Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Mechanistic Effects, and Effects on Disease Activity of MH002 in Subjects with Mild to Moderate Ulcerative Colitis: A First-in-human Study - First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis

开始日期2021-12-21

申办/合作机构

MRM Health NV初创企业

100 项与 MH-002 相关的临床结果

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100 项与 MH-002 相关的转化医学

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100 项与 MH-002 相关的专利（医药）

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项与 MH-002 相关的文献（医药）

2021-09-01·Bioorganic Chemistry2区 · 化学

Virtual and experimental high throughput screening of substituted hydrazones on β-Tubulin polymerization

2区 · 化学

Article

作者: Nityananda Shetty, A ; Jayabalan, Karthikeyan ; Xavier, Janet Sabina ; Manoharan, Muthu Tamizh ; Ragavendran, V

Microtubule targeting agents that disrupt the dynamic functioning of the mitotic spindle are some of the best chemotherapeutic agents. Interruption of microtubule dynamics through polymerization or depolymerization causes cell arrest leading to apoptosis. We report a novel class of aroylhydrazones with anticancer properties. Tubulin inhibition studies were performed using both computational and biological methods. Docking and pharmacophore mapping showed efficient binding between the ligands and the protein. Tubulin inhibition assay showed the aroylhydrazones to be inhibitors of tubulin polymerization. DFT studies explains the geometrical and electronic properties of the compounds. Furthermore, anticancer studies using lung and liver cancer cell lines gave low IC₅₀ values with the methyl substituted hydrazone MH-2 being the most potent. (IC₅₀ of 0.0896 and 0.1040 µM respectively). The methyl group is responsible for the effective binding to the protein. Thus, a new class of tubulin binding agents have been identified as potential agents in cancer therapy.

Acta poloniae pharmaceutica

The anticonvulsant, local anesthetic and hemodynamic properties of some chiral aminobutanol derivatives of xanthone.

Article

作者: Marona, Henryk ; Jastrzebska-Wiesek, Magdalena ; Czarnecki, Ryszard

In the present study, several pharmacological tests in animals were carried out to assess potential anticonvulsant, local anesthetic and hemodynamic activity of novel 2- and 4-substituted aminobutanol chiral derivatives of xanthone (hydrochlorides of: (R,S)-2-[(7-chloro)-2-xanthonemethyl)]-N-methylaminobutan-1-ol (MH-2(R,S)), (R,S)-2-(4-xanthonemethyl)-aminobutan-1-ol (MH-20(R,S)) and (R,S)-2-[(6-methoxy)-2-xanthonemethyl]-aminobutan-1-ol (MH-26(R,S)) and their pure enantiomers R and S). The obtained results provided evidence that the most interesting anticonvulsant (in maximal electroshock-test) activity was shown by compound MH-2(R), which in dose 100 mg/kg p.o., protected the mice against tonic cramp of extensors similarly as phenytoin. Moreover, this compound, in concentrations from 0.25 to 1%, also possessed high local anesthetic activity (in infiltration anesthesia), comparable to the reference compound, mepivacaine. All examined compounds suppressed the spontaneous locomotor activity in mice, especially compound MH-2(R,S) and MH-20(R,S), and their enantiomers. The impairment of motor coordination (in chimney test) for applied doses was not observed. Furthermore, compound MH-20(S) at dose corresponding to 1/10 LD50 displayed an interesting hemodynamic activity and significantly decreased systolic and diastolic blood pressure in rats. All examined compounds showed chronotropic negative effect in anesthetized rats ECG record. The most reducing heart frequency was observed for enantiomers S of aminobutanol derivatives of xanthone, especially MH-2(S). The LD50 values of the investigated compounds were comparable with LD50 value of the reference compound in local anesthesia tests--mepivacaine. These studies demonstrated different strength of enantiomers and racemic mixture in carried out tests, where the R enantiomers presented rather central and local anesthetic properties, whereas S enatiomers influenced the hemodynamic activity.

Acta poloniae pharmaceutica

Chiral 2-amino-1-butanol xanthone derivatives as potential antiarrhythmic and hypotensive agents.

Article

作者: Jastrzebska, M ; Librowski, T ; Czarnecki, R

项与 MH-002 相关的新闻（医药）

2024-09-10

·Business Wire

MRM Health Appoints Grégoire Franoux as Chief Business Officer and Adds Ron Robison to its Board of Directors

GHENT, Belgium--( BUSINESS WIRE )-- MRM Health NV, a clinical-stage biopharmaceutical company developing innovative therapeutics for inflammatory, CNS and metabolic diseases, today announced the appointment of Grégoire Franoux, M.B.A., to the newly created role of Chief Business Officer. Concurrently, the company has strengthened its Board of Directors with the appointment of industry veteran Ron Robison, M.D. “ We are excited to have Grégoire join our executive team at this pivotal moment for MRM Health, on the cusp of late-stage clinical development for our lead candidate MH002 in ulcerative colitis and pouchitis, from our proprietary CORAL platform designed to harness the full power of the gut microbiome to develop effective and safe therapeutics,” said Sam Possemiers, Ph.D., Chief Executive Officer of MRM Health. “Grégoire’s extensive expertise in corporate development, combined with his strategic acumen, will be crucial as we continue to advance our pipeline and expand our reach. ” Mr. Franoux will lead the company’s business development and corporate strategy, focusing on forging strategic partnerships and driving growth. He brings 20 years of experience in strategic planning, licensing, business development and corporate finance within the biotechnology sector. He joins MRM Health from Belfius Bank, where he was spearheading Corporate Finance and Capital Markets activities in the Life Sciences sector. Prior to joining Belfius, Gregoire held senior business development positions at Oxurion, Gruenenthal GmbH and Flamel Technologies. He holds an M.S. in Biotechnology from ESIEE Paris, an M.S. in International Finance from IAE Aix-Marseille, and an Executive M.B.A. from INSEAD. “ It is an exciting time to join the MRM Health team as the company makes important progress advancing next-generation LBPs for inflammatory, CNS and metabolic diseases. I look forward to optimizing the value of MRM’s potentially life-altering therapies and delivering them to patients in need ,” commented Grégoire Franoux. In addition, MRM Health welcomes Ron Robison, M.D., to its Board of Directors. Ron, who previously served as Vice President at AbbVie, brings over three decades of experience in drug development and commercialization. Ron also served in global senior pharmaceutical R&D leadership roles at several organizations, including Mallinckrodt Medical, Sanofi/Sterling Winthrop, Nycomed, Amersham Health, Abbott and Head of R&D and Chief Medical Officer at Solvay Pharmaceuticals. Ron has overseen the approval of more than 20 new molecular entities worldwide with over ten innovative clinical indications obtained under FDA breakthrough therapy designation. Dr. Robison holds an M.D. from the Oregon Health Sciences University, an M.S. in Medical Informatics/Biomedical Engineering from the University of Utah, and a B.S. from Oregon State University. MRM Health Chairman Werner Cautreels added, “ We are thrilled to have Ron join our Board. His deep industry knowledge and experience progressing assets through clinical and global regulatory development will be invaluable as we continue to grow and develop potentially transformative therapies. ” -Ends- About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program MH002 is in preparation for pivotal clinical development in Ulcerative Colitis and/or in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL ® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at www.mrmhealth.com .

高管变更突破性疗法

2024-05-15

·BioSpace

MRM Health to Present Positive Clinical Data from MH002 in Ulcerative Colitis at Digestive Disease Week (DDW)

Recent safety and efficacy data in both Ulcerative Colitis and Pouchitis continue to support MH002’s potential in indications characterized by mucosal damage and inflammation. GHENT, Belgium--(BUSINESS WIRE)-- MRM Health NV, a clinical-stage biopharmaceutical company developing innovative therapeutics for inflammatory, CNS and metabolic diseases, today announced it will present positive data for its lead asset, MH002, a live microbial consortium therapy for Inflammatory Bowel Diseases, in two oral presentations during the 2024 Digestive Disease Week® (DDW) meeting, being held May 18-21, 2024 in Washington, D.C. at the Walter E. Washington Convention Center. Late Breaker Presentation Details Session Title: IMIBD Late Breakers and Innovations in IBD Presentation Title: Safety and Efficacy of MH002, an Optimized Live Biotherapeutic Product, for the Treatment of Mild to Moderate Ulcerative Colitis: A First-in-Disease, Double-Blind, Randomized Clinical Trial Presenter: Séverine Vermeire, Ph.D., Principal Investigator and Scientific Advisor of MRM Health Date and Time: Sunday, May 19, 2024, 3:15 PM – 3:30 PM EDT Location: Ballroom B Poster of Distinction Presentation Details Session Title: Microbial Therapies for GI Disease Session Sponsor: AGA Presentation Title: MH002, an Optimized Live Biotherapeutic Product for the Treatment of Inflammatory Bowel Diseases, Has Mode-of-Actions Linked to Restoration of Intestinal Dysbiosis, Mucosal Integrity, and Immune Homeostasis Poster Number: Mo1919 Presenter: Sam Possemiers, Ph.D., Chief Executive Officer of MRM Health Date and Time: Monday, May 20, 2024, 12:30 PM – 1:30 PM EDT This poster has been selected by DDW as a “Poster of Distinction,” recognizing the top 10% of all AGA abstracts selected for poster presentation. Key findings that will be presented include: - The primary endpoint from a placebo-controlled Phase 2a trial in mild-to-moderate Ulcerative Colitis patients was met, with an excellent safety pro tolerance at a fixed dose of 400mg per day over 16 weeks administration. - Initial efficacy on disease activity was evidenced in clinically relevant parameters, including a 12% improvement in Mayo Endoscopic Severity (MES) score (p=0.05, 1-sided Wilcoxon rank sum test), while placebo worsened by 5%. Stool consistency significantly improved in the MH002 treatment group as from week 2 (p=0.006; 1-sided Student t-test). At the end of the eight-week period, 18% of subjects achieved clinical remission compared to 0% of the placebo group (Per-protocol analysis). In contrast to previous trials with other live biotherapeutics in UC, this study was performed successfully without vancomycin preconditioning. - At a mechanistic level, anti-inflammatory effect was demonstrated with a 42% decrease in median fecal calprotectin (a clinically relevant bowel inflammation marker) compared to 18% in placebo at week 8. Furthermore, microbiome restoration occurred in parallel with clinical effects, and differential gene expression analysis showed downregulation of genes involved in inflammation. These findings were in line with the mode-of-action of MH002 and linked to restoration of intestinal dysbiosis, mucosal integrity, and immune homeostasis. -Ends- About MH002 MH002 is currently the most advanced rationally designed live microbial consortium therapy in Inflammatory Bowel Diseases, having demonstrated safety and efficacy in phase 2a trials in both Ulcerative Colitis and Pouchitis. It was developed through MRM Health’s proprietary CORAL® Technology and comprises six well-characterized and safe commensal strains, selected and optimized to tackle key disease-driving mechanisms with enhanced potency, resiliency, and engraftment. MRM Health’s breakthrough scalable and standardized cGMP manufacturing platform allows for the manufacturing of complete consortia as a single drug substance. This ability of CORAL® to enable scalable, cost-effective manufacturing of complete optimized consortia in a single process is expected to provide both key regulatory and patient compliance advantages. About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program MH002 is in preparation for pivotal clinical development in Ulcerative Colitis and/or in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at . View source version on businesswire.com: Contacts For further information please contact: MRM Health Dr Sam Possemiers – CEO Christiane Verhaegen – CFO Tel: +32.9.277.08.50 info@mrmhealth.com Stern Investor Relations Stephanie Ascher Stephanie.ascher@sternir.com +1 212-362-1200 Source: MRM Health View this news release online at:

临床2期临床结果微生物疗法

2024-04-18

·今日头条

聚焦特殊人群：母婴肠道菌群与健康

04月18日的《热心肠日报》，我们解读了 15 篇文献，关注：母婴，营养不良，产后抑郁，多组学，益生菌，膳食纤维，胞外囊泡，儿童便秘，质量，肠神经，结肠憩室，MRM Health，食品用菌种检验，来凯医药，越洋医药，雀巢。该篇日报由R·AI辅助创作生成，人工审核校对。母亲童年营养不良如何影响后代生长发育? Microbiome——[15.5] ① 营养不良导致的线性生长迟缓与不良健康结果相关，且童年经历生长迟缓的母亲更有可能生育生长迟缓的孩子，本研究探究了人类营养不良儿童的肠道菌群对后代生长和免疫功能的影响；② 使用健康或发育迟缓婴儿的菌群移植给无菌小鼠，这些小鼠的子代就继承了亲代的菌群，子代断奶后采用营养不良的饮食，构建出营养不良模型；③ 与健康生长轨迹儿童的肠道菌群相比，营养不良儿童的肠道菌群进行代际定植能导致小鼠后代生长迟缓、营养不良以及肠病免疫特征的发展，如肠绒毛变短、肝脏IGF-1水平降低以及小肠上皮内淋巴细胞和浆细胞的积聚；④ 在断奶后进行肠道菌群定植则对宿主表型影响较小；⑤ 研究结果支持了微生物在断奶阶段对免疫系统的影响对后期免疫功能至关重要的观点，并表明跨代肠道菌群定植是研究早期生命中肠道菌群依赖性生长和免疫变化的有效方法。【原文信息】 Colonization during a key developmental window reveals microbiota-dependent shifts in growth and immunity during undernutrition 2024-04-09 , doi: 10.1186/s40168-024-01783-3 浙大医学院：肠道菌群失调促进产后抑郁症新机制 Brain Behavior and Immunity——[15.1] ① 浙大医学院附属妇产科医院陈新忠团队揭示了肠道菌群失调通过海马体NLRP3介导的神经炎症促进产后抑郁症（PPD），并探究了肠-脑轴在抑郁行为中的潜在作用；② 利用卵巢切除的雌性小鼠构建激素停撤模型模拟人类PPD，发现激素停撤后小鼠出现类抑郁和焦虑行为，同时肠道菌群组成改变；③ 将PPD小鼠粪菌移植（FMT）给抗生素处理的小鼠，受体小鼠出现类抑郁和焦虑行为以及海马体的神经病理变化；④ 从健康小鼠到PPD小鼠的FMT减轻了类抑郁和焦虑行为，降低了NLRP3/caspase-1信号通路介导的炎症，增加了粪便短链脂肪酸（SCFAs）水平，改善了肠道菌群失调（增加产SCFA菌，减少Akk菌）；⑤ 海马体NLRP3的下调减轻了PPD小鼠的类抑郁行为，而海马齿状回NLRP3的过表达在健康小鼠中诱发了类抑郁行为，且来自健康小鼠的FMT未能减轻抑郁行为。【原文信息】 Gut microbiota dysbiosis contributes to depression-like behaviors via hippocampal NLRP3-mediated neuroinflammation in a postpartum depression mouse model 2024-04-08 , doi: 10.1016/j.bbi.2024.04.002 Nature子刊：婴儿及其母系谱系肠道菌群的多组学比较研究 Nature Communications——[16.6] ① 本研究通过多组学方法比较了婴儿肠道菌群及其母系谱系的特征，旨在探究肠道菌群在婴儿期的早期发展；② 利用两种独立的代谢组学平台和宏基因组学研究分析200名个体（包括0-12个月龄婴儿及其母亲和祖母）的粪便样本；③ 婴儿的肠道菌群在种群、功能和代谢组方面与成年人存在显著差异，婴儿的菌群多样性较低，且多种代谢物类别（如短链和支链脂肪酸）具有差异，这些差异与细菌种群的变化有关；④ 本研究为同一代际界限内肠道菌群的塑造提供了创新的生化见解，有助于改善儿童健康结果。【原文信息】 Comparative characterization of the infant gut microbiome and their maternal lineage by a multi-omics approach 2024-04-08 , doi: 10.1038/s41467-024-47182-y 孕期多菌株益生菌对宝宝肠道菌群发育有何影响？ Gut Microbes——[12.2] ① 开展了一项随机、双盲、安慰剂对照试验，探讨了50名孕期肥胖女性使用Vivomixx®多菌株益生菌对其婴儿肠道微生物组（GM）及围产期健康的影响；② 益生菌并未直接改变婴儿GM多样性或特定菌群的丰度，也未通过母婴垂直传递，但在益生菌组中观察到与肥胖相关的产气柯林斯菌属减少；③ 安慰剂组中与代谢健康相关的阿克曼菌属减少，提示母亲GM的间接群落效应可能影响婴儿；④ 出生后3天，婴儿GM受分娩方式和分娩期间使用的抗生素影响，顺产婴儿GM多样性增加，双歧杆菌属和拟杆菌属相对丰度升高，而剖宫产婴儿肠球菌属丰度降低。【原文信息】 Multi-strain probiotics during pregnancy in women with obesity influence infant gut microbiome development: results from a randomized, double-blind placebo-controlled study 2024-04-09 , doi: 10.1080/19490976.2024.2337968 孕期高纤维饮食或补充特定益生菌，可能有益于后代肠道健康 Gut Microbes——[12.2] ① 这项研究发现，孕期补充促进肠道内丁酸生成的调节因子（高纤维饮食或特定益生菌）能够保护后代成年后的结肠炎肠道损伤；② 给怀孕母鼠饲喂高纤维饮食，或者补充乳酸乳球菌乳脂亚种或鼠李糖乳杆菌GG，然后在它们后代成年后诱导慢性结肠炎；③ 孕期高纤维饮食或者补充乳酸乳球菌乳脂亚种，均可减轻结肠炎对后代造成的肠道损伤；④ 这些结果证实了孕期饮食干预可以影响后代的肠道健康，并将孕期饮食定义为增强后代肠道健康的治疗方法。【原文信息】 A high fiber diet or supplementation with Lactococcus lactis subspecies cremoris to pregnant mice confers protection against intestinal injury in adult offspring 2024-04-15 , doi: 10.1080/19490976.2024.2337317 母乳中的胞外囊泡可被新生儿肠道吸收 Journal of Extracellular Vesicles——[16] ① 开发出一套从人乳和新生儿肠道内容物中分离胞外囊泡（HMEVs）的方法，以验证HMEVs是否在新生儿消化过程中存活并被肠上皮细胞吸收；② HMEVs和消化液中的胞外囊泡（dEVs）具有典型的胞外囊泡形态，并富含CD81和CD9蛋白，但不含β-酪蛋白和乳清蛋白；③ HMEV和一些dEV片段含有乳腺来源蛋白BTN1A1，新生儿人类肠绒毛体通过网格蛋白依赖型内吞迅速摄取dEVs；④ 本研究结果表明，新生儿人类肠类器官能迅速吸收dEVs，部分通过胞饮作用进行。【原文信息】 Neonatal enteroids absorb extracellular vesicles from human milk-fed infant digestive fluid 2024-04-11 , doi: 10.1002/jev2.12422 Lancet子刊：12%的亚洲儿童患有便秘（荟萃分析） EClinicalMedicine——[15.1] ① 本系统综述和荟萃分析旨在评估亚洲儿童便秘的流行情况及其相关因素；② 纳入了50项研究，共计311,660名亚洲儿童数据，发现便秘的整体患病率为12.0%；③ 年龄是便秘发生的一个重要影响因素，青少年和1～9岁儿童的便秘患病率显著高于婴儿，但便秘患病率在性别和地理位置上无显著差异；④ 尽管纳入的研究使用了不同的诊断工具或定义导致结果的高度异质性，但本综述增加了关于亚洲儿童便秘的数据；⑤ 本研究揭示了亚洲儿童便秘的高患病率，为制定相关预防策略提供了依据。【原文信息】 Prevalence and determinants of constipation in children in Asia: a systematic review and meta-analysis 2024-04-08 , doi: 10.1016/j.eclinm.2024.102578 Nature子刊：从全球样本看人类肠道中质粒的分布与选择压力 Nature Communications——[16.6] ① 通过分析3467个人类肠道微生物组样本中的11086个质粒，揭示了质粒在人类肠道中的分布主要受到随机扩散的影响，但炎症性疾病会显著改变这一过程；② 仅有20-25%的质粒DNA在各种疾病状态下被选择性地保留，这限制了它们在宿主间的分布；③ 特定的质粒片段因其独特的生态功能而受到选择性压力的影响，这些片段在患有类似健康状况的个体群体中更常共享（如IBD患者）；④ 质粒片段包含重要基因，如铁运输机制，这是IBD的肠道特征标志，影响炎症的严重程度；⑤ 本研究结果强调了质粒作为携带影响细菌宿主和生态系统动态的重要基因库的载体，在人类肠道中的扩散和选择机制。【原文信息】 Plasmids in the human gut reveal neutral dispersal and recombination that is overpowered by inflammatory diseases 2024-04-11 , doi: 10.1038/s41467-024-47272-x Nature子刊：利用肠神经干细胞移植治疗结肠无神经节症的潜力如何？ Nature Communications——[16.6] ① 本研究评估了自体肠神经干细胞移植治疗小鼠结肠无神经节病的可行性和潜力；② 通过注射白喉毒素在小鼠中创造出结肠无神经节模型，从小肠分离出自体肠神经干细胞进行体外扩增和标记后，移植回无神经节的结肠段；③ 移植的肠神经干细胞在体内分化成神经元和胶质细胞，形成新的神经节，可恢复结肠收缩活动，并通过电场刺激和光遗传学得到证实；④ 该研究不仅证明了自体肠神经干细胞治疗结肠无神经节的可行性，也为临床应用这一再生细胞治疗方法奠定了基础。【原文信息】 Autologous cell transplantation for treatment of colorectal aganglionosis in mice 2024-03-20 , doi: 10.1038/s41467-024-46793-9 结肠憩室的基因组和转录组图谱分析 Gut——[24.5] ① 本研究通过基因组和转录组分析揭示了结肠憩室病的遗传和细胞决定因素，为理解其发病机制提供了新见解；② 对404名患有（N=172）和不患有（N=232）结肠憩室病患者的结肠组织进行DNA和RNA测序，发现38个基因表达差异和17个转录本使用变化与结肠憩室病相关，表明组织重塑是憩室形成的主要机制；③ 憩室形成主要与结肠中的基质和上皮细胞有关，包括内皮细胞、肌成纤维细胞、成纤维细胞、杯状细胞、绒毛细胞、肠细胞、神经元和胶质细胞；④ 孟德尔随机化分析发现CCN3、CRISPLD2、ENTPD7、PHGR1和TNFSF13五个基因可能对结肠憩室病有潜在的因果效应，其中憩室病例中证实ENTPD7表达上调；⑤ 结肠憩室病的严重程度与患有憩室炎的遗传倾向正相关。【原文信息】 Genetic and transcriptomic landscape of colonic diverticulosis 2024-03-04 , doi: 10.1136/gutjnl-2023-331267 MRM公布活菌药MH002治疗结肠袋炎2a期临床积极结果 ① 4月16日，MRM Health对外公布了活菌药MH002 2a期临床试验MH002-PC-201研究的顶线阳性结果；② MH002-PC-201研究旨在评估MH002治疗结肠袋炎患者安全性和耐受性问题；③ 研究结果显示，安全性无问题，同时患者临床缓解率达46%；④ MH002是一种由6株肠道共生菌组成的配方菌活菌药，能够修复肠壁屏障功能和重建肠道免疫稳态；⑤ 基于当前监管积极反馈结果，MRM Health公司计划启动MH002治疗溃疡性结肠炎2/3期临床试验。【原文信息】 MRM Health Reports Safety and Positive Efficacy Data in Pouchitis in Phase 2a Clinical Study with MH002 2024-04-17 , Businesswire 《食品用菌种检验鼠李糖乳酪杆菌检验 PMA-qPCR法》团标正式发布 ① 4月1日，由中国食品院牵头起草的《食品用菌种检验鼠李糖乳酪杆菌检验 PMA-qPCR法》团体标准正式发布并实施；② 该标准由中国食品科学技术学会组织起草，伊利、蒙牛和汤臣倍健等多家单位参与；③ 标准的建立是为了对食品用菌种进行精准鉴定和活菌定量，保障产品质量和生产过程一致性控制；④ PMA-qPCR法可准确、稳定、可靠地实现鼠李糖乳酪杆菌的精准鉴定和活菌计数。【原文信息】中国食品院牵头起草的T/CIFST 020-2024《食品用菌种检验鼠李糖乳酪杆菌检验 PMA-qPCR法》团体标准正式发布 2024-04-16 , 中国食品发酵工业研究院来凯医药宣布LAE102新药临床试验获FDA批准 ① 4月15日，来凯医药宣布其用于治疗肥胖症候选药物LAE102的新药临床试验（IND）获FDA批准；② LAE102是一种针对参与调控肌肉再生和脂代谢的新靶点ActRIIA的单克隆抗体；③ LAE102在临床前研究中已显示出增加肌肉减少脂肪的效果，且可与GLP-1受体激动剂联用；④ 2024年第一季度，来凯医药还向中国国家药品监督管理局药品审评中心（CDE）提交了LAE102用于治疗肥胖症的IND申请，并获得受理；⑤ 目前，来凯医药仍在开发其他候选药物，包括LAE103和LAE123，均针对肌肉再生及相关疾病。【原文信息】快讯 | 来凯LAE102肥胖适应症新药临床试验获FDA批准 2024-04-15 , 药智新闻越洋医药与Peptidery公司合作共同进军GLP-1市场 ① 4月8日，越洋医药与美国Peptidery公司在江苏泰州中国医药城签署产品战略合作协议；② 双方将结合各自技术和资源优势，共同推进GLP-1合作产品在全球的研发和商业化；③ Peptidery是一家专注于多肽药物创新、研发与生产的公司，致力于提供高质量、安全、有效的多肽产品；④ 越洋医药主营业务包括开发针对美国和中国市场的2类新药，帮助国内外客户提高NCE的成药性，为国内外客户开发缓控释新药及仿制药。【原文信息】越洋医药与美国药企签署战略合作协议共同进军GLP-1 2024-04-15 , 越洋医药雀巢青岛超高温灭菌奶项目奠基 ① 4月12日，雀巢青岛在莱西食品产业集聚区庆祝其成立30周年并奠基超高温灭菌奶项目；② 新增资扩产的高温灭菌奶项目总投资16亿元，计划分三期实施；③ 其中，一期预计于2025年6月投产，旨在提升奶制品生产能力；④ 该项目将满足国内增长的消费需求，进一步优化产业结构，并促进当地乳制品产业发展；⑤ 雀巢青岛自1994年成立以来，已建立液体乳和速溶咖啡生产基地及相关研发中心。【原文信息】雀巢青岛30周年庆暨超高温灭菌奶项目奠基 2024-04-15 , Foodaily 感谢本期日报的审核者：章台柳，RZN，圆圈儿，九卿臣，注册营养师陈彬林，Richard，lxx，Alex Zhang 点击阅读过去10天的日报： 0417 | 高分Nature子刊：汇集全球玩家力量，助力肠道微生物研究 0416 | 多文聚焦：保卫肠道，免疫细胞和菌群谁都不能少 0415 | Cell重磅综述：系统解析癌症复杂性，菌群作用不容小觑 0414 | 高分Cell子刊综述，一文讲透发酵食品 0413 | 3篇子刊重磅文章，解析微生物组治疗的现状与未来 0412 | 10文聚焦国内团队新成果，肠道和菌群研究多点开花 0411 | 今日Nature：抵御病菌感染，结肠细胞如何与T细胞协作？ 0410 | 今日Cell：首个大规模泛癌转移瘤菌群图谱重磅出炉 0409 | 高分Nature子刊：菌群产物药物研发取得新进展 0408 | 300万人数据："好"胆固醇与消化道癌症风险有何关联？

微生物疗法临床研究

100 项与 MH-002 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
隐窝炎	临床2期	比利时	MRM Health NV初创企业	2022-07-27
溃疡性结肠炎	临床前	波兰	MRM Health NV初创企业	2021-09-23
溃疡性结肠炎	药物发现	捷克	MRM Health NV初创企业	2021-09-23

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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


EUCTR2020-004355-33-BE (MH002-UC-201, Biospace) 人工标引	临床2期	溃疡性结肠炎	45	MH002 400mg	(糧壓鏇製鹽餘觸網鹹簾) = 鏇顧齋襯觸繭襯廠壓鏇窪醖鹽憲壓蓋夢鹽鑰顧 (窪獵製鏇範觸醖餘網衊 ) 更多	积极	2023-09-19
				Placebo	(糧壓鏇製鹽餘觸網鹹簾) = 鹹憲膚鹹積簾願構醖製窪醖鹽憲壓蓋夢鹽鑰顧 (窪獵製鏇範觸醖餘網衊 ) 更多