This is a phase I/II, open-label, study of twice-daily oral ladarixin with sotorasib in participants with advanced KRASG12C mutant non-small cell lung cancer (NSCLC).

开始日期2023-08-01

申办/合作机构

NYU Langone Health

EUCTR2022-000743-68-IT / Not yet recruiting临床2期

A phase II randomized, placebo-controlled, double-blinded, 2-parallel arm, clinical trial evaluating Ladarixin 400 mg twice a day as adjunctive therapy to improve glycemic control in overweight insulin-resistant patients with type 1 diabetes. - N/A

开始日期2022-12-13

申办/合作机构-

100 项与 Ladarixin Sodium 相关的临床结果

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100 项与 Ladarixin Sodium 相关的转化医学

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100 项与 Ladarixin Sodium 相关的专利（医药）

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项与 Ladarixin Sodium 相关的文献（医药）

2023-07-20·Diabetes/metabolism research and reviews

The therapeutic potential of an allosteric non-competitive CXCR1/2 antagonist for diabetic nephropathy.

Article

作者: Chiara Grasselli ; Silvia Bombelli ; Vittoria D'Esposito ; Michele Francesco Di Tolla ; Vincenzo L'Imperio ; Francesca Rocchio ; Martina Sara Miscione ; Pietro Formisano ; Fabio Pagni ; Rubina Novelli ; Pier Adelchi Ruffini ; Andrea Aramini ; Marcello Allegretti ; Roberto Perego ; Lidia De Filippis

AIMS:

Diabetic nephropathy is a major consequence of inflammation developing in type 1 diabetes, with interleukin-8 (IL-8)-CXCR1/2 axis playing a key role in kidney disease progression. In this study, we investigated the therapeutic potential of a CXCR1/2 non-competitive allosteric antagonist (Ladarixin) in preventing high glucose-mediated injury in human podocytes and epithelial cells differentiated from renal stem/progenitor cells (RSC) cultured as nephrospheres.

MATERIALS AND METHODS:

We used human RSCs cultured as nephrospheres through a sphere-forming functional assay to investigate hyperglycemia-mediated effects on IL-8 signalling in human podocytes and tubular epithelial cells.

RESULTS:

High glucose impairs RSC self-renewal, induces an increase in IL-8 transcript expression and protein secretion and induces DNA damage in RSC-differentiated podocytes, while exerting no effect on RSC-differentiated epithelial cells. Accordingly, the supernatant from epithelial cells or podocytes cultured in high glucose was able to differentially activate leucocyte-mediated secretion of pro-inflammatory cytokines, suggesting that the crosstalk between immune and non-immune cells may be involved in disease progression in vivo.

CONCLUSIONS:

Treatment with Ladarixin during RSC differentiation prevented high glucose-mediated effects on podocytes and modulated either podocyte or epithelial cell-dependent leucocyte secretion of pro-inflammatory cytokines, suggesting CXCR1/2 antagonists as possible pharmacological approaches for the treatment of diabetic nephropathy.

2023-01-01·Frontiers in endocrinology

Post hoc analysis of a randomized, double-blind, prospective trial evaluating a CXCR1/2 inhibitor in new-onset type 1 diabetes: endo-metabolic features at baseline identify a subgroup of responders.

Article

作者: Valeria Sordi ; Paolo Monti ; Vito Lampasona ; Raffaella Melzi ; Silvia Pellegrini ; Bart Keymeulen ; Pieter Gillard ; Thomas Linn ; Emanuele Bosi ; Ludger Rose ; Paolo Pozzilli ; Francesco Giorgino ; Efisio Cossu ; Lorenzo Piemonti

Aim:

In a recent randomized, multicenter trial (NCT02814838) a short-term anti-inflammatory treatment with ladarixin (LDX; an inhibitor of the CXCR1/2 chemokine receptors) did not show benefit on preserving residual beta cell function in new-onset type 1 diabetes. We present a post hoc analysis of trial patients in the predefined subgroup analysis developed according to baseline daily insulin requirement (DIR) tertiles.

Method:

A double-blind, randomized (2:1), placebo-controlled study was conducted in 45 men and 31 women (aged 18-46 years) within 100 days of the first insulin administration. Patients received LDX (400 mg twice daily) for three cycles of 14 days on/14 days off, or placebo. The primary endpoint was the area under the curve for C-peptide [AUC (0-120 min)] in response to a 2-h mixed meal tolerance test (MMTT) at week 13 ± 1. Seventy-five patients completed the week 13 MMTT and were divided into three groups according to the DIR tertiles: lower, ≤ 0.23U/kg/die (n = 25); middle, 0.24-0.40 U/kg/die (n = 24); upper, ≥ 0.41 U/kg/die (n = 26).

Results:

When considering the patients in the upper tertile (HIGH-DIR), C-peptide AUC (0-120 min) at 13 weeks was higher in the LDX group (n = 16) than in the placebo (n = 10) group [difference: 0.72 nmol/L (95% CI 0.9-1.34), p = 0.027]. This difference reduced over time (0.71 nmol/L at 26 weeks, p = 0.04; 0.42 nmol/L at 52 weeks, p = 0.29), while it has never been significant at any time in patients in the lower and/or middle tertile (LOW-DIR). We characterized at baseline the HIGH-DIR and found that endo-metabolic (HOMA-B, adiponectin, and glucagon-to-C-peptide ratio) and immunologic (chemokine (C-C motif) ligand 2 (CCL2)/monocyte chemoattractant protein 1 (MCP1) and Vascular Endothelial Growth Factor (VEGF)) features distinguished this group from LOW-DIR.

Conclusion:

While LDX did not prevent the progressive loss of beta-cell function in the majority of treated subjects, the post hoc analysis suggests that it could work in subjects with HIGH-DIR at baseline. As we found differences in endo-metabolic and immunologic parameters within this subgroup, this generates the hypothesis that the interactions between host factors and drug action can contribute to its efficacy. Further research is needed to evaluate this hypothesis.

2022-12-19·Toxicology

Stress-related testicular changes in Wistar and Sprague-Dawley rats following oral administration of an interleukin-8 inhibitor.

Article

作者: Virgilio Pace ; Franca Cattani

We describe testicular changes in Wistar and Sprague-Dawley rats following oral administration of DF2156A, a novel allosteric inhibitor of the CXCR1/CXCR2 receptors of interleukin-8. These testicular changes, which were associated with clinical signs, modifications of body weight parameters (decrease of body weight and weight gain) and a decrease of testosterone serum levels, were not considered to be a direct toxic effect of the test substance but secondary to a likely induced stress resulting from the oral administration of a high dose (200 mg/kg/day) of the test substance to male rats for a period of six weeks. Testicular changes consisted of seminiferous tubules atrophy and germinal cell degeneration and only occurred in animals presenting clinical signs of transient visible weight loss, ruffled fur and/or weakened condition, and/or decreased body weight and weight gain. A decrease in serum testosterone levels was only observed in those Sprague-Dawley rats affected by decreased body weight, weight gain and testicular changes. Only a single Wistar rat with testicular changes exhibited relevant reduced levels of circulating testosterone. Sperm analysis in terms of motility, morphology and number of sperm cells was altered in males presenting with morphological changes in the testes. Sprague-Dawley rats with testicular changes were more numerous and with more pronounced lesions than were Wistar rats.

项与 Ladarixin Sodium 相关的新闻（医药）

2023-07-11

·PRNewswire

Less than half of endocrinologists are impressed with Tzield's ability to delay T1D (MARKETVUE® REPORT)

Sanofi/formerly Provention's Tzield (teplizumab), a CD3 mAb, is the only FDA-approved disease-modifying therapy that delays progression of Stage 2 T1D in patients 8 years and older. However, less than half of U.S. clinicians are impressed with the drug's ability to delay T1D onset, according to findings from REACH Market Research. NEWTON, Mass., July 11, 2023 /PRNewswire/ -- Type 1 Diabetes (T1D) is a life-long autoimmune disease where the immune system destroys the insulin-producing islet cells in the pancreas until they no longer produce insulin. To date, insulin replacement therapy has been the backbone of T1D treatment but has a significant treatment burden on patients. Recently, clinical development appears to be shifting towards therapies that could delay the need for insulin and preserve beta cell function. To access REACH's MarketVue® Report on Type 1 Diabetes, visit or contact us at [email protected]. The launch of Tzield is an important milestone in T1D disease management in that patients in the pre-diabetic stage now have an option to delay T1D onset by ~2 years, thereby delaying insulin use. Further, the approval has increased interest and awareness around screening patients who may be at risk for the disease. While the approval of Tzield has created excitement amongst clinicians, the response to its efficacy and dosing is underwhelming; less than 30% of interviewed doctors reported that they found the dosing impressive, according to REACH Market Research 's MarketVue® assessment. Endocrinologist, U.S.: "What are the potential benefits of a drug like teplizumab in a person who has stage 2 diabetes? It is not a magical bullet, but it's a good start." The current T1D pipeline consists largely of insulin-based treatments with few therapies in development to delay T1D and insulin use in recent-onset patients, including: Sanofi's teplizumab label extension for patients 0-7 yrs and recent-onset T1D NIDDK's anti-thymocyte globulin and granulocyte colony-stimulating factor Diamyd Medical AB's Diamyd, an anti-IL5 mAb Dompe Farmaceutici S.p.A's ladarixin, an anti-IL-8, CXCR1 and CXCR2 inhibitor Novartis' iscalimab, an anti-CD40 mAb Endocrinologists interviewed by REACH are eager for preventative treatments that offer a longer time to T1D progression and more convenient dosing than Tzield. Meghana Pandit, REACH Analyst: "Tzield as a concept is viewed favorably by physicians, however, there are concerns around its dosing, and efficacy profile which is reported as marginal." About MarketVue® MarketVue® reports are a rare disease focused, fresh alternative to traditionally long and outdated market research reports. MarketVue® reports cover rare disease epidemiology and key market dynamics based on research from key opinion leader interviews, physician surveys, and secondary data. About REACH Market Research REACH is an independent pharmaceutical market research company focused on rare and niche diseases. With decades of experience in pharmaceutical market research and life sciences consulting, REACH fills an important gap in the market – accessible market research solutions for rare and niche diseases. SOURCE REACH Market Research

上市批准

2023-03-02

·PRNewswire

DelveInsight Evaluates a Robust Diabetes Pipeline as 200+ Influential Pharma Players to Set Foot in the Domain

The prevalence of diabetes has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Diabetes and the growing research and development activities to develop novel therapies to treat diabetes to drive the market. The companies developing the potential therapies in the last stage of development include Eli Lilly and Company, Daewoong Pharmaceutical, Janssen Biotech, and several others. LAS VEGAS, March 2, 2023 /PRNewswire/ -- DelveInsight's ' Diabetes Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline diabetes therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the diabetes pipeline domain. Key Takeaways from the Diabetes Pipeline Report DelveInsight's diabetes pipeline report depicts a robust space with 200+ active players working to develop 200+ pipeline therapies for diabetes treatment. Key diabetes companies such as Daewoong Pharmaceutical, Janssen Biotech, Zealand Pharma, BioRestorative Therapies, Elevian, Oramed Pharmaceuticals, ImCyse, Novo Nordisk, Enthera, Precigen, Inc., Japan Tobacco, Avotres, AstraZeneca, Landos Biopharma, Vertex Pharmaceuticals, REMD Biotherapeutics, Inc., Eledon Pharmaceuticals, Eli Lilly and Company, Novo Nordisk A/S, Diamyd Medical, NextCell Pharma, ViaCyte, Op-T LLC, Dompé Farmaceutici S.p.A, ILTOO Pharma, Throne Biotechnologies, Oramed Pharmaceuticals, Janssen Research & Development, LLC, Jaguar Gene Therapy, SQZ Biotechnologies, Genprex, Inc., CRISPR Therapeutics, Biora Therapeutics, Genprex, Inc., and others are evaluating new diabetes drugs to improve the treatment landscape. Promising diabetes pipeline therapies in various stages of development include Enavogliflozin, Golimumab, Dasiglucagon, ThermoStem, rGDF11, IMCY-0098, Insulin icodec, CagriSema, FDC Sema-OW GIP, SemaDapa FDC, ENT-001, AG019, JTT-662, AVT-001, AZD-0186, Cotadutide, LABP-111, VX-880, Encapsulated islet cell program, CPP-1X-T, REMD-477, AT-1501, LY 3209590, Orforglipron, LY3437943, Mazdutide, Peptide YY analogue agonist, GIPR agonist long acting, GIPR Agonist Long Acting II, LY 3493269, NNC0363-0845, Diamyd, ProTrans, VC-02, OPT101, Ladarixin, ILT-101, Stem Cell Educator Therapy, ORMD-0801, Golimumab, JAG301, SQZ TAC research program, VCTX 211, and others. In February 2023, Genprex, Inc. announced that data highlighting the potential of its gene therapy for Type 1 diabetes was being presented by its research collaborators at the University of Pittsburgh at the four-day International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2023).These results were compelling as they demonstrated the potential for this gene therapy to create newly formed beta-like cells that can produce insulin. They also validated earlier studies of this approach in diabetic mouse models that showed restoration of normal blood glucose levels for several months. In February 2023, Provention Bio, Inc. announced the closing of the $35 million equity investment from Sanofi US under the previously announced Co-Promotion Agreement and Securities Purchase Agreement (the "Purchase Agreement").Pursuant to the Purchase Agreement, Sanofi purchased 2,712,497 shares of the Company's common stock, par value $0.0001 per share, at a price of $12.90 per share, representing a total investment of $35 million. In January 2023, iTolerance, Inc. announced it has entered into a Master Services Agreement (MSA) with the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine, for the advancement of its novel iTOL-100 platform technology as a potential cure for Type 1 Diabetes. In November 2022, Biocon Limited announced the signing of a semi-exclusive partnership agreement with Zentiva, a leading pharmaceutical company in Europe, for the commercialization of its vertically integrated, complex formulation, Liraglutide, a drug-device combination for the treatment and management of Type 2 diabetes and obesity.Under the terms of this agreement, Biocon is responsible for the manufacturing and supply of Liraglutide to Zentiva for its commercialization across 30 countries in Europe. Biocon also retained the right to commercialize this product under its own brand in the region. In November 2022, The US Food and Drug Administration (FDA) approved Provention Bio's biologics license application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients. The anti-CD3-directed antibody Tzield aims to delay the onset of Stage 3 T1D in adults and children aged eight years and above who are currently with stage 2 T1D. Request a sample and discover the recent advances in diabetes drug treatment @ Diabetes Pipeline Report The diabetes pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage diabetes drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the diabetes clinical trial landscape. Diabetes Overview Diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin or when the body does not use the insulin that is produced effectively. The vast majority of diabetes can be divided into two types: type 1 and type 2. Diabetes symptoms include polyuria, polydipsia, weight loss, sometimes accompanied by polyphagia and blurred vision. Chronic hyperglycemia may also cause growth impairment and susceptibility to certain infections. Diabetes long-term complications include retinopathy, which can lead to vision loss, nephropathy, which can lead to renal failure, peripheral neuropathy, which can lead to foot ulcers, amputations, and Charcot joints, and autonomic neuropathy, which can cause gastrointestinal, genitourinary, and cardiovascular symptoms. Diabetes is diagnosed through a thorough physical examination, medical history, and a battery of specialized tests. The A1C, or glycated hemoglobin test, is the primary test used to diagnose both type 1 and type 2 diabetes. Diabetes treatment typically consists of diet control, exercise, home blood glucose testing, oral medication, and insulin. Insulin is the primary treatment for type 1 diabetes, and people with type 2 diabetes can be treated with oral medications but may need insulin in some cases. Find out more about drugs for diabetes @ New Diabetes Drugs A snapshot of the Diabetes Pipeline Drugs mentioned in the report: Learn more about the emerging diabetes pipeline therapies @ Diabetes Clinical Trials Diabetes Therapeutics Assessment The diabetes pipeline report proffers an integral view of diabetes emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Diabetes 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: Tumor necrosis factor alpha inhibitors, Glucagon receptor agonists, Cytotoxic T lymphocyte stimulants, Apoptosis inhibitors, Caspase inhibitors, Insulin-like growth factor binding protein inhibitors, Gene transference, Interleukin-10 expression modulators, CD40 antigen modulators Key Diabetes Companies: Daewoong Pharmaceutical, Janssen Biotech, Zealand Pharma, BioRestorative Therapies, Elevian, Oramed Pharmaceuticals, ImCyse, Novo Nordisk, Enthera, Precigen, Inc., Japan Tobacco, Avotres, AstraZeneca, Landos Biopharma, Vertex Pharmaceuticals, REMD Biotherapeutics, Inc., Eledon Pharmaceuticals, Eli Lilly and Company, Novo Nordisk A/S, Diamyd Medical, NextCell Pharma, ViaCyte, Op-T LLC, Dompé Farmaceutici S.p.A, ILTOO Pharma, Throne Biotechnologies, Oramed Pharmaceuticals, Janssen Research & Development, LLC, Jaguar Gene Therapy, SQZ Biotechnologies, Genprex, Inc., CRISPR Therapeutics, Biora Therapeutics, Genprex, Inc., and others. Key Diabetes Pipeline Therapies: Enavogliflozin, Golimumab, Dasiglucagon, ThermoStem, rGDF11, IMCY-0098, Insulin icodec, CagriSema, FDC Sema-OW GIP, SemaDapa FDC, ENT-001, AG019, JTT-662, AVT-001, AZD-0186, Cotadutide, LABP-111, VX-880, Encapsulated islet cell program, CPP-1X-T, REMD-477, AT-1501, LY 3209590, Orforglipron, LY3437943, Mazdutide, Peptide YY analogue agonist, GIPR agonist long acting, GIPR Agonist Long Acting II, LY 3493269, NNC0363-0845, Diamyd, ProTrans, VC-02, OPT101, Ladarixin, ILT-101, Stem Cell Educator Therapy, ORMD-0801, Golimumab, JAG301, SQZ TAC research program, VCTX 211 and others. Dive deep into rich insights for new drugs for diabetes treatment; visit @ Diabetes Medications Table of Contents For further information on the diabetes pipeline therapeutics, reach out @ Diabetes Drug Treatment Related Reports Type 1 Diabetes Market Type 1 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 1 diabetes companies, including Histogen , Novo Nordisk, Prevention Bio, among others. Type 1 Diabetes Epidemiology Forecast Type 1 Diabetes Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted type 1 diabetes epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Diabetes Market Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetes companies, including TikoMed, Avotres, REMD Biotherapeutics, Novo Nordisk, among others. Type 2 Diabetes Market Type 2 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 2 diabetes companies, including Sanofi, Eli Lilly and Company, AstraZeneca, Novartis, among others. Type 2 Diabetes Pipeline Type 2 Diabetes Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key type 2 diabetes companies, including Sanofi, Eli Lilly and Company, Novartis, 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

并购引进/卖出

2021-02-11

·药融圈

40款新药出现研发进展，3款新药重磅来袭！多款新药研发阶段发生改变，涉及罗氏、君实、礼来、兆科等！

▲速抢免费参会名额 | 大湾区(广州)生物医药创新者峰会导语根据公开资料不完全统计，药融云为大家检测到了2021年1月29日至2021年2月5日的全球新药重大研发进展40条。其中涉及药物提交上市申请3条，临床重大进展37条，其中有1条获得特殊审批途径。跨国药企在国际上大展拳脚，国产药企也不遑多让。君实生物研发的etesevimab获“紧急使用授权”资格，为治疗新冠添砖加瓦。君实生物的股票也节节升高。“国产之光”CT-707进入临床三期，我国原研抗肿瘤药再添一大助力。数据来源：药融云全球药物研发数据库据统计，40款药物的治疗领域主要是肿瘤、神经系统、感染等。生物药生物药中nemolizumab提交上市申请； Etesevimab公布3期临床试验结果； 01 nemolizumab（奈莫利珠单抗）近日，罗氏研发（Galderma SA和Maruho Co Ltd合作研发）的nemolizumab提交上市申请，nemolizumab是一种抗白细胞介素31受体（IL-31R）的人源化单克隆抗体，用于治疗特应性皮炎、结节性痒疹，曾获“突破性疗法”资格认定。Nemolizumab可通过竞争性地阻断IL-31与其受体的结合来抑制IL-31的生物活性，阻断IL-31信号传导。IL-31是一种诱导瘙痒的细胞因子，其信号传导在结节性痒疹发病机制中起着关键作用。 Nemolizumab的III期临床试验共入组了215例日本13岁以上的中度至重度瘙痒患者，根据基线瘙痒视觉模拟量表(VAS)评分中位数为75.4分。研究中，患者以2:1的比例随机分配，接受每4周一次皮下注射nemolizumab或安慰剂治疗直至第16周（nemolizumab组，n=143；安慰剂组，n=72；）。该研究中，患者同时使用局部抗炎药。 02 etesevimab 2020年11月礼来递交Bamlanivimab+etesevimab联合治疗新型肺炎冠状病毒感染(COVID-19)的“紧急使用授权”申请，近日此申请获批。君实生物研发（礼来合作研发）的etesevimab是一种抑制COVID19刺突糖蛋白的人源化单克隆抗体，用于治疗新型肺炎冠状病毒感染(COVID-19)和病毒性肺炎。Etesevimab能特异性结合SARS-CoV-2表面刺突蛋白受体结构域，并能有效阻断病毒与宿主细胞表面ACE2受体的结合。将点突变引入人类IgG1抗体以减轻效应。 2020年5月4日，礼来与君实生物达成合作协议，以1000万美元预付款+2.44亿美元里程碑金额获得etesevimab大中华区外的全球权益。 2021年1月26日，礼来宣布，BLAZE-1研究的III期临床试验达到主要研究终点，Bamlanivimab 2800mg 和Etesevimab 2800mg联合治疗显著降低了近期被确诊为新型肺炎冠状病毒感染(COVID-19)高风险患者COVID-19相关住院和死亡事件（下称：“事件”）。在1035名患者中，双抗体联合治疗组事件发生率为2.1%（11例），安慰剂组事件发生率为7.0% （36例），表明事件发生风险降低了70% (p=0.0004)。研究中共有10例死亡，均发生在安慰剂组，Bamlanivimab和Etesevimab双抗体联合治疗组中无死亡事件。 Bamlanivimab和Etesevimab双抗体联合治疗组在所有关键次要终点方面也显示出统计学显著改善，为该疗法可降低病毒载量并加速症状缓解提供了有力的证据。 03 COVAC-2 萨斯喀彻温大学研发的治疗新型肺炎冠状病毒感染(COVID-19)的COVAC-2。 04 BIVV-020 赛诺菲研发的BIVV-020是一种补体C1s抑制剂，用于治疗慢性炎性脱髓鞘性多发性神经根神经病、冷凝集素病、血小板减少症。 2020年12月16日，赛诺菲向NMPA递交1类进口治疗用生物制品BIVV-020注射液的临床申请。 05 REGN-5668 再生元研发的双特异性抗体REGN-5668是一种黏蛋白16调节剂和T-细胞表面糖蛋白CD28刺激剂，用于治疗输卵管癌、转移性卵巢癌和腹膜肿瘤。 06 MT-1002 陕西麦科奥特科技有限公司研发的MT-1002是凝血因子IIa和糖蛋白IIb/IIIa拮抗剂，用于治疗急性冠状动脉综合征和血栓形成。 07 HB-201 HOOKIPA Pharma Inc研发的HB-201是一种人乳头瘤病毒E6和E7蛋白抑制剂，用于治疗腺癌、头颈部肿瘤、口腔肿瘤、咽喉部肿瘤、鳞状细胞癌和子宫颈癌。小分子治疗药小分子治疗药中阿达帕林+盐酸克林霉素、二甲亚砜提交上市申请； Ladarixin和CT-707进入临床三期； 01 阿达帕林+盐酸克林霉素李氏大药厂研发的维甲酸受体激动剂adapalene + clindamycin hydrochloride（阿达帕林+盐酸克林霉素）用于治疗痤疮。李氏大药厂的综合性基地之一兆科（广州）眼科药物有限公司于2021年2月2日向NMPA递交上市申请。阿达帕林盐酸克林霉素复方凝胶的关键Ⅲ期临床试验的主要数据表明，该研究已达到主要终点指标，证明阿达帕林盐酸克林霉素复方凝胶优于单独使用阿达帕林凝胶或克林霉素凝胶，具有高度统计差异（P<0.0001）。阿达帕林盐酸克林霉素复方凝胶的Ⅲ期多中心、随机、单盲、平行、阳性对照研究（NCT03615768）旨在评估阿达帕林盐酸克林霉素复方凝胶治疗中度寻常型痤疮的疗效性和安全性。先前Ⅱ期临床研究结果表明，0.1% 阿达帕林+1%克林霉素是治疗寻常型痤疮的最佳组合，并在Ⅲ期临床研究中用作实验组。该复方凝胶通过结合使用两种具有不同作用机理的药物及增加克林霉素的吸收来产生协同效应，从而减少使用抗生素以避免产生细菌耐药性。 02 二甲亚砜杏林制药研发的dimethyl sulfoxide（二甲亚砜）用于治疗间质性膀胱炎，获“孤儿药”资格认定。 03 ladarixin Dompe Group研发的ladarixin是一种CXC趋化因子受体1和2、白介素8受体拮抗剂，用于治疗1型糖尿病，获得“儿科用药研究计划”。 Ladarixin的临床三期试验是一项随机、多中心、双盲、安慰剂试验，入组患者为有较低残余β细胞功能的青少年和成人新发1型糖尿病患者，主要目的是评估通过抑制CXCL-8（IL-8）的生物学活性来维持β细胞功能的有效性。目前，该试验在美国的临床试验点已启动患者招募，计划在2021年上半年开始研究。欧洲试验点的招募预计将持续到2022年。 ladarixin 的3期临床试验的启动遵循了2期临床试验（NCT02814838）的结果，在2期临床研究中，两个研究组之间未检测到临床相关的安全性观察结果。此外，在2期临床研究中，抑制CXCL-8（IL-8）的新方法，在新发1型糖尿病患者中显示出保存胰腺β细胞和延缓疾病进展的良好效果。研究中，ladarixin的耐受性良好。 04 CT-707 北京赛林泰研发的CT-707是一种间变性淋巴瘤激酶受体和黏着斑激酶2抑制剂，用于治疗非小细胞肺癌。CT-707是我国自主研发、具有完全只是产权的1类创新药，是全新结构的二代ALK抑制剂。结语辞旧迎新跨年前后，多款药物提交上市申请和进入临床三期，不泛有国产原研新药。随着国产创新企业在资本、政策的推动下迅速崛起，国产药企融入世界，我国成为新药主流市场亦不远矣。版权声明：本文转自药融云，如不希望被转载的媒体或个人可与我们联系，我们将立即删除【关于药融圈】药融圈围绕我国生物医药产业链，针对生物医药大数据、技术和资本投资、药融园(产业园)等开展系列系统性工作，促进我国生物医药产业健康发展，完善产业链，共同面对全球合作和竞争。点分享点点赞点在看

抗体合作孤儿药特殊审批突破性疗法

100 项与 Ladarixin Sodium 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16212

研发状态

适应症	最高研发状态	国家/地区	公司
1型糖尿病	临床3期	意大利更多	Dompe Farmaceutici SpA 更多
胰岛素抵抗	临床2期	意大利更多	Dompe Farmaceutici SpA 更多
大疱性类天疱疮	终止	意大利更多	Dompé Pharmaceutici Spa 更多
黑色素瘤	终止	意大利更多	Dompe Farmaceutici SpA 更多
脊髓损伤	终止	瑞士更多	Dompe Farmaceutici SpA 更多

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临床结果

适应症

分期

评价

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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


NCT02814838 (CTgov)	临床2期	1型糖尿病	76	Ladarixin (Ladarixin)	鑰簾網鬱蓋觸窪鹽築獵(淵範築繭憲鹽憲獵衊觸) = 醖鬱鏇遞廠夢鏇醖艱鹹構觸築襯廠積鑰積積壓 (鏇獵範壓餘簾簾製繭製, 壓醖鹽蓋觸範壓顧範衊 ~ 衊觸襯獵壓糧願蓋願糧) 更多	-	2021-01-12
				Placebo (Placebo)	鑰簾網鬱蓋觸窪鹽築獵(淵範築繭憲鹽憲獵衊觸) = 餘製鬱鹹積襯窪廠淵鹹構觸築襯廠積鑰積積壓 (鏇獵範壓餘簾簾製繭製, 膚顧壓鬱衊襯積獵淵糧 ~ 遞憲鏇廠膚鏇願積網齋) 更多
NCT02814838 (Pubmed)	临床2期	1型糖尿病 HOMA-B \| adiponectin \| glucagon-to-C-peptide ratio ... 更多	-	Ladarixin	繭積網憲鏇鑰鏇積繭餘(鑰鏇齋積鹹膚衊範繭築) = 衊網鏇鬱襯鹹築膚襯選觸窪憲鏇繭鏇築觸鹹廠 (觸廠艱蓋選鑰觸鏇選淵, 0.9 ~ 1.34)	-	2023-01-01
NCT02814838 (ADA2020)	临床2期	1型糖尿病	76	Ladarixin 400 mg BID	遞鬱願範夢壓獵齋構選(齋齋壓鹽鏇窪範憲夢選) = 選鑰構廠夢窪齋構簾願製襯鹽膚範衊範簾顧衊 (衊憲壓餘網積醖餘鹽艱 )	-	2020-06-01
				Placebo	遞鬱願範夢壓獵齋構選(齋齋壓鹽鏇窪範憲夢選) = 衊廠廠簾蓋遞衊壓顧壓製襯鹽膚範衊範簾顧衊 (衊憲壓餘網積醖餘鹽艱 )