An open-label single-arm treatment extension study to evaluate the long-term efficacy and safety of Oxabact® for patients with primary hyperoxaluria who completed study OC5-DB-02 - ePHex OLE

开始日期2019-07-16

申办/合作机构-

NL-OMON47491 / Completed临床3期

A phase III double-blind, randomized study to evaluate the long-term<br>efficacy and safety of Oxabact® in patients with primary hyperoxaluria - ePHex

开始日期2018-01-09

申办/合作机构-

NCT03116685 / Completed临床3期

A Phase III Double-blind, Randomised Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

This study will evaluate the efficacy and safety of OC5 in patients with PH.

开始日期2018-01-09

申办/合作机构

OxThera AB

100 项与 Lyophilised Oxalobacter formigenes(OxThera AB) 相关的临床结果

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100 项与 Lyophilised Oxalobacter formigenes(OxThera AB) 相关的转化医学

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100 项与 Lyophilised Oxalobacter formigenes(OxThera AB) 相关的专利（医药）

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项与 Lyophilised Oxalobacter formigenes(OxThera AB) 相关的文献（医药）

2023-02-01·Pediatric Nephrology3区 · 医学

ePHex: a phase 3, double-blind, placebo-controlled, randomized study to evaluate long-term efficacy and safety of Oxalobacter formigenes in patients with primary hyperoxaluria

3区 · 医学

Article

作者: Boussetta, Abir ; Hunley, Tracy E ; Collard, Laure ; Gould, Edward ; Ariceta, Gema ; Jarraya, Faical ; Banos, Ana ; De, Sudarsana ; Schalk, Gesa ; Fraga, Gloria ; Abroug, Saoussen ; Ben Hmida, Mohamed ; Dehmel, Bastian ; Moochhala, Shabbir H ; Lindner, Elisabeth

AbstractBackgroundPrimary hyperoxalurias (PHs) are rare genetic diseases that increase the endogenous level of oxalate, a waste metabolite excreted predominantly by the kidneys and also the gut. Treatments aim to improve oxalate excretion, or reduce oxalate generation, to prevent kidney function deterioration. Oxalobacter formigenes is an oxalate metabolizing bacterium. This Phase III, double-blind, placebo-controlled randomized trial investigated the effectiveness of orally administered Oxabact™, a lyophilized O. formigenes formulation, at reducing plasma oxalate levels in patients suffering from PH.MethodsSubjects (≥ 2 years of age) with a diagnosis of PH and maintained but suboptimal kidney function (mean estimated glomerular filtration rate at baseline < 90 mL/min/1.73 m2) were eligible to participate. Subjects were randomized to receive Oxabact or placebo twice daily for 52 weeks. Change from baseline in plasma oxalate concentration at Week 52 was the primary study endpoint.ResultsForty-three subjects were screened, 25 were recruited and one was discontinued. At Week 52, O. formigenes was established in the gut of subjects receiving Oxabact. Despite decreasing plasma oxalate level in subjects treated with Oxabact, and stable/increased levels with placebo, there was no significant difference between groups in the primary outcome (Least Squares mean estimate of treatment difference was − 3.80 μmol/L; 95% CI: − 7.83, 0.23; p-value = 0.064). Kidney function remained stable in both treatments.ConclusionsOxabact treatment may have stabilized/reduced plasma oxalate versus a rise with placebo, but the difference over 12 months was not statistically significant (p = 0.06). A subtle effect observed with Oxabact suggests that O. formigenes may aid in preventing kidney stones.Graphical abstractA higher resolution version of the Graphical abstract is available as Supplementary information.

2021-07-23·Nephrology Dialysis Transplantation2区 · 医学

Effects of Oxalobacter formigenes in subjects with primary hyperoxaluria Type 1 and end-stage renal disease: a Phase II study

2区 · 医学

Article

作者: Banos, Ana ; Herberg, Ulrike ; Pellikka, Patricia A ; Dehmel, Bastian ; Hoppe, Bernd ; Lindner, Elisabeth

AbstractBackgroundIn primary hyperoxaluria Type 1 (PH1), endogenous oxalate overproduction significantly elevates urinary oxalate excretion, resulting in recurrent urolithiasis and/or progressive nephrocalcinosis and often early end-stage renal disease (ESRD). In ESRD, dialysis cannot sufficiently remove oxalate; plasma oxalate (Pox) increases markedly, inducing systemic oxalate deposition (oxalosis) and often death. Interventions to reduce Pox in PH1 subjects with ESRD could have significant clinical impact. This ongoing Phase II, open-label trial aimed to evaluate whether long-term Oxabact™ (Oxalobacter formigenes, OC5, OxThera Intellectual Property AB, Sweden) lowers Pox in PH1 ESRD subjects, ameliorating clinical outcome.MethodsPH1 ESRD subjects on stable dialysis regimens were examined. Subjects were administered one OC5 capsule twice daily for up to 36 months or until transplantation. Total Pox values, cardiac function and safety were evaluated. Free Pox was evaluated in a comparative non-treated PH1 dialysis group using retrospective chart reviews and analyses.ResultsTwelve subjects enrolled in an initial 6-week treatment phase. Following a washout of up to 4 weeks, eight subjects entered a continuation study; outcomes after 24 months of treatment are presented. After 24 months, all subjects had reduced or non-elevated Pox compared with baseline. Cardiac function improved, then stabilized. No treatment-related serious adverse events were reported.ConclusionsCompared with an untreated natural control cohort, 24 months OC5 administration was beneficial to PH1 ESRD subjects by substantially decreasing Pox concentrations, and improving or stabilizing cardiac function and clinical status, without increasing dialysis frequency. OC5 was safe and well-tolerated.

2020-06-01·Biological Trace Element Research3区 · 生物学

Antimicrobial, Antioxidant and Larvicidal Activities of Spherical Silver Nanoparticles Synthesized by Endophytic Streptomyces spp.

3区 · 生物学

Article

作者: Hassan, Saad El-Din ; Fouda, Amr ; El-Gamal, Mamdouh S ; Abdo, Abdullah M

In this study, metabolites involved in the free-biomass filtrates for three endophytic actinomycetes of Streptomyces capillispiralis Ca-1, Streptomyces zaomyceticus Oc-5, and Streptomyces pseudogriseolus Acv-11 were used as biocatalysts for green synthesis of silver nanoparticles (Ag-NPs). Characterization of biosynthesized Ag-NPs was accomplished using UV-Vis spectroscopy, X-ray diffraction patterns (XRD), Fourier transform infrared spectroscopy (FT-IR), scanning electron microscopy (SEM-EDX), transmission electron microscopy (TEM), and particle size analyzer. The biosynthesized Ag-NPs showed maximum surface plasmon resonance (SPR) at 440 for strain Ca-1 and 450 for both strains of OC-5 and Acv-11. Nanoparticle spherical shape was recorded with size ranging from 23.77 to 63.14 nm, 11.32 to 36.72 nm, and 11.70 to 44.73 nm for Ca-1, Oc-5, and Acv-11, respectively. SEM-EDX analysis exhibited the weight percentages of 17.3, 22.3, and 48.7% for Ag-NPs synthesized by strains Ca-1, Oc-5 and Acv-11, respectively. The activities of biosynthesized Ag-NPs were concentration dependent and the obtained results confirmed the efficacy of Ag-NPs as antimicrobial agents against Gram-positive and Gram-negative bacteria as well unicellular and multicellular fungi. The MIC for Gram-positive bacteria, Gram-negative bacteria (E. coli), and eukaryotic microorganisms was 0.25 mM with clear zone ranging from 10.3 to 14.6 mm, while MIC for Pseudomonas aeruginosa was 1.0 mM for Ag-NPs synthesized by strain Ca-1 and 0.25 mM for those synthesized by strains Oc-5 and Acv-11. Moreover, Ag-NPs exhibited antimicrobial activity against four plant pathogenic fungi represented by Alternaria alternata, Fusarium oxysporum, Pythium ultimum, and Aspergillus niger at 2.0, 1.5, 1.0, and 0.5 mM of Ag-NPs with different degree. In vitro assessment of the antioxidant efficacy of biosynthesized Ag-NPs was achieved by scavenging assay of H₂O₂, reducing power of Fe³⁺, or total antioxidant assay. The results showed that antioxidant activities of Ag-NPs were concentration dependent with the highest activity at Ag-NP concentration of 2.0 mM. Furthermore, the biosynthesized NPs have prospective bioinsecticidal activity against Culex pipiens and Musca domestica. Green synthesis of NPs could be quite potential for the development of new bioactive compounds used in different biomedical applications.

项与 Lyophilised Oxalobacter formigenes(OxThera AB) 相关的新闻（医药）

2023-10-13

·CPHI制药在线

研发 | 浅谈原发性高草酸尿症治疗进展

关注并星标CPHI制药在线原发性高草酸尿症（PH）是一种常染色体隐性遗传病，临床上以尿草酸排泄增加、反复草酸钙尿石形成、肾钙质沉着和全身不溶性草酸盐沉积为特征。PH发病是因基因突变导致肝脏产生过量草酸引起，根据基因突变类型的不同，PH可分为3型。其中Ⅰ型PH（PH1）与2号染色体上AGXT 基因突变有关。AGXT基因编码丙氨酸乙醛酸转氨酶(AGT)，该酶可将乙醛酸转化为甘氨酸，其缺乏可使乙醛酸在细胞质中积聚，从而导致乙醇酸和草酸增多。 Ⅱ型PH（PH2）与10号染色体上GRHPR基因突变有关。GRHPR基因编码乙醛酸羟基丙酮酸还原酶 (GRHPR)，该酶可将乙醛酸转化为乙醇酸，其缺乏会导致乙醛酸积聚，最终被乳酸脱氢酶 (LDH) 转化为草酸。 Ⅲ型PH（PH3）与9号染色体上HOGA1基因突变有关。HOGA1基因编码4-羟基2-酮戊二酸醛缩酶，其缺乏会限制4-羟基2-酮戊二酸转化为乙醛酸，这将使更多的酮戊二酸转向草酸途径。这三种类型中，PH1最常见且最严重，约占80%，据统计全球约有5.8万例PH1患者。而PH2和PH3分别占10%。目前，PH治疗手段有限，包括药物/保守治疗、透析治疗、肝肾联合移植等。其中肝肾联合移植治疗效果有限，且复发率高，患者需要终身免疫抑制以防止器官排斥。治疗药物方面，PH患者直到2020年才迎来首款药物，即Alnylam制药公司的Oxlumo(Lumasiran)。该药是一种皮下给药的RNA干扰(RNAi)疗法，其靶向编码乙醇酸氧化酶的HAO1基因，通过沉默HAO1，从而耗尽乙醇酸氧化酶，抑制草酸的生成。2020年11月，该药被FDA批准用于治疗PH1，以降低儿科和成人患者的尿草酸盐水平。2022年11月，该药又被FDA批准用于治疗PH1，以降低儿童和成人患者的尿草酸盐和血浆草酸盐水平。今年9月，FDA又批准一款PH新疗法，即诺和诺德的Rivfloza（Nedosiran）。该药是Dicerna利用专有GalXC™RNAi技术平台开发的RNAi疗法，通过与表达肝乳酸脱氢酶（LDH）的mRNA结合发挥作用。2021年11月，诺和诺德通过收购Dicerna，将nedosira纳入囊中。已公布的2期临床试验PHYOX™结果显示：接受Nedosiran治疗的PH患者（包括PH1和PH2）的尿草酸盐排泄量与基线差值相较于安慰剂组具有统计学意义(p＜0.0001)差异。而且，与安慰剂相比，接受Nedosiran治疗的患者在第90天后两次或更多次连续随访时达到并维持正常或接近正常Uox水平的比例显著更高（p=0.0025）。 Lumasiran和Nedosiran均属于RNAi疗法，但适应症稍有差异，Nedosiran适应症人群更加广泛，不局限于PH1患者。此外，目前全球还有几款在研PH新疗法，如Chinook Therapeutics的CHK-336、OxThera的Oxabact、BridgeBio的BBP-711。其中CHK-336是一款肝脏靶向的口服LDHA抑制剂，在PH1小鼠模型实验中能有效地将尿液中草酸含量降至正常水平，且展现出良好的安全性。已公布的CHK-336治疗PH和其他肾结石疾病的1期临床试验结果显示：CHK-336通常耐受性良好，具有良好的药代动力学特征，其半衰期支持每日一次的给药频率。而且，研究人员利用新型示踪剂证明了CHK-336能够阻断健康受试者肝脏草酸盐的生成。值得一提的是，今年6月，诺华斥资35亿美元收购Chinook Therapeutics，将包括CHK-336在内的多款药物纳入囊肿。 Oxabact是一种双模式肠道生物疗法，是含有产甲草酸杆菌的冻干制剂，以包衣胶囊形式口服给药。通过促进草酸盐从血浆主动和被动分泌到肠道，Oxabact能够增加草酸盐的排泄。遗憾的是，2021年6月，OxThera宣布Oxabact治疗PH的关键3期临床试验OC5-DB-02错失主要终点。 BBP-711是一种口服给药的乙醇酸氧化酶 (GO) 小分子抑制剂。靶向GO是一种经过临床验证的方法，可通过降低乙醛酸的浓度来减少尿中的草酸。BBP-711治疗高草酸尿症的首次人体1期试验已于2021年5月启动。整体来看，PH领域还存在很大未满足的市场需求，虽然诺和诺德Rivfloza已于近日获批。期待随着企业的不懈努力，PH领域可以早期迎来更多新疗法。扫码参与制药在线周年庆游园会来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

临床2期临床结果并购信使RNA临床3期

2023-07-22

·药渡Daily

微生物组疗法接连获批上市，能否成为新药研发的下一座”金矿“？

人体是数以万计的微生物的家园。所谓微生物组是众多微生物及其基因和代谢物的复杂集合体，它们定殖在消化道、皮肤、口腔、泌尿生殖系统。而微生物组疗法则是将微生物作为活性物质用于治疗或预防疾病的一种新兴疗法。过去，制药企业一直未能开发出用于调节患者微生物组的疗法；但近期，微生物组疗法已迎来了转机：2022年11月，辉凌制药的REBYOTA获得美国FDA批准上市。2022年11月，BiomeBank Bioscience公司的BIOMICTRA获得澳大利亚医疗用品管理局（TGA）批准上市。2023年4月，Seres Therapeutics公司的Vowst（SER-109）获批上市，这也是FDA批准上市的首款口服微生物组疗法。以上三款药物均用于治疗复发性艰难梭菌感染。作为新兴疗法，微生物组疗法是否能成为新药研发的下一座“金矿”？答案是肯定的。微生物与健康，是一个宏达、且远未被了解的生物学领域。新疗法的获批上市也表明部分地区的监管机构对这一新兴疗法的处理方式已非常成熟。目前来看，新上市的第一代微生物组疗法仅切入了一个相对较小的目标市场（即复发性艰难梭菌感染），然而，微生物组疗法的涉及领域正在迎来范式的转变，自身免疫、肿瘤甚至是神经系统疾病，均有可能成为微生物组疗法的下一个突破点，一旦成功，未来将不可估量。初识微生物组疗法微生物组疗法，又被成为活体菌药物（live biotherapeutic products, LBPs），根据制造方法的不同，目前活体菌药物主要分为四大类：粪菌移植、单菌株药物、工程菌株以及小分子微生态调节剂。01粪菌移植粪菌移植（Fecal Microbiota Transplantation, FMT），是指将健康人群粪便中的微生物菌群移植到患者胃肠道内，通过重建新的肠道菌群以实现治愈疾病的疗法。目前已获批上市的3款微生物组疗法均是基于FMT开发的，此外，全球多家公司正在布局FMT新药。FMT疗法研发情况（列举）资料来源：《中国生命科学》2023年3月第3期，作者整理02单菌株药物单菌株药物，包括单菌株或者混合株药物单菌药物，也有开发少数复合菌的项目。目前的单菌疗法中有少数品种是食品益生菌菌株（例如，罗伊斯乳杆菌、动物双歧杆菌等）按药物标准进行再研发，但更多的品种是采用未有人体使用历史的新菌株（例如，脆弱拟杆菌、鹑鸡肠球菌、克里斯滕森菌等）。据统计，单菌疗法占活体生物新药研发总数的一半左右。目前，已有3款单菌株药物进入临床3期研究阶段：Infant Bacterial Therapeutics公司的IBP-9414（一种罗伊氏乳杆菌）用于治疗婴儿溃疡性结肠炎；Probi公司的LP299V（一种乳酸菌）用于治疗移植物抗宿主病；Ox Thera公司的Oxabact（一种草酸盐还原菌）用于治疗原发性高草尿酸症。03工程菌株药物工程菌株是指用基因工程方法，使外源基因获得高效表达的菌株。工程菌是采用现代生物工程技术加工出来的新型微生物，具有多功能、高效和适应性强等特点。相较于FMT和单菌株疗法，工程菌药物研发起步略晚，大部分药物处于临床早期阶段。其中，具有代表性的有 Advaxis公司的ADXS-503（一种减毒单核细胞增多性李斯特菌），联合帕博利珠单抗治疗非小细胞肺癌，目前处于临床II期阶段，I/II期试验结果显示，ADXS-503可让患者产生可观的应答率和疾病控制率，且患者的临床获益具有持续性：14名既往使用过帕博利珠单抗的患者，联合使用ADXS-503后，客观缓解率达14%，疾病控制率达36%；在另一研究中，将ADXS-503用于未接受过全身治疗、PD-L1≥50%且EGFR/ALK阴性患者，结果显示在3名接受联合治疗的新诊断的非小细胞患者中，疾病控制率为67%，两名患者疾病稳定分别达332天和94天。ADXS-503临床数据资料来源：Advaxis Corporate Presentation，202204小分子微生态调节剂小分子微生态调节剂（small molecule microbiome modulator, SMMM）是指能选择性地促进宿主肠道内的有益细菌生长繁殖的物质，通过促进有益菌的繁殖，抑制有害细菌的生长，达到调整肠道菌群，从而促进机体健康。该领域的代表公司有 Second Genome、Enterome等。Second Genome公司的SGM-1019用于治疗非酒精性脂肪性肝炎，目前处于临床II期；Enterome公司的EB8018用于治疗炎症性肠病，处于临床II期阶段。微生物组疗法的新机遇从单一疾病向多疾病领域延伸据作者不完全统计，全球进入临床阶段的微生物组药物有103个，其中：影响肠道的自身免疫类疾病是目前最常见的适应症，占全部微生物疗法研发管线的35%，其中炎症性肠病（包括溃疡性结肠炎和克罗恩病）是主要的目标疾病。复发性艰难梭菌感染是目前微生物组临床研发中最大的单一疾病领域，占比达12%。肿瘤或将成为微生物组疗法的下一个研发重点，目前占研发管线总量的20%。PD-1等免疫检查点抑制剂通过阻断免疫检查点恢复或增强机体的抗肿瘤免疫，但存在某些免疫检查点抑制剂应答率偏低、继发性耐药等不良反应。相关研究表现，肠道微生物组会影响免疫检查点抑制剂的疗效，因此，微生物组疗法联合免疫检查点抑制剂，成为目前LBP药物开发的热点之一。微生物组疗法在研管线情况资料来源：IQVIA，作者整理微生物组疗法联合免疫检查点抑制剂研发情况资料来源：广东省活体生物药工程技术研究中心此外，越来越多研究显示肠道菌群与神经系统疾病的产生存在相关关系，脑-肠轴是一个双向交流路径，通过此路径，细菌代谢物可以进入脑，影响神经发育或产生神经炎症，这些代谢物被认为与神经退行性疾病有关，例如阿尔茨海默病，帕金森病，自闭症等。综上所述，粪菌移植仅仅是第一代微生物组疗法，未来伴随着微生物组在疾病病理中的作用机制证据不断增加，微生物组疗法将有望在肿瘤、自身免疫、代谢类疾病甚至是神经系统再下一城。微生物组疗法的挑战研发失败、监管仍处于探索阶段作为新兴事物，微生物组疗法充满机遇，但同时也伴随着风险和挑战。由于大多数复杂疾病的发病机制与微生物间的因果关系尚未明确，不少企业因为临床研究效果欠佳而选择终止某些药品的临床研究或直接关停微生物组管线，例如，由于反应率过低，Seres Therapeutics公司中断了SER-401研发，Vedanta停止其VE800药物临床试验。因此，对于试图布局微生物组疗法的企业来说，仍需开展大量的基础研究，明确在疾病发生和进展中，起到关键性作用的某种或某类菌群。其次是监管方面的问题。2016年，FDA发布了《活体生物药的早期临床试验：化学､制造和控制信息》，这是首个关于LBP药物研发指南，FDA对于LBP药物的监管体系已较为成熟。然而，不同地区的监管环境存在差异化，例如，欧盟没有制定欧洲通用的“微生物组疗法”明确法规，而是交由各成员国自己来决定。国内而言，目前对于LBP药物的监管尚处于探索阶段，中华医学会仅在肠道菌群捐献者管理、治疗质量管理、减少不良事件以及促进标准化方面达成了专家共识。未来一段时期内，随着国内新LBP药物的陆续上市申报，国内LBP药物的研发、技术审评和监管也将逐步积累更多经验。微生物组疗法为疾病治疗开辟了一个新天地。大量正处于临床后期的LBP药物正在不断推进，未来几年，微生物组疗法市场将逐渐发展成熟，谁又能在这新生的、不断发展的市场中领航，我们拭目以待。参考资料《国际活体生物药临床开发进展（2019-2021年）》，广东省活体生物药工程技术研究中心《内有乾坤：微生物组疗法的不断发展》，IQVIA，2023年《活体菌药物产业化》，《中国生命科学》2023年3月第3期Advaxis Corporate Presentation，2022药物临床试验登记与信息公示平台，ClinicalTrials.gov，公司官网END👇关注药渡数据媒体矩阵

微生物疗法临床3期上市批准

2022-06-09

·PRNewswire

Global Human Microbiome Market Research Report 2022: Current Market Landscape, Likely Adoption of Microbiome-Based Therapeutics, Diagnostics and FMTs Over the Next Decade

DUBLIN, June 9, 2022 /PRNewswire/ -- The "Human Microbiome Market: Focus on Therapeutics, Diagnostics and Fecal Microbiota Therapy: Distribution by Type of Molecule, Type of Product, Target Indication, Therapeutic Areas, Supply Channels and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering. The 'The Human Microbiome Market (4th Edition), 2022-2035' report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of microbiome-based therapeutics, diagnostics and FMTs, over the next decade. The report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. One of the key objectives of the report was to estimate the existing market size and future growth opportunity for microbiome therapeutics, diagnostics and FMTs, over the next decade. The research, analyses and insights presented in this report are based on revenue generation trends of the sales, of approved / late stage (estimated) microbiome therapeutics, diagnostic products and FMTs. The report also features the likely distribution of the current and forecasted opportunity within microbiome therapeutics market across type of molecule (small molecule and biologics), type of product (probiotic and other drug), target indication (graft versus host disease, necrotizing enterocolitis, primary hyperoxaluria and recurrent CDI ), therapeutic area (digestive and gastrointestinal disorders, infectious diseases and rare disorders), route of administration (oral and rectal), key geographical regions. In order to account for the uncertainties associated with the growth of microbiome market and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth. The ongoing research efforts, focused on targeting and modulating microbiome, have led to the development of treatment options for more than 25 indications. In addition, probiotic therapies with live biotherapeutic products (microbes) are considered to be the most advanced microbiome-based therapies for restoring bacterial symbiosis. At present, fecal microbiota transplantation (FMT) involving the transfer of complete microbial community from a healthy donor's feces to recipient via oral (in form of a capsule) or rectal (enema and colonoscopy) is the only FDA-approved microbiome therapy, for the treatment of recurrent CDI. However, several players are engaged in developing prescription drugs modulating human microbiome for the treatment of various gastrointestinal and non-gastrointestinal disorders as well. Further, a number of microbiome diagnostic and screening / profiling tests are commercially available for the detection of different microbiome-related diseases. It is worth mentioning that, owing to the rising interest, a number of start-ups / small firms have established in the past few years and the contributions of big pharma players have fueled the overall growth in this domain. Driven by increasing prevalence of disease indications, promising therapeutic potential of microbiome-based therapies, encouraging clinical trial results and financial support from the investors, the human microbiome therapeutics and diagnostics market is likely to witness substantial growth in the mid to long-term. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company / organization names): Lee Jones (President and Chief Executive Officer, Rebiotix) Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic) Colleen Cutcliffe (Co-founder and Chief Executive Officer, Pendulum Therapeutics) Nikole Kimes (Co-founder and Chief Executive Officer, Siolta Therapeutics) James Burges (Co-founder and Vice President of Innovation, Finch Therapeutics) JP Benya (Vice President, Operations, Flame Biosciences) Debbie Pinkston (Former Vice President, Sales and Business Development, List Biological Laboratories) Gregory J Kuehn (Vice President, Business Development and Marketing, Metabiomics) Mark Heiman (Chief Scientific Officer and Vice President, Research, Scioto Biosciences) Alexander Segal (Founder, Stealth Startup) Assaf Oron (Chief Business Officer, BiomX) Pierre-Alain Bandinelli (Chief Strategy Officer, Da Volterra) Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical) Aaron Wright (Senior Scientist, Pacific Northwest National Laboratories) Nicholas Monsul (Co-founder and Chairman, Quorum Innovations) Charlie Badham (Senior Manager, Corporate Development, 4D Pharma) Key Questions Answered Who are the leading players engaged in the development of microbiome therapeutics? Which are the key drugs being developed across various stages of development? Which companies are actively involved in conducting clinical trials for microbiome therapeutics and FMTs? Who are the leading players engaged in the development of microbiome diagnostics and screening / profiling tests? What kind of partnership models are commonly adopted by industry stakeholders? Who are the key investors active in the field of human microbiome therapeutics and diagnostics? What are the different initiatives undertaken by big pharma players for the development of human microbiome therapeutics in the recent past? What is the role of various start-ups engaged in the developing human microbiome therapeutics? Which are the most commonly targeted therapeutic indications for microbiome therapeutics are being developed? What are the various steps involved in the manufacturing of microbiome therapeutics and what are the key considerations for selecting a CMO / CRO? What are the various algorithms / tools used to analyze data generated from microbiome research? How is the current and future opportunity, related to microbiome therapeutics, diagnostics and FMT likely to be distributed across key market segments? What are the various non-pharma applications of microbiome products? Key Topics Covered: 1. PREFACE 1.1. Scope of the Report 1.2. Research Methodology 1.3. Key Questions Answered 1.4. Chapter Outlines 2. EXECUTIVE SUMMARY 3. INTRODUCTION 3.1. Chapter Overview 3.2. Concept of Microbiota and Microbiome 3.3. Overview of Gut Flora 3.4. The Microbiome and Associated Diseases 3.5. Impact of Microbiota on Drug Pharmacokinetics 3.6. Impact of Microbiota on Therapeutic Outcomes 3.7. Microbiome Therapeutics 3.8. The Human Microbiome Project (HMP) 3.9. Regulatory Guidelines for Live Biotherapeutic Products (LBPs) 3.10. Key Challenges Associated with the Development of Microbiome Therapeutics 3.11. Future Perspectives 4. MICROBIOME THERAPEUTICS: MARKET LANDSCAPE 4.1. Chapter Overview 4.2. Microbiome Therapeutics: Clinical Pipeline 4.3. Microbiome Therapeutics: Preclinical Pipeline 4.4. Microbiome Therapeutics: List of Drug Developers 5. MICROBIOME THERAPEUTICS: COMPANY AND DRUG PROFILES 5.1. Chapter Overview 5.2. Microbiome Therapeutics Developers: Companies with Candidate(s) in Highest Phase of Development 5.3. Finch Therapeutics 5.4. Infant Bacterial Therapeutics 5.5. MaaT Pharma 5.6. OxThera 5.7. Rebiotix (acquired by Ferring Pharmaceuticals) 5.8. Seres Therapeutics 5.9. Microbiome Therapeutics Developers: Companies with Maximum Number of Therapeutic Programs 5.10. 4D Pharma 5.11. Biosortia Pharmaceuticals 5.12. Qu Biologics 5.13. Servatus 6. CLINICAL TRIAL ANALYSIS: HUMAN MICROBIOME THERAPEUTICS 6.1. Chapter Overview 6.2. Human Microbiome Therapeutics: List of Clinical Trials 7. MICROBIOME DIAGNOSTICS AND SCREENING / PROFILING TESTS: MARKET LANDSCAPE 7.1. Chapter Overview 7.2. Overview of Microbiome Diagnostics and Screening / Profiling Tests 7.3. Microbiome Diagnostics and Screening / Profiling Tests: Marketed and Under Development Products 7.4. Microbiome Diagnostic and Screening / Profiling Tests Providers 8. MICROBIOME DIAGNOSTIC AND SCREENING / PROFILING TEST PROVIDERS: COMPANY PROFILES 8.1. Chapter Overview 8.2. Shoreline Biome 8.3. DNA Genotek 8.4. Invivo Healthcare 8.5. GoodGut 8.6. BiomeDx 9. FECAL MICROBIOTA THERAPY (FMT) 9.1. Chapter Overview 9.2. Introduction to Fecal Microbiota Therapy 9.3. Historical Overview 9.4. Fecal Microbiota Therapy: Procedure and Clinical Relevance 9.5. Regulatory Guidelines Related to Fecal Microbiota Therapy 9.6. Insurance Coverage for Fecal Microbota Therapy 9.7. Fecal Microbiota Therapy: Marketed and Development Pipeline 9.8. Fecal Microbiota Therapy: List of Developers 9.9. Stool Banks 10. CLINICAL TRIALS ANALYSIS: FECAL MICROBIOTA THERAPY 10.1. Chapter Overview 10.2. List of Clinical Trials 11. ATTRACTIVENESS COMPETITIVENESS (AC) MATRIX 11.1. Chapter Overview 11.2. AC Matrix: An Overview 11.3. AC Matrix: Analytical Methodology 11.4. AC Matrix: Plotting the Information 11.5. AC Matrix: Analyzing the Data 11.6. Concluding Remarks 12. MICROBIOME RELATED INITIATIVES OF BIG PHARMA PLAYERS 12.1. Chapter Overview 12.2. Scope and Methodology 12.3. Initiatives of Big Pharma Players 12.4. Benchmarking Analysis of Big Pharma Players 13. START-UP HEALTH INDEXING 13.1. Chapter Overview 13.2. Scope and Methodology 13.3. Benchmarking of Start-ups 14. KEY THERAPEUTIC AREAS 14.1. Chapter Overview 14.2. Metabolic Disorders 14.3. Digestive and Gastrointestinal Disorders 14.4. Oncological Indications 14.5. Dermatological Disorders 14.6. Infectious Diseases 15. PARTNERSHIPS AND COLLABORATIONS 15.1. Chapter Overview 15.2. Partnership Models 15.3. Human Microbiome: List of Partnerships and Collaborations 15.4. Analysis by Year of Partnership 15.5. Analysis by Type of Partnership 15.6. Analysis by Year and Type of Partnership 15.7. Analysis by Type of Product 15.8. Analysis by Target Indication 15.9. Analysis by Therapeutic Area 15.10. Analysis by Type of Company 15.11. Analysis by Type of Partner 15.12. Most Active Players: Analysis by Number of Partnerships 15.13. Intercontinental and Intracontinental Agreements 16. FUNDING AND INVESTMENT ANALYSIS 16.1. Chapter Overview 16.2. Types of Funding 16.3. Microbiome Therapeutics and Diagnostics: List of Funding and Investments 17. CASE STUDY: CONTRACT SERVICES FOR MICROBIOME THERAPEUTICS AND LIVE BIOTHERAPEUTICS 17.1. Chapter Overview 17.2. Manufacturing Microbiome Therapeutics 17.3. Key Considerations for Selecting a CMO / CRO Partner 18. BIG DATA AND MICROBIOME THERAPEUTICS 18.1. Chapter Overview 18.2. Introduction to Big Data 18.3. Internet of Things (IoT) 18.4. Growing Interest in Big Data: Google Trends Analysis 18.5. Key Application Areas 18.6. Big Data in Microbiome Research 18.7. Big Data Services for Microbiome Research: List of Companies 18.8. Big Data Services for Microbiome Research: Profiles of Key Players 19. MICROBIOME THERAPEUTICS: MARKET FORECAST AND OPPORTUNITY ANALYSIS 19.1. Chapter Overview 19.2. Key Assumptions 19.3. Forecast Methodology 19.4. Global Microbiome Therapeutics Market, 2022-2035 19.5. Microbiome Therapeutics Market: Distribution by Leading Therapeutic Products, 2022-2035 20. MICROBIOME DIAGNOSTICS: MARKET FORECAST AND OPPORTUNITY ANALYSIS 20.1. Chapter Overview 20.2. Key Assumptions 20.3 Forecast Methodology 20.4. Global Microbiome Diagnostics Market, 2022-2035 20.5. Microbiome Diagnostics Market: Distribution by Target Indication, 2022-2035 20.6. Microbiome Diagnostics Market: Distribution by Therapeutic Area, 2022-2035 20.7. Microbiome Diagnostics Market: Distribution by Supply Channel, 2022-2035 20.8. Microbiome Diagnostics Market: Distribution by Key Geographical Regions, 2022-2035 21. FECAL MICROBIOTA THERAPIES: MARKET FORECAST AND OPPORTUNITY ANALYSIS 21.1. Chapter Overview 21.2. Key Assumptions 21.3. Forecast Methodology 21.4. Overall FMT Market, 2022-2035 21.5. Overall Microbiome Market by Product Offerings, 2022-2035 22. CASE STUDY: MICROBIOME-BASED PRODUCTS IN NON-PHARMACEUTICAL INDUSTRIES 22.1. Chapter Overview 22.2. List of Microbiome Products in Non-Pharmaceutical Industry 22.3. Applications of Microbiome Based Products in Agriculture Industry 22.4. Future Perspectives 23. CONCLUDING REMARKS 24. EXECUTIVE INSIGHTS 24.1 Chapter Overview 24.2. Rebiotix 24.3. S-Biomedic 24.4. Pendulum Therpaeutics 24.5. Siolta Therapeutics 24.6. Finch Therapeutics 24.7 Flame Biociences 24.8. List Biological Laboratories 24.9. Metabiomics 24.10. Scioto Biosciences 24.11. Stealth Startup 24.12. BiomX 24.13. Da Volterra 24.14. Chung Mei Pharmaceutical 24.15. Pacific Northwest National Laboratories 24.16. Quorum Innovations 24.17. 4D Pharma 25. APPENDIX I: TABULATED DATA 26. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets

小分子药物合作

100 项与 Lyophilised Oxalobacter formigenes(OxThera AB) 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
原发性高草酸尿症	临床3期	美国	OxThera AB	2007-10-01

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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


NCT02000219 (CTgov)	临床2期	原发性高草酸尿症	12	Oxalobacter formigenes	顧鑰構壓糧製積夢製廠(範餘網製鏇窪遞襯範觸) = 壓醖繭繭簾糧齋鹹鹽齋淵衊壓糧醖積製鏇構積 (鬱糧鑰獵襯餘廠淵鹽淵, 觸鏇蓋憲糧憲鑰鹹鬱襯 ~ 鹽蓋鏇蓋遞積壓鏇範鹹) 更多	-	2021-12-09
ASN2018	临床2期	原发性高草酸尿症1型	12	OC5	(簾艱壓鹹簾衊夢積鑰積) = Six subjects reported 52 adverse events; most were mild or moderate (88.5%) and not related (90.4%) to treatment. Two subjects experienced serious adverse events, unrelated to treatment. 積憲構餘壓鹹範構餘糧 (顧艱窪醖顧積簾鏇鬱襯 )	积极	2018-10-23