A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathies

This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.

开始日期2024-11-11

申办/合作机构

Longboard Pharmaceuticals, Inc.

NCT06660394

/ Recruiting临床3期

This (DEEp SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.

开始日期2024-10-02

申办/合作机构

Longboard Pharmaceuticals, Inc.

NCT05626634

/ Completed临床2期

A Phase 2, Multicenter, Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy Who Completed Study LP352-201 and Are Candidates for Continuous Treatment for Up to 52 Weeks

The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201.

开始日期2022-11-08

申办/合作机构

Longboard Pharmaceuticals, Inc.

100 项与 Bexicaserin 相关的临床结果

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100 项与 Bexicaserin 相关的转化医学

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100 项与 Bexicaserin 相关的专利（医药）

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项与 Bexicaserin 相关的文献（医药）

2025-02-01·BIOMEDICAL CHROMATOGRAPHY

A Highly Sensitive Triple Quad LC–MS/MS Method Development and Validation for the Determination of Bexicaserin (LP352) in Human Plasma and Urine Matrices

Article

作者: Neal, Katie ; Yeager, Maisy ; Srinivas, Nuggehally R. ; Fletcher, Katharine ; Chan, Rosa ; Kallem, Raja Reddy

ABSTRACT:

Bexicaserin is a highly selective agonist at the 5‐HT2c receptor in clinical development for the treatment of seizures associated with developmental and epileptic encephalopathies (DEEs). We report an LC–MS/MS method for the quantitative estimation of bexicaserin in human plasma and urine. The sample preparation involves the extraction of bexicaserin and internal standard (13CD2‐bexicaserin; IS) from 150 μL plasma and 50 μL urine using a solid phase extraction method. The chromatographic separation of bexicaserin and IS was achieved on a Poroshell EC‐C18 column using 5 min gradient program. The calibration curve ranged from 0.1 to 100 ng/mL in plasma and 1.0 to 1000 ng/mL in urine. Intraday and interday precision and accuracy, linearity, matrix effect, extraction recovery, carry‐over, dilution integrity, a battery of stability studies, and incurred sample reanalysis were performed for bexicaserin in both plasma and urine. The intraday and interday accuracy and precision were well within the acceptable limits in both plasma and urine matrices. Stability studies in plasma and urine showed that bexicaserin was stable on bench for 24 h, in autosampler over 54 h, five freeze–thaw cycles, and long‐term storage at −20°C and −80°C for > 368 days. The validated methods were successfully applied in clinical study.

2025-01-01·JOURNAL OF THE INDIAN CHEMICAL SOCIETY

Synthesis of magnesium oxide nanoparticles via hydrothermal and sol-gel methods: Charaterization and their application for H2S and NO2 gas sensing

作者: Gurule, Akanksha Changdeo ; Shinde, Vrushali Shyamrao ; Gaikwad, Sharad Shankar ; Jadhav, Ghanshyam Ratan ; Gaikwad, Vishwasrao Bhaskarrao ; Kajale, Dynaneshwar Dattu

Magnesium oxide nanoparticles (MgO NPs) are particularly appealing for scientific investigation due to their numerous uses in optical devices, catalysis, and gas sensing.This study describes the synthesis of pure MgO NPs using two active methods: hydrothermal and sol-gel.The work analyzes different synthesis methods, emphasizing such critical factors as reaction time, mole ratio, calcination temperature, synthesis temperature, and solvent selection for the hydrothermal process.Variations in these parameters have a major impact on MgO NPs' sensing capabilities.The constructed MgO NPs were characterized by XRD, UV-visible spectroscopy, FTIR, SEM-EDAX.The synthesis approach was convenient and effective, producing particles with average crystallite sizes ranging from 10 nm to 25 nm.The MgO band gap was optimized between 3 and 4 eV.A gas sensing unit was used to investigate the sensing properties of several gases, including ammonia, CO2, LPG, NO2, SO2, and H2S.Hydrothermally produced MgO NPs were very sensitive to H₂S gas, with the most significant reaction revealed when propanol was used as the solvent.MgO NPs produced by the sol-gel technique, on the other hand, displayed improved NO₂ gas sensitivity.

2024-10-01·EPILEPSIA

Progress report on new medications for seizures and epilepsy: A summary of the 17th Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XVII). II. Drugs in more advanced clinical development

Article

作者: White, H. Steve ; Johannessen, Svein I. ; Perucca, Emilio ; Tomson, Torbjörn ; Koepp, Matthias J. ; Bialer, Meir ; Perucca, Piero

Abstract:

The 17th Eilat Conference on New Antiepileptic Drugs and Devices took place in Madrid, Spain on May 5–8, 2024. As usual, the core part of the conference consisted of presentations on investigational drugs at various stages of development for epilepsy‐related indications. Summaries of information on compounds in preclinical or early clinical development are included in an accompanying publication (Part I). In this article, we provide summaries for five compounds in more advanced clinical development, i.e. compounds for which some information on antiseizure activity in individuals with epilepsy is available. These investigational treatments include azetukalner (XEN1101), a potent, KV7.2/7.3‐specific potassium channel opener in development for the treatment of focal seizures, generalized tonic–clonic seizures, and major depressive disorder; bexicaserin (LP352), a selective 5‐HT2C receptor superagonist in development for the treatment of seizures associated with developmental and epileptic encephalopathies; radiprodil, a selective negative allosteric modulator of NR2B subunit‐containing N‐methyl‐D‐aspartate glutamate receptors, in development for the treatment of seizures and behavior manifestations associated with disorders caused by gain‐of‐function mutations in the GRIN1, −2A, ‐2B, or ‐2D genes; soticlestat (TAK‐935), a selective inhibitor of cholesterol 24‐hydroxylase in development for the treatment of seizures associated with Dravet syndrome and Lennox–Gastaut syndrome; and STK‐001, an antisense oligonucleotide designed to upregulate Nav1.1 protein expression and improve outcomes in individuals with Dravet syndrome. The diversity in mechanisms of action of these agents illustrates different approaches being pursued in the discovery of novel treatments for seizures and epilepsy. For two of the compounds discussed in this report (azetukalner and soticlestat), clinical evidence of efficacy has already been obtained in a randomized placebo‐controlled adjunctive‐therapy trial. For the other compounds, adequately powered placebo‐controlled efficacy trials have not been completed to date.

项与 Bexicaserin 相关的新闻（医药）

2025-01-29

·药事纵横

2024年表现最好的19只生物技术股

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 2024 年，生物技术行业出现了显著的复苏，克服了之前的挑战，为未来的增长奠定了基础。生物技术领域的风险投资资金从 2023 年的 212 亿美元增加到 281 亿美元，表明投资者信心重燃。2024 年也是首次公开募股（IPO）较好的一年，由风险投资支持的私营生物技术公司的并购（M&A）大幅上升。据外媒报道，以下生物技术公司成功地在股票表现方面脱颖而出。 2024 年，几家生物技术公司的股票表现斐然，尤其是 Bright Minds Biosciences、Monopar Therapeutics 和 Summit Therapeutics。 Bright Minds Biosciences：迷幻疗法的先驱 Bright Minds Biosciences专注于开发受致幻剂启发的下一代疗法。该公司的目标是创造一种既能保留致幻剂治疗效果，又能最大限度地减少其精神活性副作用的治疗方法。Bright Minds专门研究精确设计的5 -羟色胺能药物，靶向中枢神经系统（CNS）的特定受体亚型，以治疗一系列神经和精神疾病。 Bright Minds技术的核心是对5-羟色胺受体家族的研究，特别是5-HT2C受体。该公司的主要候选药物BMB-101是一种5-HT2C受体超激动剂，旨在解决难治性癫痫和某些神经精神疾病等疾病。选择性靶向这一受体亚型提供了一种有前景的治疗方法，因为它避免了激活与潜在心脏风险相关的5-HT2B受体和负责致幻作用的5-HT2A受体。该生物技术公司的股票表现在2024年飙升了惊人的1857%，主要受外部市场动态和其前景看好的产品线的推动。一个重大转折点是Lundbeck以26亿美元收购Longboard Pharmaceuticals，这激发了投资者的热情。Longboard的主要候选药物bexicaserin是一种5-HT2C受体超激动剂，这类药物与Bright Minds的BMB-101类似。此次收购引发了市场对5- ht2c靶向疗法日益增长的兴趣，提升了Bright Minds作为该领域领导者的地位。公司管线投资者可能认为这两家公司有相似之处，因为它们都专注于开发针对5-HT2C受体的疗法。此外，在2023年年中报告了BMB-101治疗癫痫的1期阳性结果后，Bright Minds于2024年启动了2期试验。该公司还在2024年底获得了3500万美元的私募。主流医学越来越接受迷幻疗法，这也是该股上涨的原因之一。迷幻药，曾经被污名化，现在作为一种合法的治疗方式，正在获得越来越多的关注，特别是在精神健康和神经疾病方面。 Monopar Therapeutics：在多个方面前进该公司的产品线包括旨在改善接受癌症治疗的患者和受罕见病影响的患者预后的治疗方法。 Monopar 以其主要候选药物 Validive（可乐定粘膜片剂）而闻名，这是一种正在开发的后期药物，用于减少接受头颈癌化疗的患者的严重口腔粘膜炎。然而，该公司于 2023 年 3 月宣布该药物未达到 2b/3 期的疗效阈值。 Monopar Therapeutics 的股价在 2024 年飙升了约 1,080%，这得益于两项重大发展，这些发展增强了投资者对公司战略和管线的信心。一个重要的里程碑是 Monopar 与 Alexion Pharmaceuticals 达成全球独家许可协议，开发 ALXN-1840，这是一种威尔逊病的后期候选药物，威尔逊病是一种罕见的遗传疾病，会导致铜在体内积累，导致严重的器官损伤。威尔逊病目前的治疗选择有限，而 ALXN-1840 代表了解决该病的重要选择。公司管线除了 ALXN-1840 许可协议外，Monopar 还宣布了 MNPR-101-Lu 的 1 期试验的首例患者给药，MNPR-101-Lu 是一种治疗侵袭性实体瘤的新型放射性药物。这是 Monopar 在 Validive 缓解结果后决定优先考虑的候选人。该化合物结合了 MNPR-101（一种选择性结合尿激酶纤溶酶原激活剂受体（uPAR）的人源化单克隆抗体）和放射性同位素镥-177 （Lu-177）。uPAR 是一种在各种侵袭性癌症中过表达的受体，包括胰腺癌、卵巢癌、三阴性乳腺癌和结直肠癌。这与该行业目前的放射性药物热潮是一致的。 Summit Therapeutics：推进双特异性抗体疗法 Summit Therapeutics 的主要项目以 ivonescimab 为中心，这是一种双特异性抗体，旨在通过结合免疫检查点抑制和抗血管生成两种关键作用机制来增强癌症治疗结果。 Ivonescimab 是一种双特异性抗体，可同时靶向 PD-1 （程序性死亡-1）和 VEGF （血管内皮生长因子）。PD-1 抑制剂，如默沙东的 Keytruda，通过阻断 PD-1 蛋白（使癌细胞逃避免疫检测）已成为免疫疗法的基石。另一方面，VEGF 促进肿瘤血管生成或新血管的形成，从而使癌症生长和扩散。通过靶向 PD-1 和 VEGF，ivonescimab 可增强免疫系统对肿瘤的活性，同时切断其血液供应。公司管线与传统的单靶点疗法相比，这种双重机制使 ivonescimab 具有显著优势，因为它解决了肿瘤存活和进展所涉及的两个关键过程。这种方法反映了肿瘤学的更广泛趋势，其中双特异性抗体因其通过同时处理多种途径来提高疗效的能力而受到关注。公司管线这家生物技术公司的股价在 2024 年大幅上涨了 576%，这主要是由于 ivonescimab 在临床试验中的成功。该公司在 2024 年世界肺癌大会上展示了数据，展示了 ivonescimab 在晚期非小细胞肺癌（NSCLC）患者中的卓越疗效。具体来说，该试验表明，与默克的 Keytruda 相比，无进展生存期（PFS）具有统计学意义的改善。此外，Summit 于 2024 年 9 月通过私募融资成功筹集了 2.35 亿美元。总体而言，股票表现的关键驱动因素当然是公司的成功——临床试验成功、监管批准或重大交易。这可能是哪些公司将成为 2025 年表现最好的公司的指标。参考资料： www.labiotech.eu -END- 2025CMC-CHINA药博会 • 展位火热预定中！

并购临床2期IPO

2025-01-15

·echemi

Johnson & Johnson Acquires Neuropharmaceutical Company for $14.6 Billion

On January 13, Johnson & Johnson announced that it has reached a final agreement with biopharmaceutical company Intra-Cellular Therapies, which focuses on the development and commercialization of drugs for central nervous system (CNS) diseases. Under the agreement, Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies at a price of $132 per share, totaling approximately $14.6 billion. The core asset of Intra-Cellular Therapies includes the orally administered antipsychotic product Caplyta (lumateperone). This drug is a 5-HT2A receptor antagonist and D2 dopamine receptor modulator, originally developed by Bristol-Myers Squibb (BMS) and licensed to Intra-Cellular Therapies for global development in 2015. In December 2019, Caplyta was approved by the FDA for the treatment of schizophrenia in adults. In December 2021, the drug was also approved for the adjunctive treatment of depressive episodes associated with bipolar I or II disorder. Furthermore, Intra-Cellular Therapies submitted a new indication application for Caplyta to the FDA in December 2024 for the adjunctive treatment of major depressive disorder (MDD) and is exploring its use in pediatric indications and long-acting formulations. Through this acquisition, Johnson & Johnson will also gain access to several pipeline candidates, including ITI-1284, lenrispodun, ITI-1020, ITI-333, and ITI-1549, further strengthening its pipeline in neuroscience. With the surge in mental health crises and the aging global population, over 1 billion people worldwide (or 1 in every 8 individuals) suffer from neuropsychiatric or neurodegenerative diseases. This substantial patient market has attracted numerous pharmaceutical companies. For instance, in December 2023, Bristol-Myers Squibb acquired Karuna Therapeutics for $14 billion, gaining the potential new schizophrenia drug Cobenfy (formerly KarXT), which was approved by the FDA in 2024. In the same month, AbbVie purchased Cerevel for $8.7 billion, obtaining several promising candidates for diseases such as schizophrenia, Parkinson's disease, and mood disorders. However, AbbVie's flagship project emraclidine failed to meet its expected endpoints in two Phase II studies targeting schizophrenia, reflecting the high-risk nature of new drug development in the neuroscience field. In October 2024, AbbVie acquired Aliada for $1.4 billion, securing its main project for Alzheimer's disease treatment ALIA-1758 to bolster its neuroscience pipeline. Similarly, in October 2024, Langbo Pharmaceuticals acquired Longboard Pharmaceuticals for $2.6 billion, obtaining a new epilepsy drug Bexicaserin. Johnson & Johnson's $14.6 billion acquisition of Intra-Cellular Therapies will undoubtedly inject new vitality into the neuroscience field. In 2024, there was only one merger in the pharmaceutical industry exceeding $10 billion, but at the start of 2025, Johnson & Johnson has made the first significant acquisition. With the JPM conference underway, more merger transactions are expected to occur in the pharmaceutical industry in the coming days.

上市批准细胞疗法并购临床2期免疫疗法

2025-01-14

·药智网

2025年药企巨额并购第一单

1月13日，强生宣布已与Intra-Cellular Therapies达成最终协议，将以每股132美元的价格收购后者的所有流通股份，总交易额约为146亿美元。 Intra-Cellular Therapies是一家专注于中枢神经系统（CNS）疾病治疗药物开发和商业化的生物制药公司。其核心资产是一款每日1次口服抗精神病产品Caplyta（lumateperone，芦玛哌酮）。该药物是一款5-羟色胺2A（5-HT2A）受体拮抗剂和多巴胺受体D2调节剂，由百时美施贵宝（BMS）首先研制，2015年Intra-Cellular Therapie获得BMS公司许可，进行全球开发。 2019年12月，Caplyta被FDA批准用于治疗精神分裂症成人患者，2021年12月又获批用于辅助治疗与I型或Ⅱ型双相情感障碍（双相抑郁症）相关的抑郁发作。2024年12月，Intra-Cellular还向FDA提交了Caplyta的第3项新适应症上市申请，用于重度抑郁症（MDD）的辅助治疗。此外，Intra-Cellular还在探索其儿童适应症和长效方案。除此之外，强生还获得ITI-1284、lenrispodun、ITI-1020、ITI-333、ITI-1549等多个在研管线，进一步加强了其神经领域的管线布局。图片来源：Intra-Cellular官网随着心理健康危机的激增和全球人口老龄化，全球有超过10亿人（即每8人中就有1人）患有神经精神疾病或神经退行性疾病。潜力巨大的患者市场吸引力众多药企布局： 2023年12月，百时美施贵宝以140亿美元收购Karuna，获得精神分裂症潜力新药Cobenfy（曾用名KarXT），该药已于2024年获得FDA批准上市。 2023年12月，艾伯维以87亿美元的价格收购Cerevel公司，获得多个具有治疗精神分裂症、帕金森病以及情绪障碍等多种疾病的潜力候选药物。不过，随后其“王牌项目”emraclidine未能在两项针对精神分裂症的Ⅱ期研究中达到预期终点，体现了神经领域新药开发的高风险性。 2024年10月，艾伯维又以14亿美元收购Aliada，获得其主要项目阿尔茨海默病（AD）疗法ALIA-1758强化神经科学管线。 2024年10月，灵北制药以26亿美元价格收购Longboard Pharmaceuticals，获得癫痫新药Bexicaserin。本次强生146亿美元收购Intra-Cellular，将为神经科学领域再添一把火。小结：2024年制药行业仅一笔超过百亿美元的并购，而2025年开年强生就打响了超百亿美元巨额并购第一枪。JPM大会也才刚刚开始，未来几天制药行业有望产生更多并购交易。参考来源： https://www.jnj.com/media-center/press-releases/johnson-johnson-strengthens-neuroscience-leadership-with-acquisition-of-intra-cellular-therapies-inc 友情推荐：医药行业深度技术内容，点击“博药”查看详情~ 声明：本内容仅用作医药行业信息传播，不代表药智网立场。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石合作、投稿 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

并购免疫疗法上市批准临床2期

100 项与 Bexicaserin 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
癫痫发作	临床3期	美国	Longboard Pharmaceuticals, Inc.	2024-10-02
癫痫发作	临床3期	中国	Longboard Pharmaceuticals, Inc.	2024-10-02
癫痫发作	临床3期	澳大利亚	Longboard Pharmaceuticals, Inc.	2024-10-02
癫痫发作	临床3期	比利时	Longboard Pharmaceuticals, Inc.	2024-10-02
癫痫发作	临床3期	巴西	Longboard Pharmaceuticals, Inc.	2024-10-02
癫痫发作	临床3期	加拿大	Longboard Pharmaceuticals, Inc.	2024-10-02
癫痫发作	临床3期	法国	Longboard Pharmaceuticals, Inc.	2024-10-02
癫痫发作	临床3期	德国	Longboard Pharmaceuticals, Inc.	2024-10-02
癫痫发作	临床3期	意大利	Longboard Pharmaceuticals, Inc.	2024-10-02
癫痫发作	临床3期	拉脱维亚	Longboard Pharmaceuticals, Inc.	2024-10-02

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适应症

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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


NCT05364021 (PACIFIC, NEWS) 人工标引	N/A	癫痫发作	40	Bexicaserin	鑰艱廠廠製襯構製構築(齋鬱壓顧鑰醖範簾遞鑰) = 簾獵廠顧選艱繭築憲獵鹹衊艱膚蓋遞鑰鹹餘鬱 (繭窪夢餘膚遞構鹽鏇窪 ) 更多	积极	2024-06-17
NCT05364021 (PACIFIC, Corporate Publications) 人工标引	临床1/2期	婴儿癫痫性运动障碍性脑病	52	LP352	糧製蓋願鹽淵繭築憲簾(醖廠餘築製構鹹鏇膚範) = 夢壓構構艱顧鏇鏇構鑰壓獵觸顧築構廠淵範願 (憲餘觸範鏇淵獵襯築衊 ) 更多	积极	2024-01-02
				Placebo	糧製蓋願鹽淵繭築憲簾(醖廠餘築製構鹹鏇膚範) = 製餘衊築壓齋觸繭遞衊壓獵觸顧築構廠淵範願 (憲餘觸範鏇淵獵襯築衊 )
IEC2023	N/A	-	-	LP352 6 mg TID	鑰糧構醖積壓醖夢構衊(鏇夢齋鹹獵範築顧窪糧) = 獵衊築襯網糧鏇淵鹽鹹選衊鹽襯鹽餘遞鏇顧範 (膚衊鹽顧鬱鹽鹹繭鹽蓋 ) 更多	-	2023-09-04
				LP352 12 mg TID	鑰糧構醖積壓醖夢構衊(鏇夢齋鹹獵範築顧窪糧) = 構觸蓋廠製蓋顧鹽鹹蓋選衊鹽襯鹽餘遞鏇顧範 (膚衊鹽顧鬱鹽鹹繭鹽蓋 ) 更多
102 (Corporate Publications) 人工标引	临床1期	癫痫性脑病	20	LP-352 (Cohort 1 = 6 mg)	網鏇繭廠製構鹹壓鏇淵(餘衊憲衊構窪繭製夢壓) = Favorable safety and tolerability results were observed in this study, with adverse events (AEs) generally consistent with previous clinical studies 繭壓醖齋觸憲蓋膚齋觸 (選鹹獵膚觸衊醖糧遞構 )	积极	2022-12-05
				LP-352 (Cohort 2 = 12 mg)
AAN2022	N/A	-	-	LP352	餘構簾範鏇鑰顧壓鏇蓋(鏇鹹衊鏇壓淵製鑰鏇鹹) = mild to moderate in severity 積顧遞鹹齋顧積獵糧憲 (鏇顧醖窪餘醖餘願觸願 ) 更多	积极	2022-05-03