A Randomised, Double-blind, Placebo-controlled, Phase 1 First-in-human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single- and Multiple-ascending Doses of BEN8744 in Healthy Subjects.

BEN8744 is an experimental new medicine for treating inflammatory bowel diseases such as Ulcerative Colitis.
The study will test single and repeated doses of BEN8744 or placebo by mouth. BEN8744 is a first in human study, so will start with a small dose and the dose will be increased as the study progresses. The goal is to find out its side effects and blood levels when taken by mouth and whether food affects the blood levels.
This is a 3-part study (Parts A, B and C) in up to 108 healthy people, aged 18-65.
Part A, will include up to 64 participants, single doses of BEN8744 or placebo. They'll take about 2 weeks to finish the study, stay on the ward for 4 nights and 5 days in a row and make 2 outpatient visits.
Part B, will include up to 12 participants, single doses of BEN8744 with and without food. They'll take up to 3 weeks to finish the study, stay on the ward for 4 nights and 5 days in a row on 2 occasions, and make 2 outpatient visits.
Part C will include up to 32 participants repeat doses of the BEN8744 or placebo for 14 days. They'll take about 4 weeks to complete the study, stay on the ward for 17 nights and 18 days in a row and make 2 outpatient visits.

开始日期2023-08-30

申办/合作机构

BenevolentAI Bio Ltd.

100 项与 BEN-8744 相关的临床结果

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100 项与 BEN-8744 相关的转化医学

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100 项与 BEN-8744 相关的专利（医药）

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项与 BEN-8744 相关的新闻（医药）

2024-04-23

·FierceBiotech

BenevolentAI lays off 30% of staff, exits US site as funding gap looms

BenevolentAI said the changes will extend its cash runway into late in the third quarter of 2025. The cuts keep coming at BenevolentAI. Eleven months after restructuring, the AI-enabled drug developer is pulling another pivot, axing plans to launch software products, laying off another 30% of staff and closing its U.S. office. BenevolentAI last reset in May 2023, when it laid off up to 180 staff, reduced its lab footprint, paused some programs and dropped its lead candidate in the aftermath of the failure of a midphase eczema clinical trial. The biotech exited the restructuring focused on two business units: an AI software product group and a drug development wing. Tuesday, BenevolentAI shifted gears again. The group focused on software products, which the biotech calls “Knowledge Exploration Tools,” is bearing the brunt. Last month, BenevolentAI told investors it had completed initial product development and most user testing and was assessing the market. The assessment persuaded BenevolentAI to stop work on the software “given the investment needed to fully commercialize this [software-as-a-service] product and the estimated timeframe to see a potential meaningful financial return.” BenevolentAI sees its drug discovery collaborations and in-house pipeline as a better use of the money. As part of the changes, the biotech is laying off 30% of staff. BenevolentAI ended (PDF) last year with 248 employees, a figure that reflected the 30% headcount cut made in 2023. The figures suggest the latest layoffs will affect tens of people. BenevolentAI is funneling some of the cash saved through the actions into development of BEN-8744, a PDE10 inhibitor for ulcerative colitis. The biotech is preparing to take the candidate into phase 1b/2a trials. Factoring in extra investment in BEN-8744, BenevolentAI estimated the changes will reduce cash burn by around 20% and extend its cash runway into late in the third quarter of 2025. The runway is an improvement over the mid-2025 forecast BenevolentAI shared with investors in March but could still pose problems for the biotech. Investors have soured on the company, causing its share price to languish below 1 euro ($1) for much of 2024 and limiting its ability to raise money. BenevolentAI expects milestones to add to its cash in 2026 and beyond, but the runway stops short of those paydays. To bridge the gap, the biotech is aiming to enter into one or more collaborations and out-license at least one pipeline program this year. BenevolentAI is partnered with AstraZeneca, Eli Lilly and Merck KGaA. The company will retain “key skills, experience and capabilities” and maintain its ability to support new and existing collaborations after the latest layoffs.

2024-04-23

·Firstwordpharma

BenevolentAI to cut 30% of staff, shutter US office in latest reset

AI drug discovery firm BenevolentAI announced a new restructuring initiative Tuesday that will see it reduce its headcount by about 30% and close its US office while maintaining its two largest sites in London and Cambridge, UK. The cuts, which come under the direction of new CEO Joerg Moeller, will trim cash burn by around 20%, extending the company's runway into late in the third quarter of 2025.A portion of those savings will be reinvested into Phase Ib/IIa development of its oral PDE10 inhibitor BEN-8744, BenevolentAI's lead drug candidate for ulcerative colitis that recently delivered positive Phase Ia data.To bridge the funding gap to year-end 2025, when it expects to receive "further larger milestones" from existing partner programmes, BenevolentAI indicated that it plans to pursue new drug-discovery collaborations and also out-license at least one of its pipeline assets this year. The company currently has partnerships with AstraZeneca and Merck KGaA as well as Eli Lilly.BenevolentAI expects to have about 180 employees left by the end of this year, noting that "key skills, experience and capabilities have been retained."The latest moves follow a restructuring undertaken by BenevolentAI in May of last year when it laid off up to 180 employees, reduced its lab footprint and paused some programmes, while also discontinuing development of its topical pan-Trk inhibitor BEN-2293 after a Phase IIa atopic dermatitis trial was found to be inconclusive.Those actions, which were expected to extend cash runway into mid-2025, reorganised BenevolentAI into two core business units, one focused on drug R&D and the other a tech business unit offering a suite of AI products for biopharma partners. However, in its latest reset, the company has decided to shutter its software-as-a-service (SaaS) offering that it refers to as Knowledge Exploration Tools, citing "the investment needed to fully commercialise this SaaS product and the estimated timeframe to see a potential meaningful financial return."In the company's release Tuesday, Moeller said "focusing our organisation on furthering our drug discovery collaborations and progressing our proprietary pipeline is the best way to achieve both the goal, of delivering value creation for our shareholders and delivering innovative medicines."

临床1期临床2期临床结果

2024-03-31

·药明康德

4周体重下降近10斤的小分子减肥药物；疾病发作率降低超90%的单抗… | 一周盘点

▎药明康德内容团队编辑本期看点1. 小分子口服疗法VK2735在治疗肥胖症的1期临床试验中获得了积极结果，接受最高剂量治疗的受试者在28天后体重减少5.3%。2. 用于治疗Dravet综合征的反义寡核苷酸（ASO）疗法STK-001在早期临床试验中的疗效亮眼，用药后3个月时，患者的癫痫发作频率降低了85%。3. 6个月内使用1-2次血浆激肽释放酶单克隆抗体抑制剂STAR-0215在早期临床试验中使遗传性血管性水肿（HAE）患者的每月发作率降低了90%-96%。药明康德内容团队整理VK2735：公布1期临床试验的新数据Viking Therapeutics公司于近期宣布，该公司的口服疗法VK2735在治疗肥胖症的1期临床试验中获得了积极结果。VK2735是胰高血糖素样肽1（GLP-1）和葡萄糖依赖性促胰岛素多肽（GIP）受体的双重激动剂，正在开发用于治疗肥胖等各种代谢性疾病。GIP和GLP-1是调控血糖的天然肠促胰岛素激素。这项为期28天的剂量递增研究结果突显了口服VK2735治疗的积极临床活性。接受VK2735治疗的患者队列显示出剂量依赖性体重减少，与基线相比最高达到5.3%（4.9公斤）。接受VK2735治疗的队列与安慰剂相比也显示平均体重减少，最高可达3.3%。基于这些1期试验结果，该公司计划在今年晚些时候，启动VK2735口服剂型治疗肥胖的2期临床试验。▲口服VK2735剂量依赖性降低受试者体重（图片来源：Viking Therapeutics公司官网）STK-001：公布1/2a期临床试验的新数据Stoke Therapeutics公司公布了其在研ASO疗法STK-001在两项1/2a期试验与两项开放标签扩展（OLE）试验中，治疗Dravet综合征儿童和青少年患者的积极数据。Dravet综合征通常与编码NaV1.1通道α亚基的SCN1A基因发生突变有关。人体中有两个SCN1A基因拷贝，如果其中一个拷贝因为产生突变而无法产生功能性蛋白，会导致NaV1.1蛋白水平下降。STK-001旨在通过与正常SCN1A基因拷贝生成的mRNA前体结合，促进更多能够表达蛋白的成熟mRNA的产生，从而恢复NaV1.1水平，减少癫痫发作和非癫痫合并症的发生。STK-001已被美国FDA和欧洲药品管理局（EMA）授予孤儿药资格，并被美国FDA授予罕见儿科疾病资格，用以治疗Dravet综合征。此次公布的结果显示，STK-001在给药后3个月可显著且持久地降低患者癫痫发作频率达85%，且药物的耐受性良好。此外，12个月时，患者的多种认知和行为测量结果均具有临床意义的改善，包括Vineland适应性行为量表（VINELAND-3）中的多个参数，这些结果支持STK-001具有改变疾病进展的潜力。Stoke公司将与监管机构讨论相关随机对照注册研究计划，以进一步推动STK-001的开发。根据新闻稿，这些数据支持STK-001成为首款具改变疾病进展能力的Dravet综合征药物。STAR-0215：公布1b/2期临床试验的初步数据Astria Therapeutics公司公布了其用于治疗遗传性血管性水肿的血浆激肽释放酶单抗抑制剂STAR-0215的1b/2期临床试验的初步数据。此前公布的1a期临床试验结果显示，STAR-0215具有作为长效血浆激肽释放酶抑制剂的潜力，半衰期长达117天，支持STAR-0215每三个月给药一次或以更低的频率给药。此次公布的结果显示，在6个月内给药1次或2次STAR-0215，可将HAE的每月发病率降低90%-96%，该结果支持每年仅给药2次或4次。此外，使用STAR-0215后，中度或严重HAE发作减少了92%-100%，需要使用急救药物的发作减少了91%-95%。安全性方面，STAR-0215的耐受性非常好，无严重不良事件，无停药现象。▲接受STAR-0215治疗的HAE患者的每月发病率（图片来源：参考资料[3]）ABBV-RGX-314：公布1/2a期临床试验的初步数据REGENXBIO公司公布了其一次性视网膜下注射的基因疗法ABBV-RGX-314用于治疗湿性年龄相关性黄斑变性（AMD）患者的早期安全性和耐受性数据。ABBV-RGX-314以该公司专有的NAV平台开发的腺相关病毒8（AAV8）作为载体，搭载旨在抑制血管内皮生长因子（VEGF）的抗体片段的基因编码。ABBV-RGX-314通过抑制VEGF通路从而抑制新的、渗漏的血管生长及其导致的视网膜积液。此次公布的结果表明，单次注射ABBV-RGX-314的耐受性普遍良好。两年后，大多数患者的视力和视网膜厚度保持稳定或有所改善，只需少量或无需补充注射抗VEGF疗法。REGENXBIO公司还报告了ABBV-RGX-314长期随访研究的其他积极中期数据，结果表明，该疗法的耐受性良好，并显示出长达四年的长期且持久的治疗效果。CAN-3110：公布1b期临床试验的新数据Candel Therapeutics公司公布了其用于治疗复发性高级别胶质瘤（rHGG）的候选溶瘤病毒疗法CAN-3110的1b期临床试验的新数据。CAN-3110是潜在“first-in-class”的单纯疱疹病毒-1（HSV-1）溶瘤免疫疗法，具有溶瘤和免疫激活的双重活性。该疗法使用的病毒经过工程化设计，具有复制能力，其负责病毒复制的基因ICP34.5受Nestin特异性启动子的转录控制。Nestin在神经胶质瘤细胞和其他肿瘤组织中高表达，但不在健康成人的大脑中表达，故通过此设计可避免CAN-3110影响邻近的正常细胞。此前公布的数据显示，接受了单次瘤内注射CAN-3110治疗的rHGG患者的中位总生存期（OS）有所改善，为11.6个月，而此类患者的历史中位OS约为6-9个月。HSV-1血清学阳性是一种预测缓解的指标，并与生存率的提高有关，HSV-1血清学阳性患者的中位OS达到了14个月。此次公布的结果表明，在rHGG患者中重复注射CAN-3110是可行的，而且耐受性良好，未观察到剂量限制性毒性。此外，重复注射CAN-3110有望进一步提高这种在研药物的临床活性。SNK01：公布1期临床试验数据NKGen Biotech公司公布其在研自然杀伤（NK）细胞疗法SNK01用于治疗阿尔茨海默病（AD）的1期临床试验数据。SNK01是一款自体、非基因工程改造的NK细胞产品。它具有增强的细胞毒性和激活性受体的表达。此次公布的试验结果显示，SNK01除了先前披露的对淀粉样蛋白β（Aβ）和神经炎症生物标志物的积极影响外，对晚期阿尔茨海默病患者的认知功能也具有临床疗效。静脉输注的SNK01能够穿过血脑屏障，降低脑脊液（CSF）中的生物标志物水平，包括Aβ42/40、Tau蛋白和α-突触核蛋白。在10名可评估AD患者中，90%患者的ADCOMS评分较基线时有改善或保持稳定。50%患者CSF中的pTau217降低；80%患者的CSF pTau181较基线时稳定/降低；30%患者的血浆pTau217降低；40%患者的血浆pTau181降低，这些效果一直延续到第22周。安全性方面，未观察到治疗相关不良事件。Annamycin：公布1b/2期临床试验数据Moleculin Biotech公司公布了其下一代蒽环类小分子疗法annamycin联用阿糖胞苷（AnnAraC）用于治疗复发/难治性急性髓系白血病（AML）患者的1b/2期临床试验的积极结果。在动物模型中，annamycin已被证明在肺部积累的含量为阿霉素的30倍，在多项早期人体临床试验中未显示出在蒽环类药物中常见的心脏毒性。此次公布的数据显示，AnnAraC治疗AML患者的复合完全缓解（CRc）率达到了60%，完全缓解（CR）率为50%。新闻稿指出，AnnAraC有望使接受二线治疗的AML患者的CR率比接受现有二线疗法的AML患者提高一倍以上。此外，在多项研究中，所有82名接受annamycin治疗的受试者在研究期间均未出现心脏毒性症状，毒性低于传统的强化疗法。BEN-8744：公布1a期临床试验数据BenevolentAI公司公布了其在健康受试者中开展的BEN-8744的1a期临床研究的积极安全性数据。BEN-8744是一种口服、外周限制性PDE10抑制剂，目前正被开发为中度至重度溃疡性结肠炎（UC）患者的潜在“first-in-class”治疗药物。PDE10是一种双重磷酸二酯酶，可降低细胞内信号分子cAMP和cGMP的水平。BEN-8744旨在抑制PDE10以恢复cAMP和cGMP的水平，有望通过改善屏障的完整性直接起到抗炎和潜在的疾病调节作用。该1a期研究达到了主要目标。BEN-8744的安全性和耐受性良好，任何剂量组均未报告严重不良事件（SAE）。药代动力学特征表明，每日两次给药BEN-8744能达到所需的PDE10靶点覆盖率，从而在UC患者的后续临床研究中产生潜在的治疗效果。该公司的新闻稿指出，以PDE10为靶点的BEN-8744与现有的标准治疗方法相比具有显著的差异化潜力。VRON-0200：公布1b期临床试验数据Virion Therapeutics公司公布了其新型、潜在“first-in-class”的检查点修饰免疫疗法VRON-0200用于功能性治愈慢性乙型肝炎病毒（HBV）感染患者的1b期临床试验的安全性数据。结果显示，前10名接受治疗的慢性HBV感染患者对VRON-0200的耐受性良好，没有报告重大不良事件，也没有报告实验室检查、心电图（ECG）或生命体征等方面的临床相关异常。大家都在看作为药明康德旗下专注于细胞和基因疗法的CTDMO，药明生基致力于加速和变革基因和细胞治疗及其他高端治疗的开发、测试、生产和商业化。药明生基能够助力全球客户将更多创新疗法早日推向市场，造福病患。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] BenevolentAI Announces Positive Topline Safety and Pharmacokinetic Data from the Phase Ia Clinical Study of BEN-8744 in Healthy Volunteers. 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Retrieved March 26, from https://www.prnewswire.com/news-releases/aptamer-sciences-inc-files-ind-application-for-innovative-liver-cancer-treatment-ast-201-a-promising-approach-to-address-under-medical-needs-302098802.html[5] NKGen Biotech Presents Additional Phase 1 Clinical Trial Data in Alzheimer’s Disease at the Tau2024 Global Conference. Retrieved March 26, from https://www.globenewswire.com/news-release/2024/03/25/2851989/0/en/NKGen-Biotech-Presents-Additional-Phase-1-Clinical-Trial-Data-in-Alzheimer-s-Disease-at-the-Tau2024-Global-Conference.html[6] Apogee Therapeutics Announces First Participants Dosed in Phase 1 Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) and Other Inflammatory Diseases. Retrieved March 26, from https://www.globenewswire.com/news-release/2024/03/25/2851495/0/en/Apogee-Therapeutics-Announces-First-Participants-Dosed-in-Phase-1-Trial-of-APG808-its-Novel-Half-life-Extended-IL-4R%CE%B1-Antibody-for-the-Treatment-of-Chronic-Obstructive-Pulmonary-Di.html[7] Rhythm Pharmaceuticals Announces First Patient Dosed in Phase 1 Trial Evaluating RM-718, a Weekly MC4R-specific Agonist. Retrieved March 26, from https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-first-patient-dosed-phase-1[8] Stoke Therapeutics Announces Landmark New Data That Support the Potential for STK-001 to be the First Disease-Modifying Medicine for the Treatment of Patients with Dravet Syndrome. Retrieved March 26, from https://www.businesswire.com/news/home/20240325745654/en[9] Tectonic Therapeutic Initiates Phase 1B Study for TX45 in Group 2 Pulmonary Hypertension in Patients with Preserved Ejection Fraction Heart Failure. Retrieved March 26, from https://www.businesswire.com/news/home/20240325487405/en[9] Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate. Retrieved March 26, from https://valneva.com/press-release/valneva-initiates-phase-1-trial-of-second-generation-zika-vaccine-candidate/[10] Opus Genetics Announces Completion of Dosing in First Cohort of Phase 1/2 Trial of Gene Therapy OPGx-LCA5 in Patients with Rare Inherited Retinal Disease LCA5. Retrieved March 26, from https://opusgtx.com/companynews/opus-genetics-announces-completion-of-dosing-in-first-cohort-of-phase-1-2-trial-of-gene-therapy-opgx-lca5-in-patients-with-rare-inherited-retinal-disease-lca5/[11] CinFina Pharma Announces FDA Clearance of Investigational New Drug Application and First Participants Dosed in Phase 1 Trial of CIN-110 for the Treatment of Obesity. Retrieved March 26, from https://www.businesswire.com/news/home/20240326703050/en[12] Viking Therapeutics Announces Results from Phase 1 Clinical Trial of Oral Tablet Formulation of Dual GLP-1/GIP Receptor Agonist VK2735. Retrieved March 26, 2024, from https://www.prnewswire.com/news-releases/viking-therapeutics-announces-results-from-phase-1-clinical-trial-of-oral-tablet-formulation-of-dual-glp-1gip-receptor-agonist-vk2735-302098869.html[13] Immuneering Announces First Patient Dosed in its Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations. Retrieved March 28, 2024, from https://ir.immuneering.com/news-releases/news-release-details/immuneering-announces-first-patient-dosed-its-phase-12a-trial[14] Iambic Therapeutics Announces First Patient Dosed in Phase 1 Clinical Study of IAM1363, a Highly Selective HER2 Inhibitor for the Treatment of Solid Tumors. Retrieved March 28, 2024, from https://www.businesswire.com/news/home/20240327705577/en[15] Sagimet Biosciences Announces Completion of Phase 1 Hepatic Impairment Study with FASN Inhibitor Denifanstat. Retrieved March 28, 2024, from https://ir.sagimet.com/news-releases/news-release-details/sagimet-biosciences-announces-completion-phase-1-hepatic[16] Promising First-In-Human Phase 1B Clinical Study Data from VRON-0200, a Novel, First-in-Class Checkpoint Modifier Immunotherapy for Chronic Hepatitis B Virus Functional Cure, Presented as Late-Breaker at 2024 APASL Global Liver Meeting. Retrieved March 28, 2024, from https://www.prnewswire.com/news-releases/promising-first-in-human-phase-1b-clinical-study-data-from-vron-0200-a-novel-first-in-class-checkpoint-modifier-immunotherapy-for-chronic-hepatitis-b-virus-functional-cure-presented-as-late-breaker-at-2024-apasl-global-liver-me-302100640.html[17] Candel Therapeutics Announces Oral Presentation During the 5th Glioblastoma Drug Development Summit with Update on Phase 1b Clinical Trial of CAN-3110 in Recurrent High-Grade Glioma. Retrieved March 28, 2024, from https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-announces-oral-presentation-during-5th[18] Nested Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for NST-628, a Novel Pan-RAF/MEK Molecular Glue. Retrieved March 28, 2024, from https://www.prnewswire.com/news-releases/nested-therapeutics-announces-fda-clearance-of-investigational-new-drug-ind-application-for-nst-628-a-novel-pan-rafmek-molecular-glue-302101827.html[19] REGENXBIO Announces Lancet Publication of Phase I/IIa Study Evaluating ABBV-RGX-314 as a One-Time Gene Therapy for Wet AMD. Retrieved March 28, 2024, from https://www.prnewswire.com/news-releases/regenxbio-announces-lancet-publication-of-phase-iiia-study-evaluating-abbv-rgx-314-as-a-one-time-gene-therapy-for-wet-amd-302102175.html[20] Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1065890, a Second-Generation VMAT2 Inhibitor, in Healthy Adults. Retrieved March 28, 2024, from https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-initiation-of-phase-1-clinical-study-evaluating-effects-of-nbi-1065890-a-second-generation-vmat2-inhibitor-in-healthy-adults-302101715.html[21] Aurion Biotech Announces First Canadian Subject Dosed in Phase 1 / 2 Clinical Trial. Retrieved March 28, 2024, from https://www.businesswire.com/news/home/20240328939779/en[22] MAPLIGHT THERAPEUTICS ANNOUNCES INITIATION OF PHASE 1 CLINICAL TRIAL FOR ML-007/PAC, UNDER DEVELOPMENT FOR SCHIZOPHRENIA AND ALZHEIMER'S DISEASE PSYCHOSIS. Retrieved March 28, 2024, from https://www.prnewswire.com/news-releases/maplight-therapeutics-announces-initiation-of-phase-1-clinical-trial-for-ml-007pac-under-development-for-schizophrenia-and-alzheimers-disease-psychosis-302102849.html免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

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