase 2/3 clinical trial for Alzheimer's disease (AD) with exploratory endpoints in periodontal disease. Gingipains are produced by two species of bacteria, Porphyromonas gingivalis and Porphyromonas gulae, typically associated with periodontal disease and systemic infections in humans and dogs, respectively. P. gulae infection in dogs is associated with periodontal disease, which provides a physiologically relevant model to investigate the pharmacology of COR388. In the current study, aged dogs with a natural oral infection of P. gulae and periodontal disease were treated with COR388 by oral administration for up to 90 days to assess lysine‐gingipain target engagement and reduction of bacterial load and downstream pathology. In a 28‐day dose‐response study, COR388 inhibited the lysine‐gingipain target and reduced P. gulae load in saliva, buccal cells, and gingival crevicular fluid. The lowest effective dose was continued for 90 days and was efficacious in continuous reduction of bacterial load and downstream periodontal disease pathology. In a separate histology study, dog brain tissue showed evidence of P. gulae DNA and neuronal lysine‐gingipain, demonstrating that P. gulae infection is systemic and spreads beyond its oral reservoir, similar to recent observations of P. gingivalis in humans. Together, the pharmacokinetics and pharmacodynamics of COR388 lysine‐gingipain inhibition, along with reduction of bacterial load and periodontal disease in naturally occurring P. gulae infection in the dog, support the use of COR388 in targeting lysine‐gingipain and eliminating P. gingivalis infection in humans.

Nigerian journal of physiological sciences : official publication of the Physiological Society of Nigeria

Porphyromonas gingivalis, neuroinflammation and Alzheimer’s disease

Review

作者: Malekzadeh, Samira ; Owoyele, Prof Victor

The oral microbiota dysbiosis, as well as lifestyle, geographical location, drug consumption, and dietary habits, are involved in the incidence and progression of dementia, Mild Cognitive Impairment (MCI), and some diseases such as obesity, diabetes, cardiovascular disease, preterm birth, rheumatoid arthritis, cancer, inﬂammatory bowel disease, and neurodegenerative disease e.g., Parkinson’s Disease (PD) and Alzheimer’s Disease (AD). AD is the most common cause of neurodegenerative disorder in the elderly. Also, neuroinﬂammation is the most common cause of AD pathogenesis. This study investigated the possible relationship between Porphyromonas gingivalis (P. gingivalis) and Alzheimer’s Disease. This review is based on research studies indexed in Scopus, Science Direct, PubMed, and Google Scholar databases. The oral microbiota comprised various microorganisms, such as fungi, archaea, and bacteria. Porphyromonas gingivalis (P. gingivalis) is one of the microorganisms, it stimulates host immune cells and releases cytokines, lysosomal enzymes, nitric oxide, and reactive oxygen species that lead to cell damage, apoptosis, and inflammation. Therefore, periodontal disease (PerioD) through systemic inflammation leads to some problems like the progression of MCI, production and aggregation of beta-amyloid (Aβ) and tau protein in the brain of the elderly population. In addition, some treatment methods could modulate the adverse effects of P. gingivalis like probiotic dietary supplements, maintaining personal hygiene, as well as gingipain inhibitors which modulate cytokines through blocked Aβ production, ApoE proteolysis, and reduced neuroinflammation. In addition, therapeutic compounds like COR388 and COR286, as gingipain inhibitors, prevent P. gingivalis colonization in the brain and have a beneficial action in some conditions like aspiration pneumonia, low birth rate, rheumatoid arthritis, PerioD and AD.

项与 Atuzaginstat 相关的新闻（医药）

2024-06-04

·Pharmaceutical Technology

FDA fast tracks Quince Therapeutics’ rare ataxia drug EryDex

The FDA has granted fast track designation to Quince Therapeutics’ Phase III drug candidate EryDex to treat rare disease ataxia-telangiectasia. Credit: grandbrothers via Shutterstock. California-based biotech Quince Therapeutics has won fast track designation from the US Food and Drug Administration (FDA) for its ataxia-telangiectasia (A-T) drug EryDex. Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Leading Guide to Clinical Packaging Companies in contract Manufacturing for the Pharmaceutical Industry According to the 3 June announcement, fast track designation was awarded to address a high unmet medical need for patients with A-T. The status allows for earlier interactions with the FDA as Quince seeks accelerated approval, and also the possibility to undergo rolling reviews. A-T is a rare disease of the nervous and immune systems, affecting motor movement and speech. EryDex utilises autologous intracellular drug encapsulation (AIDE) technology to administer dexamethasone sodium phosphate (DSP) into a patient’s red blood cells. Red blood cells filled with DSP are then reinfused into the patient, allowing for the slow release of steroids over several weeks, without the long-term toxicity commonly associated with chronic administration. The FDA lifted a partial clinical hold that was on the drug in October 2023, advancing it into the Phase III NEAT study (NCT06193200). The FDA removed the partial clinical hold after requesting additional information on plastics used in the single-use EryKit, which is part of EryDex. Changes were made to comply with recent European regulations. The NEAT study will enrol approximately 86 six- to nine-year-old patients with A-T as the primary analysis population, as well as 20 patients over the age of ten years. Participants will be randomised between EryDex or placebo and treatment will involve six infusions once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last visit completion in the rescored modified International Cooperative Ataxia Rating Scale (RmICARS). See Also: FDA hearing set to discuss advisory committee members’ conflicts and more Be Bio’s haemophilia B treatment gains FDA orphan drug status Quince shared in an April 2024 business update that it anticipates topline results in H2 2025 with a potential NDA submission in 2026. Quince inherited EryDex in July 2023 when it acquired biotech EryDel in a $485m deal in October 2023. Formerly known as Cortexyme, Quince changed its name in 2022 and focused on rare diseases following several setbacks, including a clinical hold on its Alzheimer’s disease drug atuzaginstat. In the announcement accompanying the fast track, Quince CEO Dirk Thye said: “The granting of fast track status for EryDex System marks another important milestone in our endeavour to identify a beneficial therapeutic solution for patients with A-T. “We have initiated our pivotal Phase III NEAT clinical trial, which is being conducted in the US, UK, and the European Union.”

快速通道临床3期并购孤儿药

2024-01-16

·药渡Daily

展望2024 | 阿尔兹海默症治疗将全面迈进新时代

阿尔茨海默症患者的脑海中，仿佛有一块橡皮擦，擦去了记忆和时光。这是一件多么可怕的事情，意味着你的成就、你的经历、你的所爱，全部都离你而去，那么活着，也仅仅只是活着而已。多年来，全球药企投入了巨大的经费进行阿尔茨海默症药物的研发，但大部分以失败告终，前路茫茫似乎看不到希望。所幸，我们生活在一个不断进取的时代，随着近期阿尔茨海默症新药在中国的获批，这一长久未曾进展的领域正在不断透进光来。重磅新药仑卡奈单抗（Lecanemab）的获批，似乎正在成为治疗阿尔兹海默症的一个里程碑。作为2003年来首获美国FDA完全批准的治疗阿尔兹海默症新药，仑卡奈单抗确实十分优秀。2022年11月，仑卡奈单抗针对早期阿尔兹海默症的III期试验结果发表在国际权威医学期刊《新英格兰医学杂志》上。这项被称为Clarity AD研究的试验共在北美、欧洲、亚洲的235个研究点入组1795名患者，主要终点为治疗18个月后临床痴呆评分总和（CDR-SB）相较于基线的变化，该评分越高意味着患者临床功能越低。来源：卫材官微试验结果显示，接受治疗18个月后，仑卡奈单抗组和安慰剂组的CDR-SB评分分别为1.21和1.66。相较安慰剂组，仑卡奈单抗组CDR-SB评分低0.45，评分增速降低了27%。此外，接受治疗6个月后，仑卡奈单抗组CDR-SB评分就开始出现显著性差异，且两组评分的绝对差异随着时间的推移而扩大。基于观察到的数据和外推至30个月的CDR-SB进行的斜率分析，接受仑卡奈单抗治疗25.5个月相当于安慰剂治疗18个月时的水平，这表明仑卡奈单抗可以延缓疾病进展达7.5个月。仑卡奈单抗使患者CDR-SB的临床下降减少了27%来源：华福证券研报这项临床试验也成为仑卡奈单抗在此次中国获批的依据。仑卡奈单抗成功上市，也为后来者在阿尔茨海默症治疗药物的研发注入了一剂强心剂。不过，也不能过于乐观，因为到目前为止，阿尔茨海默症的发病机制对人类来说，还是个迷。未解之谜1907年，德国医生Alois Alzheimer发表了一个病例，他持续跟踪一名女性患者的病程进展直至她在发病后四年半死亡，并在患者脑组织中发现大量神经炎性斑和神经原纤维缠结。1910年，德国著名精神病学家Emil Kraepelin首次将由此种病理改变引起的临床症状与体征命名为“阿尔茨海默症”。在中国，该疾病也被称为“老年痴呆”。对于阿尔茨海默症的研究迄今已过百年，但依然未取得突破性进展。阿尔茨海默症的发病机制复杂，至今仍未完全破译具体机制，通常认为是老化、遗传和环境多种因素的共同结果。患者中普遍存在神经元丢失、突触障碍、胞外淀粉样蛋白β（Aβ）沉积形成淀粉样斑块、异常磷酸化Tau蛋白形成胞内神经元纤维缠结。目前致病机制主要存在三大主流假说：Aβ类淀粉样蛋白级联假说Aβ沉积形成淀粉样斑块是阿尔茨海默症的主要病理特征之一。Aβ由淀粉样前体蛋白（APP）经分泌酶降解生成，在淀粉样途径中，APP被BACE剪切产生sAPPβ蛋白，sAPPβ蛋白被γ-secretase继续剪切，生成包括Aβ1-42、Aβ1-40等Aβ多肽并释放到胞外，最终聚集形成淀粉样蛋白斑，导致阿尔茨海默症发生。渤健的Aducanumab、Lecanemab和礼来的Donanemab都是靶向Aβ淀粉样蛋白的阿尔茨海默症药物，为Aβ假说提供坚定支撑。β类淀粉样蛋白的级联反应和主要治疗方法来源：西南证券研报Tau蛋白异常磷酸化假说病理状态下，胞内Tau蛋白过度或异常磷酸化使其丧失促微管组装的生物学活性，微管解聚、轴突运转出现障碍，进而引起神经细胞的凋亡，导致阿尔茨海默症发生。Tau蛋白的磷酸化与阿尔茨海默症患者病程中认知功能缺失密切相关。以Tau蛋白为靶点的阿尔茨海默症药物正在研发中，根据药渡数据，进入临床试验的有Tideglusib、Saracatinib、Nilotinib等小分子抑制剂。Tau蛋白异常磷酸化路线和主要治疗方法来源：西南证券研报胆碱能假说该假说认为阿尔茨海默症产生是由于患者脑内的神经递质存在缺陷，导致胆碱能神经元受到损伤。乙酰胆碱酯酶（AChE）和乙酰胆碱转移酶（ChAT）的活性下降是乙酰胆碱（Ach）浓度下降、胆碱能活性下降的主要原因。根据药渡数据，截至目前全球共有141种阿尔茨海默症治疗方法或药物研发管线，其中与神经递质调节以及突触功能改善上相关的药物管线有15个。阿尔茨海默症胆碱能神经元的化学变化来源：西南证券研报根据世界卫生组织《2023年世界社会报告》数据显示，2021年全球65岁以上老年人口数约为7.6亿，预计2050年全球老年人口数将增至16亿以上，人口老龄化背景下痴呆及轻度认知损害患者数将持续增加。截至2018年全球约3310万人患有阿尔茨海默症，2050年这一数字将增至2.42亿。而在中国，据Frost&Sullivan数据，2020年中国阿尔茨海默症患者数为1250万人，预计将在2030年增至1950万人；1990年阿尔茨海默症的死亡顺位处于第10位，20年后已跃升至第5位。不论是年龄标化患病率，还是年龄标化死亡率均高于全球平均水平。根据《中国阿尔茨海默症诊治指南》，胆碱酯酶抑制剂中的多奈哌齐、卡巴拉汀、加兰他敏是目前治疗轻中度阿尔茨海默症推荐用药，中重度患者则推荐使用谷氨酸受体拮抗剂中的美金刚。但这些推荐用药疗效普遍不足，只能短期控制症状，难以针对明确病因机制入手延缓疾病进程。根据《阿尔茨海默病患者需求洞察报告》，在接受调查的1000名受访患者中（75.7%接受了药物治疗），其中有近半数接受药物治疗患者反馈了对现有药物治疗效果的不满意。因此，市场急需治疗阿尔茨海默症新药。但由于发病机制不明确，关于阿尔茨海默症的新药研发可谓屡战屡败。根据美国药物生产与研发协会数据显示，全球累计在阿尔兹海默病上的研发投入超过6000亿美元，失败的临床药物超过300种，失败率超过99%。2012年，强生/辉瑞的单抗药物Bapineuzumab在III期临床惨遭失败；2014年，罗氏的Gantenerumab的III期临床宣告失败；2016年，新加坡生物技术公司TauRx的LMTX宣布III期临床试验未能改善患者的认知功能宣告失败；2017年，默沙东宣布停止开发BACE抑制剂药物Verubecestat；2018年，强生宣布其终止了BACE抑制剂Atabecestat II/III期临床试验等。直到2021年6月，美国FDA批准了Aducanumab的上市，才终结了2003年之后未有阿尔茨海默症治疗药物获批的尴尬处境。但是，这款药物的上市却引起了很大的争议。艰难前行Aducanumab由渤健和卫材合作开发，是一种高亲和力、靶向-Aβ构象表位的全人IgG1单克隆抗体，可选择性与AD患者大脑中的淀粉样蛋白沉积结合，通过激活免疫系统清除大脑中沉积Aβ蛋白，进而延缓AD进程，有效支持了淀粉样蛋白假说。然而，在2019年3月，两项临床试验ENGAGE和EMERGE在III期临床中展现相反结果：在EMERGE III期临床研究中，Aducanumab高剂量组可有效缓解患者认知下降，但在ENGAGE III期中，Aducanumab未能达到显著性差异。不过经过曲折的探索和沟通之后，美国FDA最终还是于2021年6月附条件批准了Aducanumab上市。上文所述的仑卡奈单抗可视为Aducanumab的升级版。Aducanumab的临床数据来源：中信建投证券事实上，在Aducanumab与仑卡奈单抗之外，还有一款来自礼来的多奈单抗（Donanemab）更受瞩目。John R.Sims团队在2023年阿尔茨海默病协会国际会议（AAIC）上宣布，Donanemab的III期临床试验TRAILBLAZER-ALZ 2取得成功，相关研究成功同步发表在顶级医学期刊《美国医学会杂志》（JAMA）上。从主要研究终点来看，在低/中水平tau病理的早期阿尔茨海默症患者中，根据整合阿尔茨海默症量表（iADRS）评分，与安慰剂治疗相比，Donanemab治疗将患者疾病进展的风险降低了35.1%；在全部人群中，Donanemab治疗将患者疾病进展的风险降低了22.3%。此外，低/中水平tau病理的早期阿尔茨海默症患者中，47%的患者在接受Donanemab治疗1年后病情稳定，而接受安慰剂治疗的患者中只有29%病情稳定。如果换算成更直观具体的数据的话，在76周时，接受Donanemab治疗的早期阿尔茨海默症患者的iADRS下降延迟了4.36个月，CDR-SB下降延迟了7.53个月。Donanemab在2023年1月份因使用药物超12个月的患者数量不足而未获得美国FDA的加速批准，目前礼来已就Donanemab在中美都递交了上市申请，有望在2024年获批上市。Donanemab与仑卡奈单抗的临床数据对比来源：华福证券研报在小分子方面，Blarcamesine是“未来之星”。Blarcamesine（ANAVEX2-73）是一款由Anavex Life Sciences开发的靶向Sigma-1的口服小分子激动剂，可有效改善神经元细胞内线粒体活化水平并改善神经炎症。目前，Blarcamesine已完成针对阿尔茨海默症的IIa期和IIb/III期临床试验，针对帕金森病痴呆的II期概念验证研究，以及针对成年Rett综合征患者的II期和III期研究。2023年12月欧洲EMA人用医药产品委员会（CHMP）宣布支持Blarcamesine在欧盟提交上市许可申请，因此，Blarcamesine有望成为新机制下的首个治疗阿尔兹海默症的小分子药物。Blarcamesine在阿尔兹海默病患者中的疗效来源：中信建投证券研报司美格鲁肽在降糖和减重领域大杀四方的时候，也不忘将触手伸向阿尔兹海默症领域。诺和诺和已开启两项全球多中心阿尔兹海默病临床，均预计纳入1840名患者，结果有望于2026年披露。根据药渡数据统计，全球阿尔兹海默病在研新药超600款，除靶向Aβ与Tau的药物路线外，还有其他很多研发路线也在不断取得进展：Semorinemab是一种人源化的抗tau IgG4单克隆抗体，由基因泰克开发；Atuzaginstat是一款牙龈菌蛋白酶（gingipain）抑制剂，可以降低牙龈卟啉单胞菌毒性，降低细菌负荷，从而改善阿尔茨海默症进展；ATH-1017是一种小分子药物，旨在增强肝细胞生长因子在其受体MET上的活性，由Athira Pharma开发；AGB101是一款低剂量的抗癫痫药物，使早期阿尔茨海默症患者海马回出现神经过度活跃的情况减弱，由AgeneBio开发等；Protollin是第一个被用于预防阿尔茨海默症的鼻腔疫苗等等。国内方面，2019年11月，国家药监局有条件批准中国海洋大学、中科院上海药物所与上海绿谷研发的甘露特纳用于治疗轻度至中度阿尔茨海默症症；在研产品中，除了恒瑞医药的SHR-1707属于Aβ抑制剂外，多数国内药企研发目前主要聚焦抑制AChE和NMDA受体。这里不得不提到通化金马的1.1类新药琥珀八氢氨吖啶片，该药物是一款AChE抑制剂。通化金马于2023年8月底召开了III期临床试验揭盲预备会，宣布正式完成盲态数据审核，通化金马的股价也由此开启了超过200%的涨幅。国内治疗阿尔茨海默症的主要在研小分子药物研发进展来源：华福证券研报结语尽管在研发方面，各种路线都在十分努力地证明自己，但从临床试验数据中我们也看到，这些都不是治疗阿尔兹海默症真正有效的药物。只因为发病机制没有搞清楚，目前所做的诸多努力仅仅只能够延缓阿尔兹海默症的进展，而不是彻底治愈。不过不必太过沮丧，在科学家的倾情努力下，曙光似乎就在眼前。后续发展如何，药渡还将持续关注。参考资料各大药企官网、年报、公告等华福证券、西南证券、中信建投证券研报等《JAMA重磅：阿尔茨海默病治疗进入新时代！Donanemab三期临床数据登顶，可将部分早期AD患者认知下降延缓35%》，奇点网，2023-7-20《减少45%认知衰退！阿尔兹海默口服小分子新药Blacamesine，有望2024年提交上市》，凯莱英要闻《国内首款阿尔茨海默病药获批，恒瑞医药、通化金马纷纷布局万亿市场》，蓝鲸财经，2023-1-11相关阅读展望2024 | RSV疫苗将迎来销量大爆发

临床3期申请上市

2023-11-16

·PRNewswire

Lighthouse Pharmaceuticals Announces FDA Approval To Proceed With Phase 2 Spring Trial Of LHP588, A Next-Generation Treatment For P. Gingivalis-positive Alzheimer's Disease

Phase 1 single ascending and multiple ascending dose studies previously completed demonstrate safety, tolerability and dosing to reach optimal target engagement SAN FRANCISCO, Nov. 16, 2023 /PRNewswire/ -- Lighthouse Pharmaceuticals, a clinical-stage biopharmaceutical company pioneering precision medicine for the treatment of Alzheimer's and other diseases of aging, today announced clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for LHP588, the company's next-generation gingipain inhibitor, for the treatment of P. gingivalis-positive Alzheimer's disease. The "Study May Proceed" letter from the FDA was based on review of the comprehensive IND package including safety, chronic toxicology, manufacturing, Phase 1 human data, and the planned Phase 2 SPRING (Stopping PRogression of P. gINGivalis-positive Alzheimer's disease) trial protocol. LHP588 is a next-generation, brain penetrant small-molecule gingipain inhibitor that demonstrated safety and tolerability in the completed Phase 1 study, along with plasma levels sufficient to engage the target with just once-daily oral dosing. The Phase 2 SPRING clinical trial is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of once-a-day dosing of LHP588 for the treatment of P. gingivalis-positive mild to moderate Alzheimer's disease. 300 patients will be enrolled in the trial and randomized into three arms (placebo, 25 and 50 mg) for 48 weeks of treatment. Patients must have mild to moderate Alzheimer's disease and evidence of P. gingivalis infection, based on a saliva test. The GAIN trial of the first-generation gingipain inhibitor, atuzaginstat, demonstrated that patients with mild to moderate AD and a positive P. gingivalis saliva test had a dose-dependent, 57% slowing of cognitive decline on the prespecified proof of efficacy endpoint, ADAS-Cog11, compared to the placebo group (p = 0.02). "We are very pleased to have FDA clearance to initiate the SPRING Phase 2 clinical trial. Previous studies of this mechanism indicated promise of the precision medicine approach being leveraged by Lighthouse going forward. The clinical efficacy and safety data provided by the GAIN trial has enabled us to significantly de-risk the mechanism of action, maximize target engagement with higher exposures of LHP588, and implement the optimal clinical study design," said Casey Lynch, CEO of Lighthouse Pharmaceuticals. "LHP588 is a next-generation gingipain inhibitor that has been optimized for selectivity and metabolism, demonstrating an excellent safety profile in both human and toxicology studies. With FDA clearance in hand, we look forward to working with our clinical advisors and investors to move this important clinical study forward." About Lighthouse Pharmaceuticals Lighthouse Pharma is a clinical stage private biopharmaceutical company pioneering precision medicine approaches to major unmet medical needs based on expertise in small molecule protease inhibition. Lighthouse's lead program, LHP588, a Phase 2 ready orally bioavailable small molecule, targets a specific, infectious pathogen, Porphyromonas gingivalis, which is associated with chronic degenerative and inflammatory disorders including dementia, periodontal disease, atherosclerosis, and orodigestive cancers. For more information, visit . SOURCE Lighthouse Pharmaceuticals

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适应症	最高研发状态	国家/地区	公司	日期
阿尔茨海默症	临床3期	美国	Quince Therapeutics, Inc.	2019-03-28
阿尔茨海默症	临床3期	法国	Quince Therapeutics, Inc.	2019-03-28
阿尔茨海默症	临床3期	荷兰	Quince Therapeutics, Inc.	2019-03-28
阿尔茨海默症	临床3期	波兰	Quince Therapeutics, Inc.	2019-03-28
阿尔茨海默症	临床3期	西班牙	Quince Therapeutics, Inc.	2019-03-28
阿尔茨海默症	临床3期	英国	Quince Therapeutics, Inc.	2019-03-28
帕金森病	临床前	美国	Quince Therapeutics, Inc.	2021-01-12

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03823404 (CTgov)	临床2/3期	阿尔茨海默症	643	COR388 (COR388 80 mg BID (Twice Daily))	範艱選壓觸齋廠夢窪構(築願餘廠淵觸窪觸鬱願) = 鑰願蓋簾醖繭鏇鏇網夢構鏇餘範壓醖網膚夢衊 (簾醖艱鹽憲淵顧築繭窪, 觸壓觸鹹遞鑰顧鬱鑰鹹 ~ 遞獵獵淵鬱壓齋糧壓選) 更多	-	2023-02-23
				COR388 (COR388 40 mg BID (Twice Daily))	範艱選壓觸齋廠夢窪構(築願餘廠淵觸窪觸鬱願) = 廠夢觸製製顧廠廠壓遞構鏇餘範壓醖網膚夢衊 (簾醖艱鹽憲淵顧築繭窪, 鬱鏇廠鹽積襯衊艱糧網 ~ 襯製廠艱觸夢顧廠觸餘) 更多