A Pivotal Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving an Angiotensin II Receptor Blocker (ARB)

DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor that, when administered concurrently with an ARB, is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. The purpose of this pivotal randomized double-blind study is to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared with placebo over a treatment period of 104 weeks in adult patients with FSGS who are being treated with an ARB. Given the rarity of the disease and the similarities between adults and pediatric patients with FSGS, Dimerix will also investigate the efficacy and safety of DMX 200 in adolescents aged 12 to 17 years. The double-blind period will be followed by an open-label extension (OLE) which aims to assess the long-term efficacy and safety of DMX 200 for up to 2 additional years.

开始日期2022-05-30

申办/合作机构

Dimerix Bioscience Pty Ltd.

ACTRN12622000066785 / Recruiting临床3期

A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB)

开始日期2022-05-30

申办/合作机构

Dimerix Bioscience Pty Ltd.

100 项与厄贝沙坦/丙帕诺相关的临床结果

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100 项与厄贝沙坦/丙帕诺相关的转化医学

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100 项与厄贝沙坦/丙帕诺相关的专利（医药）

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项与厄贝沙坦/丙帕诺相关的文献（医药）

2024-10-01·BMJ Open

Combination of the chemokine receptor type 2 (CCR2) antagonist DMX-200 and candesartan for COVID-19: a randomised controlled trial

Article

作者: Jardine, Meg ; Pollock, Carol ; Rathore, Vinay ; Jones, Cheryl ; Fox, Gregory ; Bangi, Ashpak ; Snelling, Thomas L ; Bassi, Abhinav ; Jones, Mark ; Jain, Manish Kumar ; Kotwal, Sradha ; D'Cruz, Sanjay ; O'Hara, Daniel Vincent ; Faridah Syed Omar, Sharifah ; Totterdell, James ; Burrell, Louise ; Jha, Vivekanand ; Wilcox, Arlen

Objective:

To determine whether a chemokine receptor type 2 antagonist, DMX-200 (repagermanium), in combination with an angiotensin receptor blocker, candesartan, improves clinical outcomes in people with COVID-19.

Design:

Prospective, multicentre, double-blind, placebo-controlled trial.

Setting:

Ten acute care hospitals in India.

Participants:

Adults <65 years old intended for hospital admission with moderate/severe COVID-19 disease (respiratory rate ≥24 breaths per minute or oxygen saturation ≤93% on room air).

Intervention:

DMX-200 120 mg two times per day, or placebo, on background of titratable candesartan commencing at 4 mg two times per day, for 28 days.

Main outcome measures:

The primary endpoint was COVID-19 disease severity on a modified WHO Clinical Progression Scale (WHO scale) on day 14. Secondary outcomes included the WHO scale at days 28, 60, 90 and 180; intensive care unit (ICU) admission, respiratory failure or death within 28 days; length of hospitalisation; and requirement for ventilatory support or dialysis.

Results:

Between December 2021 and August 2022, 518 people were screened, with 49 randomised to DMX-200 or placebo on a background of candesartan. The study was terminated early due to recruitment barriers, including an external requirement to restrict enrolment to adults <65 years old, contributing to a 91% screen failure rate. The median WHO Clinical Progression Scale (WHO scale) score at day 14 for both groups was 1 (IQR 1–1), indicating most participants were discharged with no limitations on activities by this time. Formal comparison was not performed due to the small sample size. One participant receiving DMX-200 died of COVID-19 disease progression. No participants required ICU admission, ventilation or dialysis. Median length of hospitalisation in both groups was 6 days (IQR 6–7 days). WHO scale scores were similar at 28, 60, 90 and 180 days.

Conclusion:

Due to recruitment barriers, the study was unable to determine whether DMX-200 improves clinical outcomes in people with COVID-19.

Trial registration number:

ClinicalTrials.govNCT05122182.

2023-04-11·JAMA

Effect of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Initiation on Organ Support–Free Days in Patients Hospitalized With COVID-19

Article

IMPORTANCE:

Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19.

Objective:

To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19.

DESIGN, SETTING, AND PARTICIPANTS:

In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022).

INTERVENTIONS:

Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days.

MAIN OUTCOMES AND MEASURES:

The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes.

RESULTS:

On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively).

CONCLUSIONS AND RELEVANCE:

In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT02735707

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Investigation of Strategies to Block Downstream Effectors of AT1R-Mediated Signalling to Prevent Aneurysm Formation in Marfan Syndrome

Article

作者: Verstraeten, Aline ; Meester, Josephina ; Loeys, Bart ; Schippers, Jolien ; Van Kimmenade, Roland R. J. ; Danser, A. H. Jan ; Valdivia Callejon, Irene ; Peeters, Silke ; Buccioli, Lucia ; Luyckx, Ilse ; Bastianen, Jarl

Cardiovascular outcome in Marfan syndrome (MFS) patients most prominently depends on aortic aneurysm progression with subsequent aortic dissection. Angiotensin II receptor blockers (ARBs) prevent aneurysm formation in MFS mouse models. In patients, ARBs only slow down aortic dilation. Downstream signalling from the angiotensin II type 1 receptor (AT1R) is mediated by G proteins and β-arrestin recruitment. AT1R also interacts with the monocyte chemoattractant protein-1 (MCP-1) receptor, resulting in inflammation. In this study, we explore the targeting of β-arrestin signalling in MFS mice by administering TRV027. Furthermore, because high doses of the ARB losartan, which has been proven beneficial in MFS, cannot be achieved in humans, we investigate a potential additive effect by combining lower concentrations of losartan (25 mg/kg/day and 5 mg/kg/day) with barbadin, a β-arrestin blocker, and DMX20, a C-C chemokine receptor type 2 (CCR2) blocker. A high dose of losartan (50 mg/kg/day) slowed down aneurysm progression compared to untreated MFS mice (1.73 ± 0.12 vs. 1.96 ± 0.08 mm, p = 0.0033). TRV027, the combination of barbadin with losartan (25 mg/kg/day), and DMX-200 (90 mg/kg/day) with a low dose of losartan (5 mg/kg/day) did not show a significant beneficial effect. Our results confirm that while losartan effectively halts aneurysm formation in Fbn1C1041G/+ MFS mice, neither TRV027 alone nor any of the other compounds combined with lower doses of losartan demonstrate a notable impact on aneurysm advancement. It appears that complete blockade of AT1R function, achieved by administrating a high dosage of losartan, may be necessary for inhibiting aneurysm progression in MFS.

项与厄贝沙坦/丙帕诺相关的新闻（医药）

2023-03-30

·PRNewswire

Extremely Robust Acute Respiratory Distress Syndrome Pipeline Featuring 100+ Companies Expected to Change the Pace of the ARDS Treatment | DelveInsight

The rise in the incidence of ARDS stimulates the research and development of the drug, as it is likely to provide an appropriate environment for newer products to be profitable. Companies across the globe have shifted their focus toward the treatment of ARDS. The increase in the incidence will potentiate the treatment market for ARDS. Treatment goals, such as "permissive atelectasis", "permissive hypercapnia", and even "permissive hypoxemia", have been introduced as targets of ventilatory support. Together with the increased knowledge and understanding of how mechanical ventilation can harm the lungs, a major effort has been put into preventing or shortening the use of mechanical ventilation as much as possible and using settings that are considered to be "lung-protective." Several other supportive care options are available, but they all do not withstand the current needs of patients for this indication. LAS VEGAS, March 30, 2023 /PRNewswire/ -- DelveInsight's ' Acute Respiratory Distress Syndrome Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline acute respiratory distress syndrome therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the acute respiratory distress syndrome pipeline domain. Key Takeaways from the Acute Respiratory Distress Syndrome Pipeline Report DelveInsight's acute respiratory distress syndrome pipeline report depicts a robust space with 100+ active players working to develop 105+ pipeline therapies for acute respiratory distress syndrome treatment. Key acute respiratory distress syndrome companies such as Biocon, NRx Pharmaceuticals, Humanigen, Mesoblast, Sage Therapeutics, Evgen Pharma, Dimerix Bioscience, Vanda Pharmaceuticals, EUSA Pharma, Veru Healthcare, Foresee Pharmaceuticals, BioMarck Pharmaceuticals, Boehringer Ingelheim, Biohaven Pharmaceuticals, Biophytis, NovImmune SA, Constant Therapeutics, Windtree Therapeutics, Acticor Biotech, Direct Biologics, F4 Pharma, Apeiron Biologics, Trevena, Synact Pharma, Pluristem Therapeutics, UCB Pharma, Chiesi Farmaceutici, and others are evaluating new acute respiratory distress syndrome drugs to improve the treatment landscape. Promising acute respiratory distress syndrome pipeline therapies in various stages of development include Itolizumab, ZYESAMI, Lenzilumab, Remestemcel-L, Brexanolone, SFX-01, DMX-200, Tradipitant, Siltuximab, VERU 111, BIO 11006, FP025, Alteplase, Sarconeos Zavegepant, EB 05, USB 002, Sinapultide, Glenzocimab, DB 001, FX06, APN01, TRV 027, AP1189, PLX PAD, Zilucoplan, CHF5633, and others. In March 2023, Tetra Bio-Pharma received up to $150,000 in funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to support a research and development project to enable the development of its ARDS-003 oral formulation. Specifically, the funds will be used to optimize the formulation and perform animal non-GLP Pharmacokinetic Studies. In February 2021, Avid Bioservices and Humanigen announced that they had entered into a manufacturing services agreement to expand production capacity for lenzilumab. Under the terms of this Current Good Manufacturing Practice (cGMP) agreement, Avid would initiate technical transfer and analytical validation activities for lenzilumab with the goal of delivering cGMP drug substance batches to support Humanigen's regulatory and potential commercial activities. Request a sample and discover the recent advances in ARDS drug treatment @ Acute Respiratory Distress Syndrome Pipeline Report The acute respiratory distress syndrome pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage acute respiratory distress syndrome drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the acute respiratory distress syndrome clinical trial landscape. Acute Respiratory Distress Syndrome Overview Acute respiratory distress syndrome (ARDS) is a rapidly progressing condition that primarily affects the critically ill. The most serious complication of ARDS is fluid leaking into the lungs, making breathing difficult or impossible. The ARDS causes are classified as direct or indirect lung injuries. Direct lung injuries include pneumonia, aspiration, trauma, and others. Examples of indirect lung injuries include pancreatic inflammation, severe infection (also known as sepsis), blood transfusions, burns, and pharmaceutical responses. ARDS symptoms include shortness of breath, coughing, and fever; in some cases, high heart rates and rapid breathing have also been observed. Patients with ARDS may experience chest pain, especially during inhalation, and some may develop blue nails and lips due to drastically reduced oxygen levels in the blood. Mechanical ventilation, stress ulcer and venous thromboembolism prevention, nutritional support, and underlying damage therapy are all part of the acute respiratory distress syndrome treatment. Find out more about drugs for ARDS @ New Acute Respiratory Distress Syndrome Drugs A snapshot of the Acute Respiratory Distress Syndrome Pipeline Drugs mentioned in the report: Learn more about the emerging acute respiratory distress syndrome pipeline therapies @ ARDS Clinical Trials Acute Respiratory Distress Syndrome Therapeutics Assessment The acute respiratory distress syndrome pipeline report proffers an integral view of acute respiratory distress syndrome emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Acute Respiratory Distress Syndrome Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Androgen receptor antagonists, Hedgehog protein modulators, Histone deacetylase inhibitors, NF E2 related factor 2 stimulants, Wnt signalling pathway modulators, Cell replacements, Toll-like receptor 4 antagonists, Fibrinolytic agents, Plasminogen activator stimulants, Plasminogen activators, Myristoylated alanine-rich C kinase substrate inhibitors, Cell membrane permeability enhancers, Sodium channel agonists Key Acute Respiratory Distress Syndrome Companies: Biocon, NRx Pharmaceuticals, Humanigen, Mesoblast, Sage Therapeutics, Evgen Pharma, Dimerix Bioscience, Vanda Pharmaceuticals, EUSA Pharma, Veru Healthcare, Foresee Pharmaceuticals, BioMarck Pharmaceuticals, Boehringer Ingelheim, Biohaven Pharmaceuticals, Biophytis, NovImmune SA, Constant Therapeutics, Windtree Therapeutics, Acticor Biotech, Direct Biologics, F4 Pharma, Apeiron Biologics, Trevena, Synact Pharma, Pluristem Therapeutics, UCB Pharma, Chiesi Farmaceutici, and others. Key Acute Respiratory Distress Syndrome Pipeline Therapies: Itolizumab, ZYESAMI, Lenzilumab, Remestemcel-L, Brexanolone, SFX-01, DMX-200, Tradipitant, Siltuximab, VERU 111, BIO 11006, FP025, Alteplase, Sarconeos Zavegepant, EB 05, USB 002, Sinapultide, Glenzocimab, DB 001, FX06, APN01, TRV 027, AP1189, PLX PAD, Zilucoplan, CHF5633, and others. Dive deep into rich insights for new drugs for ARDS treatment; visit @ Acute Respiratory Distress Syndrome Medications Table of Contents For further information on the acute respiratory distress syndrome pipeline therapeutics, reach out @ Acute Respiratory Distress Syndrome Drug Treatment Related Reports Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key acute respiratory distress syndrome companies, including Cellular Biomedicine Group, Baylx, Histocell, Cartesian Therapeutics, Cynata Therapeutics, Immunovative Therapies, Orbsen Therapeutics, Celularity, Bonus BioGroup, Diffusion Pharmaceuticals, among others. Respiratory Distress Syndrome Market Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key respiratory distress syndrome companies, including Dimerix Bioscience, Vanda Pharmaceuticals, EUSA Pharma, Veru Inc., BioMarck Pharmaceuticals, CTI BioPharma, Athersys, Foresee Pharmaceuticals, Boehringer Ingelheim, among others. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key chronic obstructive pulmonary disease companies, including Sanofi, Chiesi Farmaceutici S.p.A., United Therapeutics Corporation, Verona Pharma, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

2023-03-05

·研发客

澳大利亚生物技术投融资研讨会，3月10日@上海&广州 | 会讯

2023年3月10日，澳大利亚贸易投资委员会（澳贸委）将于在上海和广州同期举办专项交流活动，介绍头部企业和研发管线，并寻求融资或合作。活动特邀澳大利亚驻华大使馆商务公使唐睿博（Rob Donelly）先生，介绍有关澳大利亚外商投资审核委员会（Foreign Investment Review Board, FIRB）的运行及投资并购澳大利亚生物医药行业的机会。澳贸委此次举办的专项交流活动，将携手澳大利亚生物技术协会（AusBiotech）、西澳大利亚州政府、维多利亚州政府等，一同增进便于中国生物技术同行和投资人对澳大利亚生命科学行业的了解。✦++上海站日期：2023年03月10日时间：9:45am–12:30pm （签到时间9:15）报名截止：2023年3月7日地点：上海市黄浦区中山南路505号老码头15号楼3楼留学墨尔本上海中心费用：非收费活动 (含交流午宴）请扫码完成参会注册。扫以下二维码注册参会：✦++广州站日期：2023年03月10日时间：上午9:30 –12:30 （签到时间9:00）报名截止：2023年3月7日地点：广州市黄浦区知识城国际合作交流中心一号楼三楼学术报告厅（黄埔创新大道与凤湖二路交叉口北侧227米）费用：非收费活动 (含交流午宴）请扫码完成参会注册。扫以下二维码注册参会：澳大利亚企业的信息（上下滑动查看）Argenica Therapeutics（上市公司）Dr Liz Dallimore, CEO 项目简介：ARG-007富含精氨酸的阳离子肽药物 – 为中风和其他急性中枢神经系统损伤后大脑提供保护。主要募集临床II期试验资金（缺血性中风）。Carina BiotechDr Deborah Rathjen, CEO项目简介: 用于治疗实体癌的嵌合抗原受体 T 细胞 (CAR-T) 疗法。为完成LGRCAR-T细胞疗法药物（晚期结直肠癌）临床I和II期试验及其它管线产品寻找投融资伙伴；寻找战略合作伙伴关系和合作，以进一步开发 Carina CAR 药物产品组合；CAR药物共同开发和对外许可证机会。Celosia TherapeuticsDr Brenton Hamdorf， CEO项目简介：神经退行性疾病的基因疗法药物 - ALS肌萎缩侧索硬化症治疗（也称为运动神经元病或卢伽雷氏病）；募集投融资完成临床前和开始临床I期试验。CerecinDr Charles Stacey, President & CEO 项目简介：中枢神经系统疾病代谢基础的药物和诊断方法。Cerecin专注于开发针对中枢神经系统疾病代谢基础的药物和诊断方法，是神经代谢领域的领导者。Cerecin的主要化合物药物CER-0001（一种酮类药物）靶向偏头痛和癫痫中存在的异常代谢途径。Dimerix（上市公司）Dr James Williams, Chairman 项目简介：炎症性疾病的候选药物项目，包括肾脏和呼吸系统疾病。Dimerix 的主要临床资产 DMX-200 药物正在进行 III 期试验，用于治疗 FSGS，一种罕见的肾脏疾病，以及对感染相关肺炎或糖尿病肾病患者的临床研究。此外，正在开发的DMX-700药物用于治疗慢性阻塞性肺疾病 (COPD)。 Emyria（上市公司）Dr Michael Winio, CEO项目简介：给药创新：Emyria 开发了一种超纯固体口服大麻素剂量平台（EMD-RX），解决了典型植物油制剂的许多局限性。EMD-RX 平台可支持多个药物注册机会。Emyria 的第一个剂型EMD-RX5处于III 期试验。新药开发：与西澳大利亚大学合作开发世界最大之一的MDMA 类化合物库。这些新的化学物质体积小、稳定、能穿透大脑并具有神经活性，因此有可能成为治疗一系列神经精神疾病的药物开展临床前研究。寻求有兴趣利用 Emyria超纯大麻素给药技术创造新剂型的制药公司；神经科学 CRO公司支持 MDMA药物发现计划；以及寻求生物科技投资者。Immuron（上市公司）Stephen Lydeamore, CEO项目简介: 具有口服活性的多克隆抗体药物。这些抗体可在胃肠道（“GI”）内进行靶向递送，并且不会进入血液。主要候选药物有可能改变现有的中度至重度弯曲杆菌病治疗模式。处于临床开发阶段的主要候选药物有可能改变现有的中度至重度弯曲杆菌病、艰难梭菌感染、产肠毒素大肠杆菌（ETEC）感染和旅行者腹泻（一种消化道疾病）的治疗模式。寻找合作伙伴1）扩大 Travelan®（旅行者腹泻）和 Protectyn®（肠道和肝脏健康）的地域销售 2）寻找IMM-529（艰难梭菌）药物开发/营销合作伙伴。Inoviq (上市公司)Dr Leearne Hinch, CEO项目简介：外泌体和精准诊断。用于研究目的EXO-NET® 泛外泌体捕获工具及其 hTERT 测试作为膀胱癌尿液细胞学测试的辅助手段。INOVIQ的诊断管道包括正在开发的血液测试，用于早期检测和监测卵巢、乳房和其他癌症。寻求潜在合作伙伴一起进行基于外泌体解决方案的研究、临床试验、诊断和治疗应用。Invion(上市公司)Thian Chew, CEO项目简介：Photosoft™ 技术领导者，用于治疗一系列癌症、动脉粥样硬化和传染病。持有Photosoft™技术所有癌症适应症在澳大利亚和新西兰的独家许可权和亚太地区（中国大陆除外）独家经销权。寻找战略合作伙伴来帮助推进 Photosoft™ 的发展，包括许可证合作机会。Orthocell (上市公司)Paul Anderson, CEO 项目简介：再生医学公司。国际领先技术 CelGro ™产品：一种增强骨骼、神经和肌腱损伤的胶原蛋白医疗设备，和 OrthoATI ™产品，一种世界领先的治疗慢性肌腱损伤的细胞疗法。Patrys（上市公司）Dr James Campbell, CEO项目简介：用于人类治疗应用的两种人源化脱氧单抗：PAT-DX1 （一种小抗体片段）和 PAT-DX3（一种全尺寸 IgG）。脱氧单抗有可能以三种不同的方式用于临床：1. 作为 DNA 修复系统中预先存在突变的癌症的独立疗法 2.与其他引起DNA损伤的药物联合使用，如化学疗法和放射疗法3. 作为传递有效载荷穿过血脑屏障或进入细胞核的试剂。Prescient Therapeutics（上市公司）Steven Yatomi-Clarke, CEO一家临床阶段肿瘤学公司，开发针对癌症的个性化医学方法，包括靶向疗法和细胞疗法项目简介：1）细胞疗法OmniCAR：是一种通用免疫受体平台，可通过单细胞产品实现可控的 T 细胞活性和多抗原靶向。OmniCAR 的模块化 CAR 系统将抗原识别与 T 细胞信号域分离。它是目前第一个允许将翻译后结合物共价加载到 T 细胞的通用免疫受体。2）靶向治疗PTX-100：一流的化合物，能够阻断一种重要的癌症生长酶，称为香叶基香叶基转移酶-1 (GGT-1)。PTX-100通过抑制癌细胞中 Rho、Rac 和 Ral 回路的激活来破坏致癌 Ras 通路，从而导致癌细胞凋亡（死亡）。PTX-100被认为是世界上唯一处于临床开发阶段的GGT-1抑制剂。Respirion PharmaceuticalsBrian Jones, CEO项目简介：专注于开发呼吸系统疾病的新疗法；主导产品是RSP-1502，一种吸入雾化治疗药物，可显着改善囊性纤维化（CF）患者慢性肺部感染的治疗。RSP-1502 是妥布霉素和金属螯合剂的新型组合，有可能在治疗 CF 患者铜绿假单胞菌肺部感染的护理标准中取代妥布霉素。Tessara TherapeuticsDr Christos Papadimitriou, CEO项目简介：Tessara开发了一个突破性的药物筛选平台，该平台具有一系列基于 RealBrain® 3D人类神经微组织的创新模型。该公司的商业模式涉及与跨国CRO机构和制药公司的技术许可和商业合作伙伴关系。VaxxasMike Junger, Senior Vice President项目简介：无针疫苗接种技术。Vaxxas 的疫苗贴片基于微阵列贴片 (MAP) 技术构建，专注于提高疫苗的效果和增加疫苗接种的可及性。凭借其专有的无针疫苗技术，Vaxxas 正在重新考虑疫苗接种（包括疫苗的分发和管理方式）以提高疫苗效力并增加全球范围内的可及性。Vaxxas 的疫苗贴片基于微阵列贴片 (MAP) 技术构建，替代传统针头和注射器疫苗接种方法。疫苗接种只需要把MAP短时间（约 10 秒）压在皮肤表面上即可（疫苗会进入皮表下面大量的免疫细胞），以达成疫苗接种效果。12个月内使用无针疫苗接种技术进行临床试验的疫苗有流感、麻疹和风疹以及 COVID-19。ASX Limited澳大利亚证券交易所James Posnett, General Manager, Listings澳大利亚生命科技企业上市机遇和挑战关于澳大利亚生命科学行业众所周知，澳大利亚是一个蓬勃发展的生命科学中心，研究出了很多全球性的创新成果，从冷冻胚胎试管婴儿技术和干细胞技术，到人工耳蜗和宫颈癌疫苗，澳大利亚凭借坚实的发展基础，被誉为“全球生物技术之都”，其生物医药领域一直处在全球领先地位。澳大利亚生物技术协会（AusBiotech）是澳大利亚的生命科学组织之一，致力于澳大利亚生命科学行业的发展、增长和繁荣。AusBiotech定期开展广泛的国际参与项目，包括中国、日本、韩国、新加坡、美国、新西兰等国家。2019年AusBiotech在香港和上海两地相继举办亚洲投资系列展览会，吸引共计200多位亚洲潜在投资者和合作伙伴出席展会。澳大利亚先进的生命科学研究一直着眼于欣欣向荣、生机蓬勃的亚洲市场。AusBiotech的成员开展了诸多前沿医学项目，比如再生医学。此项目包括基因治疗、细胞治疗和组织工程产品，旨在再生组织或替换受伤、患病或有缺陷的细胞、组织或器官，以恢复或建立功能和结构。其中细胞疗法是最广为人知的再生医学项目，特别是用干细胞移植来治疗血液、骨骼和免疫系统疾病，旨在将新的、健康的细胞引入病人的身体，以取代患病或缺失的细胞。此外，AusBioInvest作为澳大利亚生物技术年度活动的一部分，每年如期举行。该活动帮助澳大利亚生命科学公司与全球资本市场建立联系。去年10月， AusBioInvest 2022于西澳大利亚州的首府珀斯市举办，活动吸引了来自澳大利亚、美国、加拿大等国投资领域的大咖。投资者们纷纷表达了对澳大利亚生命科学企业的关注，以及如何创造机会促进全球临床医疗技术发展的想法。该年会主要合作伙伴珀斯市政府(The City of Perth)，在此次年会上也对西澳大利亚生命科学领域的创新者给予了大力支持。会议促进了生命科学领域的国际间合作以及全球发展。

细胞疗法基因疗法引进/卖出免疫疗法临床1期

2022-09-22

·PRNewswire

Despite Amplified Use of SGLT2 Inhibitors for Glomerular Diseases, EU and US Nephrologists Express a Continued Strong Desire for New Treatment Options for FSGS Patients, Spherix Reports

EXTON, PA., Sept. 21, 2022 /PRNewswire/ -- Focal segmental glomerulosclerosis (FSGS) is one of the leading causes of nephrotic syndrome across the world and is considered the most common glomerular cause of end-stage renal disease (ESRD).1 Spherix has been tracking the evolution of the FSGS market since 2018 to keep a pulse on how nephrologists are treating patients and the perceived potential for products as they make their way through development. Over the past few months, Spherix has released two reports revealing insights from both US-based and EU5-based nephrologists as a part of its Market Dynamix™: Focal Segmental Glomerulosclerosis (FSGS) research services. Insights were gathered from qualitative and quantitative research conducted with 100 nephrologists across the United States and more than 250 nephrologists from France, Germany, Italy, Spain, and the UK. These services provide insights into perceptions of unmet needs, gaps in care, and evolving treatment paradigms. Of note, Spherix experts found that while most FSGS patients are still confirmed via kidney biopsies, nephrologists are becoming increasingly likely to use genetic testing for diagnosis. As understanding of genetic causes of disease advances (including the role of APOL-1), nephrologists are optimistic for more targeted and effective therapies. Other findings of the US- and EU5-based research reveal that nephrologists across both geographies strongly agree that reducing proteinuria is an important treatment goal for their FSGS patients, as they believe proteinuria is a key contributor to FSGS progression. However, key regional differences emerge when nephrologists consider which proteinuria levels may trigger use of steroids, with some physicians much more aggressive and others more conservative. A major shift seen over the past year is the increasing use of SGLT2 inhibitors (including AstraZeneca's Farxiga/Forxiga, Boehringer Ingelheim/Lilly's Jardiance, and Janssen's Invokana) in glomerular disease patients. Nephrologists in the EU5 and the US are using these products more often in their FSGS and IgA nephropathy patients in particular, especially those with lingering proteinuria after initial ACE inhibitor and/or ARB treatment. In fact, reported use of SGLT2 inhibitors in primary FSGS patients more than doubled year-over-year in both regions captured in these studies, with expectations for continued growth. A growing number of nephrologists also indicate they will start patients on an ACEi/ARB alongside an SGLT2 inhibitor as they embrace this new mechanism of action. Despite the addition of SGLT2 inhibitors to the armamentarium, nephrologists across the EU5 and the US continue to rate FSGS patients overall as highly challenging to manage and believe there is an extremely high unmet need for new treatment options. To gauge pipeline product potential, Spherix assessed awareness, familiarity, desire to have approved, likelihood to prescribe, and estimated patient candidacy for the following assets: Abatacept (BMS) Atrasentan (Chinook) Bardoxolone methyl (Reata) Blesumab, ASKP1240 (Astellas/Kyowa Kirin) DMX-200 (Dimerix) GFB-887 (Goldfinch Bio) PF-06730512 (Pfizer) Sparsentan (Travere, commercialized by Vifor in the EU) VAR 200 (ZyVersa) VX-147 (Vertex) Spherix has in-depth expertise across the glomerular disease market (including FSGS, IgA nephropathy, Alport syndrome, C3G, membranous nephropathy, and more). The company has been a leader in tracking many of these markets for years, covering physician perspectives, treatment patterns, and pipeline assessments. This coverage includes in-depth interviews with key opinion leaders (KOLs) and "in-the-trenches" physicians. More research is also available through in-depth US-based chart audits as part of the RealWorld Dynamix™: FSGS (US) service. Additionally, Spherix will soon release its first IgA nephropathy study from the Japanese market. About Market Dynamix™ Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years, highlighting market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents. About RealWorld Dynamix™ RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the "why" behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns. About Spherix Global Insights Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets. All company, brand or product names in this document are trademarks of their respective holders.

100 项与厄贝沙坦/丙帕诺相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
局灶性节段性肾小球硬化症	临床3期	美国	Dimerix Bioscience Pty Ltd.	2022-05-30
局灶性节段性肾小球硬化症	临床3期	阿根廷	Dimerix Bioscience Pty Ltd.	2022-05-30
局灶性节段性肾小球硬化症	临床3期	澳大利亚	Dimerix Bioscience Pty Ltd.	2022-05-30
局灶性节段性肾小球硬化症	临床3期	巴西	Dimerix Bioscience Pty Ltd.	2022-05-30
局灶性节段性肾小球硬化症	临床3期	丹麦	Dimerix Bioscience Pty Ltd.	2022-05-30
局灶性节段性肾小球硬化症	临床3期	法国	Dimerix Bioscience Pty Ltd.	2022-05-30
局灶性节段性肾小球硬化症	临床3期	德国	Dimerix Bioscience Pty Ltd.	2022-05-30
局灶性节段性肾小球硬化症	临床3期	中国香港	Dimerix Bioscience Pty Ltd.	2022-05-30
局灶性节段性肾小球硬化症	临床3期	意大利	Dimerix Bioscience Pty Ltd.	2022-05-30
局灶性节段性肾小球硬化症	临床3期	马来西亚	Dimerix Bioscience Pty Ltd.	2022-05-30