RANDOMIZED DOUBLE BLIND CONTROLLED STUDY ASSESSING THE EFFICACY OF FECAL MICROBIOTA TRANSPLANTATION IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS RESISTANT TO CONVENTIONAL TREATMENT

Current pharmacological management of inflammatory rheumatism and in particular axial SpA remains imperfect. Only 50% of patients respond to the most effective biotherapies, and many of them are only partially relieved. In addition, these are extremely expensive treatments that expose them to the risk of potentially serious side effects. Compelling evidence indicates that gut dybiosis could be a critical trigger of inflammation in axial SpA and thus correcting dysbiosis represents an attractive way of reversing the pathogenic process.The efficacy of FMT in patients with axial SpA has never been studied. This randomized double-blind study will be the first to assess feasability of FMT in axial SpA, the capacity of this procedure to restore healthy microbiome, its tolerance and its potential efficacy on disease activity. If sucessfull, this trial would set the path to larger-scale clinical trials of FMT to treat axial SpA.
Two-co primary objectives in a hierarchical design:
to evaluate the capacity of FMT to correct dysbiosis in active axial SpA despite well-conducted phamacological treatment by replacing pre-existing dysbiotic microbiota with healthier microbiota.
to explore the efficacy of FMT versus placebo on clinical evolution of SpA.

开始日期2024-03-28

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT05762211 / Recruiting临床2期

A Multi-center Randomized, Double Blinded Phase IIb Trial Evaluating Oral Pooled Fecal Microbiotherapy MaaT033 to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

This randomized, placebo-controlled phase IIb study (PHOEBUS trial) aims to evaluate the activity of fecal microbiotherapy MaaT033 to improve survival through the prevention of transplant-related complications in eligible alloHCT patients

开始日期2023-10-31

申办/合作机构

Maat Pharma SA

CTIS2022-501831-18-00 / Recruiting

A multi-center randomized, double blinded phase IIb trial evaluating oral pooled fecal microbiotherapy MaaT033 to prevent allogeneic hematopoietic cell transplantation complications - MPOH08

开始日期2023-10-18

申办/合作机构

Maat Pharma SA

100 项与 MaaT-033 相关的临床结果

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100 项与 MaaT-033 相关的转化医学

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100 项与 MaaT-033 相关的专利（医药）

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项与 MaaT-033 相关的新闻（医药）

2024-12-01

·药明康德

完全缓解率达75%的T细胞激活剂；使帕金森病患者步态冻结症状完全消失的细胞疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. γ9δ2 T细胞激活剂ICT01联用阿扎胞苷和维奈托克治疗新确诊的老年和/或不适合标准治疗的急性髓系白血病（AML）患者，总完全缓解（CR）率达75%。 2. 治疗实体瘤软脑膜转移（LM）的放射治疗药物Rhenium（186Re）obisbemeda与标准的外照射放疗相比，可使中枢神经系统（CNS）蛛网膜下腔吸收的辐射剂量提高多达8倍。 3. 细胞疗法TED-A9在治疗帕金森病的1/2a期临床试验中表现亮眼，高剂量组所有3名患者的步态冻结症状完全消失。药明康德内容团队整理 ICT01：公布1/2a期临床试验数据 ImCheck Therapeutics公司公布了其新型γ9δ2 T细胞激活剂ICT01联用阿扎胞苷和维奈托克治疗新确诊的老年和/或不适合标准治疗的AML患者的积极1/2a期临床试验数据。γ9δ2 T细胞是先天免疫系统的一部分，负责对肿瘤和感染的免疫监察。ICT01是一款靶向嗜乳脂蛋白家族成员BTN3A的单克隆抗体疗法，通过与BTN3A结合，它可以选择性地激活γ9δ2 T细胞，并且促进它们迁移和浸润肿瘤，进一步激发CD8阳性T细胞和自然杀伤细胞的抗肿瘤反应。截至2024年7月19日的数据，16名疗效可评估患者的中位随访时间为4.0个月（范围0.7-7.4个月），总CR率为75%，CR/伴有血液学不完全恢复的完全缓解（CRi）率为94%。第1、2、3和4个治疗周期结束时达到CR/CRi的患者比例分别为44%、81%、88%和94%。总体而言，缓解持续时间为2.5个月，截至数据截止日期患者仍然在持续缓解。中位总生存期数据尚未成熟。 Rhenium（186Re）obisbemeda：公布1期临床试验的中期数据 Plus Therapeutics公司公布了其主打放射治疗药物Rhenium（186Re）obisbemeda治疗实体瘤软脑膜转移的临床试验ReSPECT-LM的最新数据。该疗法是一款新型可注射放疗药物，专门配制用于以安全、有效和方便的方式在CNS肿瘤中递送专一靶向的高剂量辐射，以优化患者临床结局。由于186Re的半衰期短，具有破坏癌组织的β放射能和可用于活体成像的γ放射能，是CNS治疗应用的理想放射性同位素。 20名患者接受了治疗，包括9名原发癌症为乳腺癌的患者，5名原发癌症为非小细胞肺癌的患者，以及6名原发癌症为其他癌症的患者。此次公布的结果显示，治疗后112天时，93%（14/15）患者的脑脊液循环肿瘤细胞（CTC）显示有缓解，包括1例CR和1例疾病稳定（SD）。磁共振成像（MRI）结果显示，75%（12/16）的患者获得缓解或SD，包括5例缓解和7例SD。临床应答结果显示，86%（12/14）的患者获得缓解或SD，包括2例部分缓解（PR）和10例SD。队列1-4组患者的中位总生存期为9个月，16名患者中有6人在分析时仍存活。此外，有3名患者在“同情使用”项目下接受了3次给药，这3名患者的生存时间均超过400天，其中1名患者甚至超过了30个月。新闻稿还指出，与标准的外照射放疗相比，该治疗方法可使CNS蛛网膜下腔吸收的辐射剂量提高多达8倍。 TED-A9：公布1/2a期临床的新试验数据 S.BIOMEDICS公司宣布了其细胞疗法TED-A9在治疗帕金森病的1/2a期临床试验中的首批6名受试者的1年随访数据。TED-A9是一款通过对人类胚胎干细胞（hESC）进行小分子化合物处理而生成的高度纯化中脑多巴胺能祖细胞。通过外科手术，hESC衍生的多巴胺能祖细胞被移植到患者双侧壳核的前、中、后部。移植后，这些细胞将成熟为多巴胺能神经元，通过增强帕金森病患者的神经连接，有望恢复患者的运动功能。此次公布的结果显示，根据Hoehn和Yahr量表，低剂量组（n=3）患者的运动症状平均改善了19.4%，而高剂量组（n=3）改善了44.4%，表明疾病状态从严重转向较轻。步态冻结（帕金森病患者常见的运动症状之一）在低剂量组的部分患者（1/2）中完全消失，在高剂量组的所有患者（3/3）中完全消失。神经影像技术结果显示，由移植细胞形成的突触中多巴胺转运蛋白（DAT）增加，高剂量组更为明显。安全性方面，没有观察到与移植细胞相关的问题。 INB-200：公布1期临床试验的新数据 IN8bio公司公布其耐化疗的转基因自体γδ T细胞疗法INB-200加入到胶质母细胞瘤患者的替莫唑胺（TMZ）维持治疗中的1期临床试验数据。INB-200是一种强大的协同治疗方法，能在患者接受化疗时持续存在，并保持其识别和杀死癌细胞的能力。此次公布的结果显示，92%接受INB-200协同治疗的可评估患者的无进展生存期（PFS）超过了接受标准治疗（Stupp方案）患者的中位PFS（6.9个月），大多数患者的PFS超过了基于年龄和肿瘤MGMT状态预测的PFS。此外，5名患者仍然存活，3名患者已返回工作岗位，其中1名患者在治疗后40.5个月时疾病仍然没有进展。活检结果显示，两名患者在接受INB-200治疗后，脑肿瘤微环境中持续存在着γδ T细胞以及CD3阳性和CD8阳性T细胞。安全性方面，任何队列中均未报告与治疗相关的严重不良事件、剂量限制性毒性（DLT）、细胞因子释放综合征（CRS）、输注反应或免疫效应细胞相关神经毒性（ICAN）。最常见的治疗相关不良事件是1-2级毒性，包括与标准护理TMZ相关的白细胞和血小板计数下降。 SCG101：公布1期临床试验数据星汉德生物（SCG Cell Therapy）公布了其自主研发的乙型肝炎病毒（HBV）特异性T细胞受体（TCR）-T细胞疗法SCG101的1期临床试验的新数据。SCG101是一种靶向乙型肝炎病毒表面抗原（HBsAg）的特异性自体TCR-T细胞疗法。星汉德生物依托自主研发的独有GianT技术平台，筛选高亲力且高活性的天然TCR，可以有效靶向实体肿瘤中通过主要组织相容性复合体（MHC）表达的细胞内抗原。临床前和临床研究数据显示，SCG101具有肿瘤抑制和HBV共价闭合环状DNA（cccDNA）根除作用，可实现抗肿瘤和抗病毒功能。此次公布的结果显示，SCG101在晚期HBV相关肝细胞癌（HCC）患者中显示出有希望的抗病毒活性。在接受单次静脉注射5.0×10^7-1.0×10^8个TCR-T细胞/kg剂量的SCG101治疗的12名患者中，所有患者的血清HBsAg水平均显著下降，其中11名患者（92%）的HBsAg水平下降了1.0-4.6 log10，并且在整个长达一年的随访期间，这些患者的HBsAg水平保持在100 IU/mL以下。值得注意的是，有4名患者（33%）在接受单次SCG101输注后的21天内实现了HBsAg的消失，并且这种状态持续了一整个随访期。SCG101的安全性总体上良好，治疗耐受性良好。最常见的治疗相关不良事件包括暂时性的肝酶升高、发热、细胞减少症、CRS、低白蛋白血症和低钠血症。 HL192（ATH-399A）：公布1期临床试验数据 HanAll Biopharma公司、Daewoong Pharmaceutical公司和NurrOn Pharmaceuticals公司成功完成了HL192（ATH-399A）的1期研究。HL192（ATH-399A）是一种用于治疗帕金森病的Nurr1激活剂，此前已在健康受试者中完成了一项1期研究。此次公布的结果显示，该研究在5个不同的剂量组中达到了安全性和耐受性的主要终点，表明在治疗这种使人衰弱的神经系统疾病方面迈出了有意义的一步。HL192（ATH-399A）的耐受性良好，76名受试者均无重大安全问题。接受治疗的患者与接受安慰剂的患者在治疗伴发不良事件上的发生率相当，没有明确的剂量依赖性趋势。药代动力学结果支持每天一次的给药方案。 MaaT033：公布1b期临床试验数据 MaaT Pharma公司宣布，其评估MaaT033在肌萎缩侧索硬化（ALS）患者中疗效的1b期临床试验IASO已达到主要终点。ALS患者连续服用MaaT033两个月后显示出良好的安全性和耐受性。初步的微生物组分析证实了MaaT033已成功移植，进一步支持了其安全性和耐受性结果。 MaaT033是一种源自供体、高浓度、高多样性的口腔微生物群生态系统疗法（Microbiome Ecosystem Therapy），目前正作为一种辅助疗法进行开发，以提高接受造血干细胞移植（HSCT）和其他细胞疗法的患者的总生存率。此前，MaaT033已被欧洲药品管理局（EMA）授予孤儿药资格。 ▲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] Immix Biopharma Presents Positive NXC-201 Clinical Data at 66th American Society of Hematology (ASH) Annual Meeting in 16 Relapsed/Refractory AL Amyloidosis Patients. Retrieved November 29, 2024, from https://immixbio.com/immix-biopharma-presents-positive-nxc-201-clinical-data-at-66th-american-society-of-hematology-ash-annual-meeting-in-16-relapsed-refractory-al-amyloidosis-patients/ [2] IN8bio Reports Continued Durable Remissions in Phase 1 Trial of INB-200 in Plenary Oral Presentation at the Society for Neuro-Oncology (SNO) Annual Meeting. Retrieved November 29, 2024, from https://investors.in8bio.com/news-releases/news-release-details/in8bio-reports-continued-durable-remissions-phase-1-trial-inb [3] S.BIOMEDICS Investigational Cell Therapy for Parkinson’s Disease With TED-A9 Shows Positive Data at 12-months in Phase 1/2a Clinical Trial. Retrieved November 29, 2024, from https://www.businesswire.com/news/home/20241126606645/en/S.BIOMEDICS-Investigational-Cell-Therapy-for-Parkinson%E2%80%99s-Disease-With-TED-A9-Shows-Positive-Data-at-12-months-in-Phase-12a-Clinical-Trial [4] SCG Cell Therapy Presents Promising Phase 1 Data for a Novel HBV-Specific TCR-T Therapy (SCG101) at the AASLD Liver Meeting 2024. Retrieved November 29, 2024, from https://www.prnewswire.com/news-releases/scg-cell-therapy-presents-promising-phase-1-data-for-a-novel-hbv-specific-tcr-t-therapy-scg101-at-the-aasld-liver-meeting-2024-302314896.html [5] Plus Therapeutics Presents Positive ReSPECT-LM Phase 1 Interim Data for Leptomeningeal Metastases at the 2024 SNO Annual Conference. Retrieved November 29, 2024, from https://www.globenewswire.com/news-release/2024/11/25/2986577/0/en/Plus-Therapeutics-Presents-Positive-ReSPECT-LM-Phase-1-Interim-Data-for-Leptomeningeal-Metastases-at-the-2024-SNO-Annual-Conference.html [6] 2876 ICT01, an Investigational γ9δ2 T Cell Activator, Added to Azacitidine-Venetoclax Achieves Frequent and Early Complete Remissions in Adults with AML Unfit for Intensive Induction Chemotherapy: Interim Results from the Ongoing Open-Label, Randomized Phase 1 Study Eviction. Retrieved November 29, 2024, from https://ash.confex.com/ash/2024/webprogram/Paper193493.html [7] HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals Announce Successful Completion of a First-in-Human Study for Potential Disease-Modifying Therapy for Parkinson's Disease. Retrieved November 29, 2024, from https://www.prnewswire.com/news-releases/hanall-biopharma-daewoong-pharmaceutical-and-nurron-pharmaceuticals-announce-successful-completion-of-a-first-in-human-study-for-potential-disease-modifying-therapy-for-parkinsons-disease-302315158.html [8] MaaT Pharma Announces Positive Phase 1b Results, Meeting Primary Endpoint in the Evaluation of MaaT033 in Amyotrophic Lateral Sclerosis (ALS). Retrieved November 29, 2024, from https://www.businesswire.com/news/home/20241125058999/en/MaaT-Pharma-Announces-Positive-Phase-1b-Results-Meeting-Primary-Endpoint-in-the-Evaluation-of-MaaT033-in-Amyotrophic-Lateral-Sclerosis-ALS/ [9] Hemogenyx Pharmaceuticals PLC Announces IRB Approval for Phase I Clinical Trial. Retrieved November 29, 2024, from https://www.accesswire.com/945940/hemogenyx-pharmaceuticals-plc-announces-irb-approval-for-phase-i-clinical-trial [10] GC Biopharma and Novel Pharma First Patient Dosed in Global Phase I Clinical Trial for MPS IIIA Treatment. Retrieved November 29, 2024, from https://www.prnewswire.com/news-releases/gc-biopharma-and-novel-pharma-first-patient-dosed-in-global-phase-i-clinical-trial-for-mps-iiia-treatment-302315952.html [11] Avirmax Biopharma Announces First Patient Dosed in Clinical Trial of ABI-110, a Groundbreaking Gene Therapy for Wet AMD Including PCV. Retrieved November 29, 2024, from https://www.prnewswire.com/news-releases/avirmax-biopharma-announces-first-patient-dosed-in-clinical-trial-of-abi-110-a-groundbreaking-gene-therapy-for-wet-amd-including-pcv-302313714.html [12] uniQure Announces Dosing of First Patient in GenTLE Phase I/IIa Clinical Trial of AMT-260 for the Treatment of Refractory Mesial Temporal Lobe Epilepsy. Retrieved November 29, 2024, from https://www.globenewswire.com/news-release/2024/11/21/2985098/0/en/uniQure-Announces-Dosing-of-First-Patient-in-GenTLE-Phase-I-IIa-Clinical-Trial-of-AMT-260-for-the-Treatment-of-Refractory-Mesial-Temporal-Lobe-Epilepsy.html [13] Tenaya Therapeutics Doses First Patient in RIDGE™-1 Phase 1b Clinical Trial of TN-401 for the Treatment of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy. Retrieved November 29, 2024, from https://investors.tenayatherapeutics.com/news-releases/news-release-details/tenaya-therapeutics-doses-first-patient-ridgetm-1-phase-1b [14] Hemogenyx Pharmaceuticals PLC Announces IRB Approval for Phase I Clinical Trial. Retrieved November 29, 2024, from https://www.accesswire.com/945940/hemogenyx-pharmaceuticals-plc-announces-irb-approval-for-phase-i-clinical-trial 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

放射疗法临床结果细胞疗法

2024-11-28

·PipelineReview

MaaT Pharma Announces Positive Phase 1b Results, Meeting Primary Endpoint in the Evaluation of MaaT033 in Amyotrophic Lateral Sclerosis (ALS)

LYON, France I November 26, 2024 I MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation,announced that the exploratory single-arm, open-label Phase 1b clinical trial named IASO ( NCT05889572 ) evaluating MaaT033 in ALS has met its primary endpoint assessing the safety and tolerability of MaaT033 with multiple doses. The independent Data Safety and Monitoring Board (DSMB) concluded that MaaT033 showed good safety and tolerability in ALS patients when dosed for two months. Preliminary microbiome analysis confirms the successful engraftment of MaaT033, the Company’s oral capsule, outlining further the safety and tolerability outcome. Prof. Gaëlle Bruneteau, Professor of Neurology at Sorbonne University and consultant neurologist at the Paris ALS expert center of the Pitié-Salpêtrière Hospital, Paris, France stated “I am encouraged by these Phase 1b results, which underscore the strong safety and tolerability profile of MaaT033 in ALS. Preclinical and clinical evidence suggests a role of the gut microbiota in the pathogenesis and variability of ALS and further studies are essential to fully explore the potential of the gut-brain axis in this disease.” Additional study endpoints are expected to be analysed in the coming months. Based on the current evidence from the Phase 1b IASO study, the DSMB supports proceeding to Phase 2. MaaT Pharma plans to determine the next steps based on a comprehensive analysis of the study’s overall data, expected in early 2025. These steps may include initiating a larger randomized controlled efficacy study, subject to appropriate funding options. Hervé Affagard, CEO and co-founder of MaaT Pharma shared “I want to express my full gratitude to the patients participating in this study while battling a devastating disease. The ALS trial represents a potentially transformative milestone in our mission to improve patient survival through innovative microbiome-based immune modulation therapies. These results demonstrate the potential versatility of our platform to address critical unmet medical needs across multiple therapeutic areas. As we look toward expanding the reach and impact of this innovation, we will explore collaboration opportunities to accelerate and broaden its application to benefit even more patients in need.” A total of 15 participants across two centers in France have been enrolled in the Phase 1 trial. This Study has been a collaborative effort involving leading researchers, clinicians from Hôpital de la Pitié-Salpêtrière – AP-HP and University Hospital of Lille, experts from the French academic FILSLAN/ ACT4ALS-MND and the French patients’ association Tous en Selles contre la SLA . These results, along with previous data from the Phase 1b CIMON trial in Acute Myeloid Leukemia and the latest DSMB for the ongoing Phase 2b trial PHOEBUS in Europe, bolster confidence in MaaT033’s safety profile in continued use. Key safety and tolerability data will be presented in a poster at the 35 th International symposium on ALS/ MND taking place in December 6-8, 2024, in Montreal, Canada. About MaaT Pharma MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. About MaaT033 MaaT033, a donor-derived, high-richness, high-diversity oral Microbiome Ecosystem Therapy TM containing anti-inflammatory Butycore TM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. MaaT033 is developed with the “pooling” technology, which allows pooling donations from multiple donors to create a standardized product with high microbial richness and diversity. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA). About Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease in the US and Charcot’s disease in Europe, is a progressive neurodegenerative disorder affecting motor neurons in the brain and spinal cord. This leads to muscle weakness, loss of voluntary movement, and eventually, paralysis and on an average lead to death in 3 to 5 years. ALS could affect up to 60,000 patients in US and EU by 2040 and hascurrently no curative treatment and few symptomatic treatments. SOURCE: MaaT Pharma

临床1期临床结果临床2期孤儿药免疫疗法

2024-11-26

·Endpoints

Aviceda aims to raise $200M; Nerviano gets back rights to PARP1 inhibitor

Plus, news about Maat Pharma, Secretome Therapeutics, 35Pharma, Medigene and Doron Therapeutics: Aviceda Therapeutics’ $200M financing: The Boston-area biotech is looking to raise a $200 million equity round, according to an SEC filing on Friday. The company recently completed enrollment for a Phase 2b study testing its investigational drug, called AVD-104, against Astellas’ Izervay in patients with geographic atrophy secondary to age-related macular degeneration. — Kyle LaHucik Nerviano’s dealmaking: Nerviano Medical Sciences will reacquire the worldwide rights to a PARP1 inhibitor dubbed NMS-293 from Merck KGaA. The drug is in a Phase 2 study in relapsed glioblastoma. The Italian biotech had received $65 million in upfront and option fees, the companies disclosed in September 2022. Earlier this month, NMS also bought a Phase 2-ready PARP7 inhibitor from Ribon Therapeutics ., which has shuttered. Terms of both deals were undisclosed. — Kyle LaHucik MaaT Pharma touts positive Phase 1b data for its ALS drug: The topline data shared Tuesday showed that the trial met its primary endpoint, assessing the safety and tolerability of the drug, dubbed MaaT033, with multiple doses in ALS patients over two months. More data are expected early next year. According to the company, the data safety and monitoring board for the trial supported moving the drug into a Phase 2 study. — Katherine Lewin Secretome Therapeutics raises $20.4M for heart therapies: The cell therapy company plans to use the proceeds to launch two Phase 1 trials for its lead asset, STM-01, in heart failure with preserved ejection fraction and dilated cardiomyopathy. The studies are expected to start by the end of the year. — Ayisha Sharma 35Pharma’s $35M Series C: Frazier Life Sciences led the financing round for the clinical-stage biopharma, which wants to use the money to support clinical proof-of-concept studies for its candidate in pulmonary hypertension and get its asset through a Phase 1 trial in HFpEF and obesity. — Katherine Lewin Medigene to lay off approximately 40% of its workforce: Along with the layoffs, the company is refocusing its capital on R&D programs with the “highest potential for return on invested capital.” As of Dec. 31, 2023, the company had 86 employees. — Katherine Lewin Doron Therapeutics bags $11M in Series A: The company said the funds will support the Chapel Hill, NC-based biotech as it advances its regenerative medicine candidate, Motys, into Phase 3 development for symptomatic knee osteoarthritis. The asset could offer “potent and durable effects from a single injection” as an alternative to surgical interventions, according to Doron. — Ayisha Sharma

临床2期临床1期细胞疗法临床3期

100 项与 MaaT-033 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
中轴性脊柱关节炎	临床3期	法国	Assistance Publique des Hôpitaux de Paris SA	2024-03-28
造血干细胞移植	临床2期	比利时	Maat Pharma SA	2023-10-31
造血干细胞移植	临床2期	法国	Maat Pharma SA	2023-10-31
造血干细胞移植	临床2期	德国	Maat Pharma SA	2023-10-31
造血干细胞移植	临床2期	荷兰	Maat Pharma SA	2023-10-31
造血干细胞移植	临床2期	西班牙	Maat Pharma SA	2023-10-31
造血干细胞移植	临床2期	英国	Maat Pharma SA	2023-10-31
移植并发症	临床2期	比利时	Maat Pharma SA	2023-10-31
移植并发症	临床2期	法国	Maat Pharma SA	2023-10-31
移植并发症	临床2期	德国	Maat Pharma SA	2023-10-31

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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


NCT05889572 (IASO, Company_Website) 人工标引	临床1期	肌萎缩侧索硬化	15	MaaT033	製衊鏇網衊襯艱襯範製(憲築餘遞獵製範餘淵淵) = MaaT033 showed good safety and tolerability in ALS patients when dosed for two months. 獵淵獵繭積鏇獵網鹹構 (網遞簾膚積選構繭襯夢 ) 达到	积极	2024-11-26
NCT05762211 (PHOEBUS, Biospace) 人工标引	临床2期	造血干细胞移植	20	MaaT033	艱鹽憲夢構艱淵鑰願獵(積餘壓鑰淵選蓋願範餘) = The DSMB, composed of 5 independent experts, reviewed safety data on the first 20 patients (cutoff date as of April 30th, 2024) and concluded that safety was acceptable and well tolerated. 簾襯鹹鹹壓齋觸餘壓觸 (簾鑰夢鬱築觸夢鹹構蓋 )	积极	2024-07-03
NCT05889572 (IASO, BusinessWire) 人工标引	临床1期	肌萎缩侧索硬化	8	MaaT033	繭鏇廠壓餘鏇簾襯鬱製(製鬱構鬱齋獵構鏇繭觸) = MaaT033 has shown a good safety profile and was generally well tolerated in the first 8 patients with ALS treated with MaaT033 used in a chronic setting. 憲糧淵膚獵壓築襯網糧 (衊積醖淵壓糧衊築顧壓 )	积极	2024-02-29
NCT04150393 (EBMT2023) 人工标引	临床1期	急性髓性白血病	20	MaaT033	餘淵鏇醖醖範齋鏇夢網(襯鹽鏇繭願糧淵遞淵鹽) = 5 serious adverse events (SAEs) were reported in 4 patients: 2 in cohort 2 (hyperkalemia, febrile neutropenia during consolidation), 2 in 1 patient from cohort 3 (colitis & neutropenic colitis during consolidation) and 1 in cohort 4 (enteropathogenic E.coli (EPEC) infectious diarrhea leading to study drug withdrawal) 繭遞壓築獵積製糧餘繭 (積積齋觸膚鹹壓顧衊獵 ) 更多	积极	2023-04-26
NCT04150393 (CIMON, ASH 12022 \| ASH 22022) 人工标引	临床1期	急性髓性白血病	21	MaaT 033	構願繭鹹餘憲廠醖鹽夢(壓艱襯願壓範網鑰鏇膚) = 築艱範顧廠鬱糧壓艱獵積簾鏇襯鹹觸築鑰衊築 (夢淵鑰積鬱膚鏇網網願 )	积极	2022-11-15
NCT04150393 (CIMON, Biospace) 人工标引	临床1期	血液肿瘤	21	MaaT033	壓觸衊齋築積選鑰構繭(選糧壓簾夢鬱糧繭遞鹹) = an infectious diarrhea event with no detection of the causal pathogen in the administered MaaT033 and patient recovery within four days 願衊齋選鹹淵壓築窪選 (築觸淵積淵衊鏇獵齋繭 )	积极	2022-06-02