A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase III Trial to Assess the Efficacy and Safety of Trimodulin (BT588) in Adult Hospitalized Subjects With Severe Community-acquired Pneumonia (sCAP)

The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV).
Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

开始日期2023-09-09

申办/合作机构

Biotest AG

CTIS2022-501352-28-00 / Recruiting

A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with severe community-acquired pneumonia (sCAP) - 996

开始日期2023-09-03

申办/合作机构

Biotest AG

NCT05531149 / Recruiting临床3期

A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase III Trial to Assess the Efficacy and Safety of Trimodulin (BT588) in Adult Hospitalized Subjects With CAP Including COVID-19 Pneumonia.

The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia.
Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.

开始日期2022-12-22

申办/合作机构

Biotest AG

100 项与 Trimodulin (Biotest) 相关的临床结果

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100 项与 Trimodulin (Biotest) 相关的转化医学

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100 项与 Trimodulin (Biotest) 相关的专利（医药）

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项与 Trimodulin (Biotest) 相关的文献（医药）

2023-09-01·Drugs in R&D

Biochemical Characterization of a New 10% IVIG Preparation [IgG Next Generation (BT595)/Yimmugo^®] Obtained from a Manufacturing Process Preserving IgA/IgM Potential of Human Plasma.

Article

作者: Hannappel, Achim ; Duellberg, Christian ; Maneg, Oliver ; Kistner, Steffen

BACKGROUND AND OBJECTIVE:

Human plasma is used for the generation of several life-saving drugs and contains valuable antibodies from the immunoglobulin classes IgG, IgM and IgA. Purified intravenous IgG solutions (IVIGs) form the majority of plasma-derived medicine to treat patients with various forms of immunodeficiencies. In conventional IVIG manufacturing processes, immunoglobulin classes IgM and IgA are often discarded as contaminants, but these antibody classes have been proven to be effective for the treatment of acute bacterial infections. Considering the increase in demand for human plasma-derived products and the ethical value of the raw material, a more resource-saving usage of human plasma is needed. Intensive research over the last decades showed that adverse reactions to IVIGs depend on the presence of thrombogenic factors, partially unfolded proteins, non-specific activation of the complement system, and blood group specific antibodies. Therefore, new IVIG preparations with reduced risks of adverse reactions are desirable.

METHOD:

A new manufacturing process that yields two biologics was established and quality attributes of the new IVIG solution (Yimmugo^®) obtained from this process are presented.

RESULTS:

Here, we provide a biochemical characterization of Yimmugo^®, a new 10% IVIG preparation. It is derived from human blood plasma by a combined manufacturing process, where IgM and IgA are retained for the production of a new biologic (trimodulin, currently under investigation in phase III clinical trials). Several improvements have been implemented in the manufacturing of Yimmugo^® to reduce the risk of adverse reactions. Gentle and efficient mixing by vibration (called "vibromixing") during a process step where proteins are at risk to aggregate was implemented to potentially minimize protein damage. In addition, a dedicated process step for the removal of the complement system activator properdin was implemented, which resulted in very low anticomplementary activity levels. The absence of measurable thrombogenic activity in combination with a very high degree of functional monomeric antibodies predict excellent efficacy and tolerability.

CONCLUSION:

Yimmugo^® constitutes a new high quality IVIG preparation derived from a novel manufacturing process that takes advantage of the full therapeutic immunoglobulin potential of human plasma.

2022-07-01·Thrombosis and haemostasis2区 · 医学

Polyvalent Immunoglobulin Preparations Inhibit Pneumolysin-Induced Platelet Destruction

2区 · 医学

Article

作者: Wolff, Martina ; Wesche, Jan ; Handtke, Stefan ; Palankar, Raghavendra ; Jahn, Kristin ; Greinacher, Andreas ; Wiebe, Friederike ; Hammerschmidt, Sven ; Schnarre, Annabel ; Weißmüller, Sabrina ; Schüttrumpf, Jörg ; Voß, Franziska

Platelets play an important role in the development and progression of respiratory distress. Functional platelets are known to seal inflammatory endothelial gaps and loss of platelet function has been shown to result in loss of integrity of pulmonary vessels. This leads to fluid accumulation in the pulmonary interstitium, eventually resulting in respiratory distress. Streptococcus pneumoniae is one of the major pathogens causing community-acquired pneumonia. Previously, we have shown that its major toxin pneumolysin forms pores in platelet membranes and renders them nonfunctional. In vitro, this process was inhibited by polyvalent intravenous immunoglobulins (IVIGs). In this study, we compared the efficacy of a standard IVIG preparation (IVIG, 98% immunoglobulin G [IgG]; Privigen, CSL Behring, United States) and an IgM/IgA-enriched immunoglobulin preparation (21% IgA, 23% IgM, 56% IgG; trimodulin, Biotest AG, Germany) to inhibit pneumolysin-induced platelet destruction. Platelet destruction and functionality were assessed by flow cytometry, intracellular calcium release, aggregometry, platelet viability, transwell, and flow chamber assays. Overall, both immunoglobulin preparations efficiently inhibited pneumolysin-induced platelet destruction. The capacity to antagonize pneumolysin mainly depended on the final IgG content. As both polyvalent immunoglobulin preparations efficiently prevent pneumolysin-induced platelet destruction and maintain platelet function in vitro, they represent promising candidates for clinical studies on supportive treatment of pneumococcal pneumonia to reduce progression of respiratory distress.

2019-08-01·Innate immunity4区 · 生物学

The novel polyclonal Ab preparation trimodulin attenuates ex vivo endotoxin-induced immune reactions in early hyperinflammation

4区 · 生物学

Article

作者: Bacher, Annica ; Sadeghi, Kambis ; Heinz, Corina ; de Martin, Angelika ; Sachet, Monika ; Baumann, Suzann ; Spittler, Andreas ; Duerr, Celia

Sepsis is a syndrome associated with excessive inflammation. Since mortality from sepsis remains high, more laboratory research is needed to provide insight into more effective ways to use novel, potentially more beneficial agents in sepsis. We investigated the ex vivo immunomodulatory effect of a novel polyclonal Ab preparation, trimodulin, containing IgM (∼23%), IgA (∼21%) and IgG (∼56%). Using whole blood and purified PBMCs from healthy volunteers and patients with sepsis, various ex vivo investigations upon endotoxin challenge and pre- and post-trimodulin treatment were performed. Endotoxin-induced TNF-α secretion was noticeably lower with than without trimodulin, implying attenuation of the hyper-responsive state. Trimodulin also lowered TLR2, TLR4, CD11b and CD64 detection on LPS/lipoteichoic acid-stimulated monocytes. These responses were observed in cells from healthy volunteers only shortly after ex vivo endotoxin stimulation and in whole blood from patients with early-stage sepsis. Furthermore, trimodulin markedly reduced lymphocyte proliferation and release of pro- and anti-inflammatory cytokines, but did not affect phagocytosis or oxidative-burst activities of endoxin-stimulated cells. Thus, trimodulin mitigated monocyte and lymphocyte hyperinflammatory responses early after endotoxin exposure. Determining whether early in vivo administration of trimodulin will elicit similar positive immunomodulatory effects and offer a clinical benefit warrants investigation.

项与 Trimodulin (Biotest) 相关的新闻（医药）

2024-07-01

·BioSpace

Grifols’ Biotest to achieve USD 1 billion in US sales of Yimmugo® over next seven years

Biotest, a Grifols Group company, is expected to launch its recently FDA-approved intravenous immunoglobulin in the U.S. in first quarter 2025 Yimmugo will be distributed by Kedrion in the U.S. as part of a broader Group channel strategy, with Grifols focusing on continued growth of its current portfolio for this market It adds to Grifols’ strong franchise of intravenous and subcutaneous immunoglobulins to meet growing patient demand for these therapeutics Yimmugo will be followed by other proteins in the pipeline, including fibrinogen and trimodulin, both in late-stage development BARCELONA, Spain, July 01, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), one of the world’s leading producers of plasma-derived medicines, today announced that Biotest, a Grifols Group company, forecasts approximately USD 1 billion in revenue from sales in the United States of its intravenous immunoglobulin (Ig) Yimmugo® during the next seven years, following recent Food and Drug Administration (FDA) approval to treat primary immunodeficiencies (PID). Yimmugo is the first Biotest medicine to be commercialized in the U.S. from its new FDA-certified “Next Level” production facility in Dreieich, Germany, which is already approved for production and marketing in Europe, where Yimmugo has been commercialized since late 2022. It will launch in the U.S. in the first quarter of 2025 and be distributed by Kedrion under a seven-year agreement with Biotest, part of an overarching Grifols Group channel strategy to ensure extensive reach and availability of its Ig therapeutics. Grifols Group and Kedrion have a longstanding collaborative relationship. Grifols itself will focus on continuing the growth of its leading and well-established intravenous and subcutaneous Ig treatments. Now, with Yimmugo, the Group’s U.S. portfolio will have an additional option to address the growing demand for Ig to treat immunodeficiencies, in which part of the body’s immune system is missing or does not function properly, and other medical conditions. “Ensuring that patients receive the best possible care is at the core of our mission,” said Roland Wandeler, President Grifols Biopharma Business Unit. “Our distribution strategy will enable us to maximize the availability of Grifols' top-tier intravenous and subcutaneous immunoglobulins across the U.S., offering patients a comprehensive range of effective treatment options.” Yimmugo, a key driver of Grifols Group’s U.S. growth strategy, will be followed by other Group proteins in this market, including fibrinogen and trimodulin, both in late-stage development. Its fibrinogen concentrate would be the first to receive a U.S. indication to treat acquired fibrinogen deficiency, while trimodulin is a polyvalent antibody composition for community-acquired pneumonia (CAP) or severe community-acquired pneumonia (sCAP). "With Yimmugo we are very excited to enter this important market for our industry and are committed to developing and delivering more therapies to patients in the U.S. in the coming years," said Peter Janssen, CEO of Biotest AG. "I am confident that Yimmugo will be a commercial success in the U.S. and provide an additional meaningful treatment option to patients." About Yimmugo® (IgG Next Generation) Yimmugo is a newly developed polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg). The sugar-free ready-to-use solution is approved in the US for substitution therapy in primary antibody deficiency syndromes. Yimmugo is the first approved product from the new Biotest Next Level production facility. The modern production process stands for the highest product quality and an extremely responsible use of resources. IMPORTANT SAFETY INFORMATION WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE See full Prescribing Information for YIMMUGO. Thrombosis may occur with immune globulin intravenous (IGIV) products, including YIMMUGO. (5.3) Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. YIMMUGO does not contain sucrose. (5.4) For patients at risk of thrombosis, renal dysfunction or renal failure, administer YIMMUGO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. (2.1, 2.3, 5.3) About Grifols Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces, and provides innovative healthcare services and solutions in more than 110 countries. Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology, and infectious diseases. A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East, and China. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with more than 23,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). For more information about Grifols, please visit MEDIA CONTACTS: Grifols Press Office media@grifols.com Tel. +34 93 571 00 02 INVESTORS: Grifols Investors Relations & Sustainability inversores@grifols.com - investors@grifols.com sostenibilidad@grifols.com - sustainability@grifols.com Tel. +34 93 571 02 21 LEGAL DISCLAIMER The facts and figures contained in this report that do not refer to historical data are “future projections and assumptions”. Words and expressions such as “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “will seek to achieve”, “it is estimated”, “future” and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.

上市批准

2024-06-17

·BioSpace

Grifols’ Biotest receives FDA approval for innovative Yimmugo® immunoglobulin to treat primary immunodeficiencies

With Biotest-developed Yimmugo, Grifols adds to its remarkable franchise of intravenous and subcutaneous immunoglobulins to meet strong demand Yimmugo, already approved for production and marketing in Europe, is the first U.S.-approved medicine in Biotest’s portfolio and is manufactured with an innovative process at Biotest’s new FDA-certified ‘Next Level’ facility U.S. approval of Yimmugo paves the way for other Biotest proteins in late-stage development, including fibrinogen and trimodulin Launching Yimmugoin the U.S. will over time significantly add to Grifols Group sales and underpins its future growth strategy BARCELONA, Spain, June 17, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), one of the world’s leading producers of plasma-derived medicines, today announced that Biotest, a Grifols Group company, has received approval from the United States Food and Drug Administration (FDA) for Yimmugo®, an innovative intravenous immunoglobulin (Ig) therapeutic, to treat primary immunodeficiencies (PID). Yimmugo, developed by Biotest, adds to Grifols’ strong franchise of industry-leading intravenous and subcutaneous Ig treatments at a time of growing demand for plasma-derived medicines to treat immunodeficiencies, in which a part of the body’s immune system is missing or does not function properly, and other medical conditions. The first U.S.-approved medicine in Biotest’s portfolio, Yimmugo is produced using a state-of-the-art process at Biotest’s new FDA-certified “Next Level” production facility in Dreieich, Germany, which is already approved for production and marketing in Europe. The launch of Yimmugo in the U.S. in the second part of 2024 follows its successful introduction in Europe at the end of 2022 and is poised to add to Grifols' future revenue growth and profitability. Yimmugo is the first of a threesome of Biotest plasma proteins on the horizon destined for markets including the U.S. The other two, both in late-stage development, are a fibrinogen concentrate (FC) to treat acquired fibrinogen deficiency – it would be the first FC approved for this indication in the U.S. – and trimodulin, a polyvalent Ig to treat community-acquired pneumonia (CAP) or severe community-acquired pneumonia (sCAP). “The addition of Biotest’s Yimmugo to our strong portfolio of intravenous and subcutaneous immunoglobulins provides another innovative treatment option for patients with primary immunodeficiencies who rely on these essential medicines in their daily lives,” said Roland Wandeler, President Grifols Biopharma Business Unit. The strategic acquisition of Biotest and the integration of its specialized resources has significantly accelerated Grifols innovation, deepened its product pipeline and furthered its industry leadership. About Yimmugo® (IgG Next Generation) Yimmugo is a newly developed polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg). The sugar-free ready-to-use solution is approved in the US for substitution therapy in primary antibody deficiency syndromes. Yimmugo is the first approved product from the new Biotest Next Level production facility. The modern production process stands for the highest product quality and an extremely responsible use of resources. IMPORTANT SAFETY INFORMATION WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE See full Prescribing Information for YIMMUGO. Thrombosis may occur with immune globulin intravenous (IGIV) products, including YIMMUGO. (5.3) Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. YIMMUGO does not contain sucrose. (5.4) For patients at risk of thrombosis, renal dysfunction or renal failure, administer YIMMUGO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. (2.1, 2.3, 5.3) About Grifols Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces, and provides innovative healthcare services and solutions in more than 110 countries. Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology, and infectious diseases. A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East, and China. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with more than 23,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). For more information about Grifols, please visit MEDIA CONTACTS: Grifols Press Office media@grifols.com Tel. +34 93 571 00 02 INVESTORS: Grifols Investors Relations & Sustainability inversores@grifols.com - investors@grifols.com sostenibilidad@grifols.com - sustainability@grifols.com Tel. +34 93 571 02 21 LEGAL DISCLAIMER The facts and figures contained in this report that do not refer to historical data are “future projections and assumptions”. Words and expressions such as “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “will seek to achieve”, “it is estimated”, “future” and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.

上市批准免疫疗法并购生物类似药

2024-02-28

·Pharmaceutical Technology

Grifols prepares for late-stage plans with plasma-derived medicines in 2024

In an exclusive interview with Pharmaceutical Technology, Grifols declared plans for multiple Phase III readouts in 2024. Credit: Bloomberg via Getty Images Grifols plans to release Phase III results of its long-term albumin treatment designed to increase survival time in patients with decompensated cirrhosis and ascites in 2024, says chief scientific innovations officer Jorg Schüttrumpf. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. You will receive an email shortly. Please check for download the Report. Related Company Profiles Grifols SA Ethicon US LLC Johnson & Johnson Biotest AG View all In an exclusive interview with Pharmaceutical Technology, Schüttrumpf outlined the plasma derived-medicines company’s 2024 goals for its late-stage candidates as several trials come to a head. The aforementioned Preciosa trial (NCT03451292) studying human albumin is focused on patients awaiting a suitable transplant. Grifols also plans to release data from its Phase III ESsCAPE study (NCT05722938), investigating trimodulin, triple action immunoglobulin with IgM, IgA and IgG, at some point this year. In February, the company reported positive efficacy results from a trial investigating Grifols’ fibrinogen concentrate (FC), BT524, for the treatment of acquired fibrinogen deficiency (AFD). The company now plans to complete European Medicines Agency (EMA) and US Food and Drug Administration (FDA) regulatory submissions, in pursuit of approval. “We are working with different partners. In the immunology, and pulmonary disease space, to support their growth,” says Schüttrumpf. Additionally, the Spain-headquartered company is exploring partnerships similar to the one it has with Ethicon, says Schüttrumpf. Grifols began its collaboration with Ethicon, a subsidiary of Johnson & Johnson , in 2017, wherein Grifols agreed to exclusively manufacture and supply plasma-derived products for use in the biosurgery field for 10 years. See Also: Pelage secures funds to develop regenerative medicine for hair loss Praxis Precision Medicines sees highest patent filings and grants during November in Q4 2023 In 2021, Grifols announced the acquisition of Tiancheng (Germany) Pharmaceutical Holding s, which owned 89.88% of another plasma products specialist Biotest . Grifols is developing trimodulin and B524 with Biotest. Before the acquisition, Grifols had already explored fibrinogen concentrate for the development of Vistaseal (fibrinogen (human) + thrombin (human), commercialised as Veraseal in Europe. Schüttrumpf highlights Grifol’s ability to complete in-house manufacturing for plasma-derived therapeutics like BT524. He said that this gave the company a major advantage in its operations, also allowing it to offer its manufacturing services to other pharmaceutical companies. Grifols has plans to release its 2023 annual financial report on 29 February. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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临床3期并购临床结果

100 项与 Trimodulin (Biotest) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
管状汗腺腺瘤	临床3期	美国	Biotest AG	2023-09-09
管状汗腺腺瘤	临床3期	阿根廷	Biotest AG	2023-09-09
管状汗腺腺瘤	临床3期	澳大利亚	Biotest AG	2023-09-09
管状汗腺腺瘤	临床3期	奥地利	Biotest AG	2023-09-09
管状汗腺腺瘤	临床3期	比利时	Biotest AG	2023-09-09
管状汗腺腺瘤	临床3期	巴西	Biotest AG	2023-09-09
管状汗腺腺瘤	临床3期	捷克	Biotest AG	2023-09-09
管状汗腺腺瘤	临床3期	法国	Biotest AG	2023-09-09
管状汗腺腺瘤	临床3期	德国	Biotest AG	2023-09-09
管状汗腺腺瘤	临床3期	匈牙利	Biotest AG	2023-09-09

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临床结果

适应症

分期

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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


NCT04576728 (ESsCOVID, Pubmed \| Eur J Med Res) 人工标引	临床2期	新型冠状病毒感染	166	Trimodulin	蓋衊築蓋構衊壓遞糧蓋(築鏇鏇積艱廠選齋窪願) = 範構衊鬱鏇壓繭襯網餘夢餘繭淵鹹觸簾範鏇製 (鹹遞壓鑰淵構範願糧憲 )	不佳	2024-08-13
				Placebo	蓋衊築蓋構衊壓遞糧蓋(築鏇鏇積艱廠選齋窪願) = 襯鏇鹽顧觸壓願範衊願夢餘繭淵鹹觸簾範鏇製 (鹹遞壓鑰淵構範願糧憲 )
NCT01420744 (CIGMA, Pubmed \| Intensive Care Med)	临床2期	社区获得性肺炎追加	160	Trimodulin	憲淵餘觸窪選鑰壓築遞(鏇艱鏇築鬱醖淵鏇衊繭) = 醖選糧齋製鑰醖繭積願淵簾夢鑰鏇獵鹹齋鬱艱 (顧餘製積艱醖鑰膚鹽鬱 )	-	2018-04-01
				Placebo	憲淵餘觸窪選鑰壓築遞(鏇艱鏇築鬱醖淵鏇衊繭) = 鏇鹽鹽蓋獵糧鏇獵顧鏇淵簾夢鑰鏇獵鹹齋鬱艱 (顧餘製積艱醖鑰膚鹽鬱 )