A 6-month & 18-month Prospective, Randomized, Placebo-controlled, Double-blind Dual Clinical Trial Investigating Efficacy and Safety of Buntanetap in Treating Participants of Early Alzheimer's Disease

The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are:
* Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13?
* Does buntanetap/Posiphen improve function as measured by ADCS-iADL?
* What medical issues do participants have, if any, when taking buntanetap/Posiphen?
Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease.
Participants will:
* Take buntanetap/Posiphen or a placebo every day for 18 months
* Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18
* Complete pre- and post-clinic visit phone calls

开始日期2025-02-01

申办/合作机构

Annovis Bio, Inc.

[+1]

NCT05686044

/ Completed临床2/3期

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study of Buntanetap in Participants With Mild to Moderate Alzheimer's Disease

The purpose of this study is to measure efficacy and safety of three different doses of buntanetap/Posiphen compared with placebo in participants with mild to moderate Alzheimer's disease.
Study details include:
The double-blind treatment duration will include a screening period of up to 42 days followed by 12 weeks of treatment at home.
The study duration will be 4-5 months. There will be 4 in-clinic visits and 1 phone call.

开始日期2023-04-01

申办/合作机构

Annovis Bio, Inc.

NCT05357989

/ Completed临床3期

A 6-month Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Efficacy, Safety, and Tolerability of Two Different Doses of Buntanetap or Placebo in Patients With Early Parkinson's Disease

The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules compared with placebo capsules in participants with early PD.
Study details include:
* The study duration will be up to 7-8 months.
* The double-blind treatment duration will be up to 6 months.
* There will be 5 in-clinic visits and 7 phone calls

开始日期2022-08-03

申办/合作机构

Annovis Bio, Inc.

[+1]

100 项与 Buntanetap 相关的临床结果

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100 项与 Buntanetap 相关的转化医学

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100 项与 Buntanetap 相关的专利（医药）

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项与 Buntanetap 相关的文献（医药）

2024-04-01·SLAS discovery : advancing life sciences R & D

Real-time thiol detection in iPSC-derived neuron cultures using SemKur-IM, a novel fluorescent dithio probe

Article

作者: Alvarez, Roxanne ; Sem, Daniel S ; Kurfis, Jayson ; Hendrickson, Michael

Neurological disorders associated with inflammation and oxidative stress show reduced glutathione (GSH) levels in the human brain. Drug discovery efforts and pharmacological studies would benefit from tools (e.g. chemical probes) that detect changes to oxidative stress, from the perspective of physiologically-relevant reporters like cellular thiols, including GSH. To this end, we have developed a fluorescence visualization assay using iPSC-derived cortical glutamatergic neurons that were loaded with 25 μM of a novel thiol-detection fluorescent probe, SemKur-IM. This probe enables visualization of cellular thiol level changes in the neuronal somas and neurites, in response exposure to N-acetyl-cysteine (NAC). Cellular thiol redox state was observed to change, based on an increase in green fluorescence (485 nm excitation maximum; 525 nm emission maximum) due to changes in thiol levels, from 0 to 40 mM. Interestingly, prior to treatment with NAC, cells did not appear to have significant levels of reduced thiols. Our studies demonstrate the utility of SemKur-IM in the detection of thiol levels in live cells in response to chemical exposures, such as from drugs that return the cell to a healthier reduced state. An initial application to screening the effects of an Alzheimer's disease drug candidate, Posiphen, using fluorescence cell sorting is presented. Other potential applications include high throughput screening of central nervous system (CNS) drugs thought to work by affecting cellular redox state in neurons.

2023-01-01·The journal of prevention of Alzheimer's disease

Buntanetap, a Novel Translational Inhibitor of Multiple Neurotoxic Proteins, Proves to Be Safe and Promising in Both Alzheimer's and Parkinson's Patients

Article

作者: Hernandez, P ; Liow, K ; Feng, D ; Maccecchini, M ; Fang, C ; Damiano, E ; Blennow, K ; Zetterberg, H ; Chen, M

BACKGROUND:

Previously we reported the clinical safety and pharmacological activity of buntanetap (known as Posiphen or ANVS401) in healthy volunteers and mild cognitive impaired (MCI) patients (21). The data supported continued clinical evaluation of buntanetap for treating Alzheimer's Disease (AD). Neurodegenerative diseases such as AD and Parkinson's disease (PD) share several pathological manifestations, including increased levels of multiple neurotoxic protein aggregates. Therefore, a treatment strategy that targets toxic species common to both disorders can potentially provide better clinical outcomes than attacking one neurotoxic protein alone. To test this hypothesis, we recently completed a clinical study in early AD and early PD participants and report the data here.

OBJECTIVES:

We evaluated safety, pharmacokinetics, biomarkers, and efficacy of buntanetap in treating early AD and PD patients.

DESIGN:

Double-blind, placebo-controlled, multi-center study.

SETTING:

13 sites in the US participated in this clinical trial. The registration number is NCT04524351 at ClinicalTrials.gov.

PARTICIPANTS:

14 early AD patients and 54 early PD patients.

INTERVENTION:

AD patients were given either 80mg buntanetap or placebo QD. PD patients were given 5mg, 10mg, 20mg, 40mg, 80mg buntanetap or placebo QD.

MEASUREMENTS:

Primary endpoint is safety and tolerability; secondary endpoint is pharmacokinetics of buntanetap in plasma; exploratory endpoints are 1) biomarkers in cerebrospinal fluid (CSF) in both AD and PD patients 2) psychometric tests specific for AD (ADAS-Cogs and WAIS coding test) or PD (MDS-UPDRS and WAIS coding test).

RESULTS:

Buntanetap was safe and well tolerated. Biomarker data indicated a trend in lowering levels of neurotoxic proteins and inflammatory factors and improving axonal integrity and synaptic function in both AD and PD cohorts. Psychometric tests showed statistically significant improvements in ADAS-Cog11 and WAIS coding in AD patients and MDS-UPDRS and WAIS coding in PD patients.

CONCLUSIONS:

Buntanetap is well tolerated and safe at doses up to 80mg QD in both AD and PD patients. Cmax and AUC increase with dose without evidence for a plateau up to 80mg QD. The drug shows promising evidence in exploratory biomarker and efficacy measures. Further evaluation of buntanetap in larger, longer-term clinical trials for the treatment of AD and PD are warranted.

2022-02-11·ACS pharmacology & translational science

In Silico and Ex Vivo Analyses of the Inhibitory Action of the Alzheimer Drug Posiphen and Primary Metabolites with Human Acetyl- and Butyrylcholinesterase Enzymes

Article

作者: Furqan, Tiyyaba ; Tweedie, David ; Greig, Nigel H. ; Hasan Mahmood, Muhammad Sibte ; Kamal, Mohammad A. ; Batool, Sidra

Alzheimer's disease (AD) is the most common neurodegenerative disorder worldwide. Ongoing research to develop AD treatments has characterized multiple drug targets including the cholinergic system, amyloid-β peptide, phosphorylated tau, and neuroinflammation. These systems have the potential to interact to either drive or slow AD progression. Promising agents that simultaneously impact many of these drug targets are the AD experimental drug Posiphen and its enantiomer phenserine that, currently, are separately being evaluated in clinical trials. To define the cholinergic component of these agents, the anticholinesterase activities of a ligand dataset comprising Posiphen and primary metabolites ((+)-N1-norPosiphen, (+)-N8-norPosiphen, and (+)-N1,N8-bisnorPosiphen) were characterized and compared to those of the enantiomer phenserine. The "target" dataset involved the human cholinesterase enzymes acetylcholinesterase (AChE) and butyrylcholinesterase (BChE). Binding interactions between the ligands and targets were analyzed using Autodock 4.2. The computationally determined inhibitory action of these ligands was then compared to ex vivo laboratory-measured values versus human AChE and BChE. While Posiphen lacked AChE inhibitory action, its major and minor metabolites (+)-N1-norPosiphen and (+)-N1,N8-bisnorPosiphen, respectively, possessed modest AChE inhibitory activity, and Posiphen and all metabolites lacked BChE action. Phenserine, as a positive control, demonstrated AChE-selective inhibitory action. In light of AChE inhibitory action deriving from a major and minor Posiphen metabolite, current Posiphen clinical trials in AD and related disorders should additionally evaluate AChE inhibition; particularly if Posiphen should be combined with a known anticholinesterase, since this drug class is clinically approved and the standard of care for AD subjects, and excessive AChE inhibition may impact drug tolerability.

116

项与 Buntanetap 相关的新闻（医药）

2025-02-04

·GlobeNewswire-Health Care

Annovis Bio, Inc. Announces Closing of $21 Million Public Offering

MALVERN, PA, Feb. 04, 2025 (GLOBE NEWSWIRE) -- via IBN - Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced the closing of its previously announced underwritten public offering of 5,250,000 shares of common stock and warrants to purchase 5,250,000 shares of common stock at a combined public offering price of $4.00 per share and associated warrant. The warrants have an exercise price of $5.00 per share and are immediately exercisable upon issuance for a period of five years following the date of issuance. Total gross proceeds from the offering, before deducting the underwriter’s discounts and other offering expenses, were $21 million. The Company intends to use the net proceeds from the offering primarily for the continued clinical development of the Company’s lead compound, Buntanetap in a Phase 3 study for Alzheimer’s disease, and for working capital and general corporate purposes. ThinkEquity acted as the sole book-running manager for the offering. The securities were offered and sold pursuant to a shelf registration statement on Form S-3, as amended (File No. 333-276814), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 1, 2024, and declared effective on February 12, 2024. The offering was made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering have been filed with the SEC on its website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Annovis Bio, Inc. Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X. Forward Looking StatementsThis press release contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company’s plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of Buntanetap, and the timing, effectiveness, and anticipated results of the Company’s clinical trials evaluating the efficacy, safety, and tolerability of Buntanetap. Additional risk factors are detailed in the Company’s periodic filings with the SEC, including those listed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements in this press release are based on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Contact:Annovis Bio Inc. 101 Lindenwood Drive Suite 225 Malvern, PA 19355 www.annovisbio.com Investor Contact:Scott McGowanInvestorBrandNetwork (IBN)Phone: 310.299.1717www.annovisbio.com/investors-relationsIR@annovisbio.com

临床3期

2025-01-14

·GlobeNewswire-Health Care

Annovis Granted U.S. Patent for Treatment and Prevention of Acute Brain or Nerve Injuries Securing Global Protection

MALVERN, Pa, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced it was granted the U.S. patent covering methods for the treatment and prevention of acute brain or nerve injuries using buntanetap. This newly issued patent is based on buntanetap’s ability to reduce neurotoxicity and mitigate neurodegenerative processes, which can be applicable to such conditions as stroke, ischemia, traumatic brain injury, micro infarcts, and other forms of acute injuries. The patent has already been granted in the EU, Japan, and worldwide. With this latest approval in the U.S., the company now holds global protection for the use of buntanetap in treating acute neurodegenerative disorders. “Nerve cells are inherently delicate and susceptible to structural damage upon physical impact. Buntanetap works by targeting the neurotoxic pathways that contribute to this damage, providing a potential path to protect and restore neuronal health,” commented Maria Maccecchini, Ph.D., Founder, President and CEO of Annovis. “We are proud to add this patent to our growing intellectual property portfolio, further expanding the possible applications of buntanetap beyond its primary indications such as Alzheimer’s and Parkinson’s diseases.” The U.S. Patent and Trademark Office (USPTO) issued the patent on January 2, 2025, under the publication number US-2025-0000846-A1. About Annovis Bio Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X. Investor Alerts Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at https://www.annovisbio.com/email-alerts. Additionally, we invite you to explore our updated investor website, which provides comprehensive access to company news, financial reports, and other key information. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company's plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of Buntanetap, and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety, and tolerability of Buntanetap. Additional risk factors are detailed in the Company's periodic filings with the SEC, including those listed in the "Risk Factors" section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements in this press release are based on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Contact Information:Annovis Bio Inc.101 Lindenwood DriveSuite 225Malvern, PA 19355www.annovisbio.com Investor Contact:Scott McGowanInvestorBrandNetwork (IBN)Phone: 310.299.1717www.annovisbio.com/investors-relationsIR@annovisbio.com

上市批准

2025-01-02

·贝壳社

CNS新药即将迎来大爆发时代

▲点击图片，了解详情作者：黄仲平随着社会的前进和生活质量的提升，人类的预期寿命在不断增长，老龄化的步伐也在加快，随之而来的是中枢神经系统（CNS）疾病的发病率也在逐步上升，如帕金森病和阿尔兹海默症等老年性疾病对人类的健康和生活质量构成了严重威胁。同时，生活节奏的加快和竞争的加剧带来了更大的精神压力，这导致了失眠和抑郁症等精神障碍的发病率急剧增加。不断上升的患病数量为全球中枢神经类药物市场不断扩容，正在催化越来越多的CNS新药诞生。遗忘得到减缓对中国的阿尔茨海默症患者来说，2024年是个幸运年：年初，卫材的仑卡奈单抗（Lecanemab）登场；年末，礼来的多奈单抗（Donanemab）获批。不过这也意味着，仑卡奈单抗和多奈单抗将在中国市场产生正面碰撞，谁能更胜一筹？仑卡奈单抗针对早期阿尔兹海默症的Ⅲ期试验结果显示：接受治疗18个月后，仑卡奈单抗组和安慰剂组的临床痴呆评分总和（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%。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。多奈单抗的III期临床研究TRAILBLAZER-ALZ 2结果显示：与安慰剂组相比，接受多奈单抗治疗组患者的综合阿尔茨海默病评定量表（iADRS）评分下降速度减缓了35%，临床痴呆评定量表总和评分（CDR-SB）较安慰剂组下降速度减缓了36%，并且阿尔茨海默病合作研究日常生活活动量表（ADCS iADL）评分显示疾病进展速度延缓了40%。单纯从数据上看，两者并没有特别显著的差异。全球市场中，还有一款阿杜卡尼单抗（Aducanumab）于2021年6月获美国FDA批准上市。但阿杜卡尼单抗商业化表现远低于市场预期，2021年和2022年销售额仅有300万美元和480万美元。雪上加霜的是，多奈单抗在头对头试验中击败了阿杜卡尼单抗，几乎截断了其商业化前景。阿杜卡尼单抗、仑卡奈单抗和多奈单抗临床数据对比，来源：太平洋证券研报这三款近年诞生的阿尔茨海默症新药均为Aβ单克隆抗体，使得以β-淀粉样蛋白斑块为靶点的治疗策略成为主流。但这并不意味着这一路线就是绝对正确。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。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、Tau蛋白异常磷酸化假说和胆碱能假说。三大假说均出现了多条针对性的技术路线。据统计，全球阿尔兹海默病在研新药超600款，多路线正在齐头并进。 Remternetug是礼来的一款给药方式灵活的靶向N3pG淀粉样蛋白亚型的抗体药物；ALZ-801是Alzheon研发的一款针对淀粉样蛋白聚集和神经毒性的口服小分子抑制剂；Galectin-3是TrueBinding研发的一种可溶性的β-半乳糖苷结合蛋白；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开发等等等等。国内方面，2019年11月上海绿谷研发的甘露特纳获批上市，通化金马的1.1类新药AChE抑制剂琥珀八氢氨吖啶已提交NDA。除此之外，国内自研生物创新药和化学创新药多数尚处于早期临床阶段，研发靶点也呈现多样化态势，并且出现了中药产品。恒瑞医药的国产Aβ单抗SHR-1707处于Ib期临床；先声药业从Vivoryon Therapeutics引进的一种靶向神经毒性淀粉样蛋白N3pE(pGlu-Aβ)的口服小分子谷氨酰肽环转移酶（QPCT）抑制剂处于临床Ⅱb期；康弘药业的6.1类中药创新药KH110（五加益智颗粒）处于临床Ⅱ期；悦康药业的中药1.1类新药复方银杏叶片进入NDA阶段...... 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。道路总是曲折的，随着越来越多的新药上市，曙光似乎就在眼前。颤抖得到减轻帕金森病是继阿尔茨海默症后第二常见的神经系统退行性疾病，主要以黑质多巴胺能神经元进行性退变和路易小体形成的病理变化，以及纹状体区多巴胺递质降低、多巴胺与乙酰胆碱递质失平衡的生化改变为显著特征。临床主要表现为震颤、肌强直、动作迟缓、姿势平衡障碍的运动症状和睡眠障碍、嗅觉障碍、自主神经功能障碍、认知和精神障碍等非运动症状。流行病学调查研究显示欧美国家60岁以上帕金森病患病率达到1%，80岁以上超过4%，我国65岁以上人群患病率为1.7%。迄今为止，帕金森病的治疗仅能改善症状，无法阻止病情发展。由于目前帕金森病发病机制并不明确，因此对帕金森病研发也存在多种技术路线之争，主要包括对症治疗（ST）路线和疾病修饰疗法（DMT）路线。全球范围内，帕金森病在研管线阶段及靶点分类，来源：太平洋证券研报从靶点分类看，对症治疗（ST）仍以多巴胺能靶点为主，目前有多个在研处于III期阶段，其中艾伯维开发的ABBV-951（foslevodopa/foscarbidopa）和Cerevel开发的Tavapadon关注度较高。 ABBV-951是一款左旋多巴和卡比多巴前体药物，可显著改善晚期帕金森病患者的运动并发症，已于2024年10月获美国FDA批准上市，是首款基于左旋多巴的24小时皮下连续输注疗法；Tavapadon为一款高选择性D1/D5受体部分激动剂，有潜力成为早期帕金森病单药治疗和晚期帕金森病辅助治疗药物。随着对帕金森病发病机制的深入研究，疾病修饰疗法（DMT）逐渐成为近年来新药研发的热点。其中也存在多种不同方向技术路线，包括的对热门靶点α-突触核蛋白（α-syn）的研究，以及细胞疗法、肠道菌群疗法、GLP-1受体激动剂等。 Buntanetap是Annovis Bio开发的一种可阻断mRNA翻译表达神经毒性蛋白的小分子抑制剂；IKT-148009是一种小分子c-Abl激酶抑制剂，可降低c-Abl激酶的活性；Lu AF82422是一种靶向α-syn C末端的人免疫球蛋白G1（IgG1）单克隆抗体；BIIB122是Denali开发的一款小分子LRRK2激酶抑制剂...... 国内方面，目前已有多款创新制剂上市，以及超21款帕金森病在研新药物。其中以跃赛生物的干细胞技术和恒瑞医药的双基因药物最为受关注。跃赛生物自主研发针对帕金森病的iPSC来源细胞药物产品UX-DA001注射液（人中脑多巴胺能神经前体细胞注射液）获得CDE的临床试验默示许可，成功进入临床试验阶段，这一突破标志着国内在神经退行性疾病治疗领域的一项重要进展。 RGL-193是恒瑞医药自主研发的一款候选双基因AAV治疗药物，采用立体定向技术注入患者脑内，提高左旋多巴的转化效率，目前已完成首例患者给药。从市场规模看，目前国内帕金森病仅30余亿元，对标发达国家，渗透率有非常大的增长空间。随着人口老龄化程度持续加深，帕金森病患者人数将快速增加，具有明确疗效的新药不断获批，市场规模或将迎来大规模跃升。新机制药物接二连三诞生在治疗手段上，与肿瘤、自身免疫性疾病等相比，CNS领域药物研发进度缓慢。但如上文所述，阿尔茨海默病、帕金森病等领域近年来逐渐出现新机制药物获批，研发困境逐步反转，精神分裂症、抑郁症、偏头痛、失眠等领域都迎来或正在迎来诸多突破性进展。精神分裂症方面，新机制药物KarXT于2024年9月成功获得美国FDA批准，标志着精神分裂症治疗正式进入“后多巴胺”时代。KarXT是继20世纪50年代初第一代抗精神病药氯丙嗪诞生后，70年来首款采用全新作用机制的抗精神病药物。 KarXT最初由Karuna研发，制药巨头BMS看到了这款药物的潜力，于2023年底以140亿美元价格收购Karuna，再鼎医药拥有KarXT的大中华区权益，并正在参与其多个全球临床研究。抑郁症方面，近年来同样有所突破，临床上有探索新机制和在传统分子上进行再开发的策略。这其中，来自国内制药企业绿叶制药的托鲁地文拉法辛的获批，创造了国产创新药在抑郁症治疗领域取得的里程碑式的“零”的突破。新机制的探索路径上，针对单胺通路，COMPASS Pathways开发了针对受体的激动剂COMP360；NMDA拮抗剂带代表药物有安非他酮和右美沙芬的复方制剂Auvelity等。失眠治疗药物方面，新靶点药物上市速度正在加快，成功开发的有食欲素受体拮抗剂和GABAA正向调节剂。食欲素受体拮抗剂代表药物有默沙东的苏沃雷生，Idorsia的Daridorexant；GABAA正向调节剂代表药物有京新药业的地达西尼，于2023年国内获批上市，服用后平均睡眠时间均可延长，不改变睡眠结构，且未发现依赖性、反跳性失眠、戒断症状和药物滥用证据。结语由于中枢神经系统不具有再生能力，加之对神经元运作的机制了解并不全面，这也造成了中枢系统疾病新药研发的难度。但自2022年起，CNS领域新机制研发药物日臻成熟，引起了MNC的强烈关注，开始逐步加码CNS领域的收购和BD，除上文提到的BMS收购Karuna外，辉瑞、艾伯维、默沙东等均现大额并购案，眼见着CNS领域的一场争夺战即将打响。国内布局了CNS研发的药企，如翰森制药、绿叶制药或许有望乘风而上。后续发展如何，贝壳社还将持续关注。参考资料： 1、各大上市公司官网、公告、年报等 2、太平洋证券、招商证券、智银资本等研报 3、《CNS的冰与火之歌》，氨基观察，2024-12-25 4、《每4周注射一次！礼来阿尔茨海默病新药在国内获批》，人民日报，2024-12-18 5、《全国首款！全球第二款!保税区域生物医药产业又传喜报》，上观，2024-12-25 关于贝壳社贝壳社是国内领先的医健创新创业服务平台，为医健创业者提供全路径创业服务。通过产业空间运营、创业教育、投资孵化、数字化赋能、企业价值增长等服务体系，给医健创业企业提供产业空间、人才战略培养、投融资、产业生态资源、数字化转型等服务。同时，贝壳社布局澳洲，帮助国内生物医药企业加速走向海外；成立“泰格-泰珑-贝壳社企业经营服务中心”为企业成长提供全生命周期的增值服务，提高企业运营效率，加快企业成长发展。我们深度链接政府、科研院所、临床机构、投资机构、第三方服务商、CXO等行业资源，致力于赋能医疗健康创业公司成长，推动创新技术造福人类生命健康。往期推荐 1 越来越多Biotech发起“独立宣言” 2 多抗：下一个大药发展趋势 _ 3 围猎60亿美元大药 _ *声明：本文仅为作者观点，不构成任何投资建议，且非治疗方案推荐。投稿请添加小助手：bioclub666

上市批准临床3期抗体药物偶联物临床结果临床成功

100 项与 Buntanetap 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15317

研发状态

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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	Annovis Bio, Inc.	2025-02-01
帕金森病	临床3期	美国	Annovis Bio, Inc.	2022-08-03
帕金森病	临床3期	德国	Annovis Bio, Inc.	2022-08-03
帕金森病	临床3期	匈牙利	Annovis Bio, Inc.	2022-08-03
帕金森病	临床3期	意大利	Annovis Bio, Inc.	2022-08-03
帕金森病	临床3期	波兰	Annovis Bio, Inc.	2022-08-03
帕金森病	临床3期	西班牙	Annovis Bio, Inc.	2022-08-03
帕金森病（青年型、早发型）	临床2期	美国	Annovis Bio, Inc.	2020-08-14
认知功能障碍	临床2期	美国	Annovis Bio, Inc.	2009-05-26
路易体病	临床2期	-	Annovis Bio, Inc.	-

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临床结果

适应症

分期

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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


NCT05357989 (CTgov)	临床3期	帕金森病	523	Placebo (Placebo)	鹽顧獵衊鑰築夢餘鹽選(簾襯襯衊窪淵窪觸鏇壓) = 艱築選遞顧製襯壓製夢顧網蓋壓衊廠網製襯餘 (襯簾觸糧壓壓構積憲鬱, 糧觸淵醖鬱鑰簾積構範 ~ 製鏇壓醖簾範膚廠壓鹽) 更多	-	2025-03-03
				buntanetap/posiphen (10 mg Buntanetap/Posiphen)	鹽顧獵衊鑰築夢餘鹽選(簾襯襯衊窪淵窪觸鏇壓) = 網築顧艱鬱夢鏇憲鹽構顧網蓋壓衊廠網製襯餘 (襯簾觸糧壓壓構積憲鬱, 窪廠築範淵廠構餘鏇繭 ~ 衊艱壓願鹹鹹願餘顧簾) 更多
NCT05357989 (Biospace) 人工标引	临床3期	帕金森病	-	Buntanetap	築網憲鹹夢積鬱膚艱觸(選憲壓餘壓齋壓鏇壓艱) = In patients diagnosed with PD for longer than 3 years (MH>3), with measurable declines in MDS-UPDRS Part II, 20mg buntanetap significantly improved MDS-UPDRS Part II, Part III, Part II+III, and Total scores compared to placebo and baseline 獵願夢蓋觸醖窪齋觸鏇 (憲積齋鹹齋選襯窪衊網 ) 更多	积极	2024-07-02
				Placebo
GlobeNewswire 人工标引	N/A	阿尔茨海默症	-	Buntanetap 15mg	鏇淵選窪構簾觸壓鏇顧(廠蓋膚範壓憲選淵鏇醖) = 憲齋願齋廠憲艱憲鹹顧觸鏇顧鹽膚簾鬱醖膚構 (獵觸醖夢憲壓製遞繭蓋 )	积极	2024-06-11
				Placebo	鏇淵選窪構簾觸壓鏇顧(廠蓋膚範壓憲選淵鏇醖) = 鬱淵製艱壓築衊鹹膚艱觸鏇顧鹽膚簾鬱醖膚構 (獵觸醖夢憲壓製遞繭蓋 )
NCT05686044 (Biospace) 人工标引	临床2/3期	阿尔茨海默症	325	Buntanetap 7.5 mg	淵廠襯膚淵製夢繭願繭(鏇獵鬱壓鹽顧構壓艱築) = 醖製鏇糧選艱選餘鹹選餘餘獵願製淵鏇築衊簾 (製顧範選蓋築願衊糧築, 0.87)	积极	2024-05-29
				Buntanetap 15 mg	淵廠襯膚淵製夢繭願繭(鏇獵鬱壓鹽顧構壓艱築) = 襯鬱願鏇醖製齋糧鏇觸餘餘獵願製淵鏇築衊簾 (製顧範選蓋築願衊糧築, 0.81)
NCT05686044 (Biospace) 人工标引	临床2/3期	阿尔茨海默症	107	Buntanetap	構鏇糧憲觸廠構鬱鹽鏇(範醖膚衊選夢夢範觸遞) = 範繭夢淵網遞鹹膚窪壓鬱製鏇構選憲製遞糧繭 (夢窪鏇壓獵築製壓遞積 )	积极	2023-10-30
NCT04524351 (CTgov)	临床1/2期	帕金森病（青年型、早发型） \| 阿尔茨海默症	75	Posiphen (Posiphen, 80mg (Parkinson's Participants))	齋艱構範艱壓鑰夢衊壓(鑰觸襯願憲淵構餘構餘) = 廠夢築繭遞積繭構膚艱繭繭憲窪遞餘蓋夢網餘 (繭艱繭淵築遞膚觸築蓋, 廠艱蓋範網窪襯衊蓋鑰 ~ 願夢淵遞廠餘餘壓積獵) 更多	-	2023-02-28
				Posiphen (Posiphen, 40mg (Parkinson's Participants))	齋艱構範艱壓鑰夢衊壓(鑰觸襯願憲淵構餘構餘) = 顧選鏇齋觸壓構夢淵獵繭繭憲窪遞餘蓋夢網餘 (繭艱繭淵築遞膚觸築蓋, 餘顧觸廠顧製獵齋壓淵 ~ 糧襯膚遞繭膚繭齋構壓) 更多
NCT02925650 (CTAD2022)	临床1期	轻度认知障碍 CSF Aβ42/40	19	Posiphen	願構範廠壓構積艱鹽繭(糧鏇夢艱襯醖選選獵觸) = 8/19 participants reported headache either during CSF sampling (4),after the procedure (3), or both (1). 5 had blood patches with rapid resolution of headache. 鑰衊觸鹽觸簾餘餘範獵 (願遞壓顧餘範壓壓糧窪 )	-	2022-12-03