A Randomized, Active-controlled, Multicenter, Phase III Study Investigating Efficacy and Safety of Intra-operative Use of BT524 (Human Fibrinogen Concentrate) in Subjects Undergoing Major Spinal or Abdominal Surgery (AdFIrst)

The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired hypofibrinogenemia. This non-inferiority study focused on the primary objective of demonstrating that BT524 is non-inferior that means not worse than the comparator fresh frozen plasma/cryoprecipitate in reducing intraoperative blood loss when administered intravenously in subjects with acquired hypofibrinogenemia undergoing elective major spinal or abdominal surgery.

Start Date03 Apr 2018

Sponsor / Collaborator

Biotest AG

[+2]

NCT02065882 / CompletedPhase 3

A Prospective, Open-label, Phase I/III Study Investigating Pharmacokinetic Properties of BT524 and Efficacy and Safety of BT524 in the Treatment and Prophylaxis of Bleeding in Patients With Congenital Fibrinogen Deficiency

The purpose of the study is to investigate pharmacokinetics, efficacy and safety of BT524 in patients with congenital fibrinogen deficiency.

Start Date01 Mar 2013

Sponsor / Collaborator

Biotest AG

[+4]

100 Clinical Results associated with Fibrinogen concentrate (Biotest AG)

100 Translational Medicine associated with Fibrinogen concentrate (Biotest AG)

100 Patents (Medical) associated with Fibrinogen concentrate (Biotest AG)

407

Literatures (Medical) associated with Fibrinogen concentrate (Biotest AG)

01 Oct 2024·Trauma Case Reports

Effective use of fibrinogen concentrate in a pediatric splenic injury requiring transcatheter arterial embolization

Article

Author: Atsumi, Takahiro ; Ando, Sho ; Dote, Hisashi ; Okuma, Seigo

Correction of coagulation is a crucial aspect of trauma care. While there are reports highlighting the effectiveness of fibrinogen concentrate in severe trauma cases with coagulopathic complications, literature on its use in pediatric cases remains limited. This paper discusses the case of a 5-year-old male presenting with a splenic injury and associated coagulopathy. We administered fibrinogen concentrate to enhance his coagulability prior to performing transcatheter arterial embolization utilizing gelatin sponges, aiming for optimal hemostasis. Post-administration, the patient's fibrinogen levels improved significantly, leading to successful hemostasis and a positive clinical outcome.

01 Aug 2024·eJHaem

Iatrogenic hemorrhage and extensive venous thromboembolism during iTTP treatment with caplacizumab—A case report

Article

Author: Ljungqvist, Maria ; Bruzelius, Maria ; Kimiaei, Adrian ; Boberg, Erik ; Ågren, Anna ; Karlström, Cecilia

AbstractCaplacizumab reduces the need for therapeutic plasma exchange (TPE) during treatment for thrombotic thrombocytopenic purpura (TTP), associates with fewer required TPE, and shortens hospital stay. It is therefore recommended as part of standard care. However, the treatment effects on hemostasis may complicate initial management. We present a case of a woman with immune‐mediated TTP who developed an intrathoracic hemorrhage on caplacizumab treatment after replacement of her central venous catheter. Reduced von Willebrand factor (vWF):glycoprotein Ib mutant (GPIbM) activity was reversed using vWF concentrate and the bleeding stopped. Unfortunately, vWF substitution in combination with caplacizumab discontinuation likely contributed to subsequent extensive venous thromboembolism. Risk‐reducing strategies against both bleeding and thrombosis are crucial during caplacizumab treatment, and emergency vWF substitution increases the already high risk of thrombosis associated with TPE.

01 Jul 2024·Chinese Journal of Traumatology

Empirical and modified hemostatic resuscitation for liver blast injury combined with seawater immersion: A preliminary study

Article

Author: Dai, Chenglin ; Zhong, Xin ; Jia, Yijun ; Du, Wenqiong ; Yang, Haoyang ; Jiang, Renqing ; Ye, Zhao ; Zong, Zhaowen ; Chen, Can ; Zhang, Dongzhaoyang

PURPOSETo compare the effects of empirical and modified hemostatic resuscitation for liver blast injury combined with seawater immersion.METHODSThirty rabbits were subjected to liver blast injury combined with seawater immersion, and were then divided into 3 groups randomly (n = 10 each): group A (no treatment after immersion), group B (empirical resuscitation with 20 mL hydroxyethyl starch, 50 mg tranexamic acid, 25 IU prothrombin complex concentrate and 50 mg/kg body weight fibrinogen concentrate), and group C (modified resuscitation with additional 10 IU prothrombin complex concentrate and 20 mg/kg body weight fibrinogen concentrate based on group B). Blood samples were gathered at specified moments for assessment of thromboelastography, routine coagulation test, and biochemistry. Mean arterial pressure, heart rate, and survival rate were also documented at each time point. The Kolmogorov-Smirnov test was used to examine the normality of data distribution. Multigroup comparisons were conducted with one-way ANOVA.RESULTSLiver blast injury combined with seawater immersion resulted in severe coagulo-fibrinolytic derangement as indicated by prolonged prothrombin time (s) (11.53 ± 0.98 vs. 7.61 ± 0.28, p＜0.001), activated partial thromboplastin time (APTT) (s) (33.48 ± 6.66 vs. 18.23 ± 0.89, p＜0.001), reaction time (R) (min) (5.85 ± 0.96 vs. 2.47 ± 0.53, p＜0.001), decreased maximum amplitude (MA) (mm) (53.20 ± 5.99 vs. 74.92 ± 5.76, p＜0.001) and fibrinogen concentration (g/L) (1.188 ± 0.29 vs. 1.890 ± 0.32, p = 0.003), and increased D-dimer concentration (mg/L) (0.379 ± 0.32 vs. 0.051 ± 0.03, p = 0.005). Both empirical and modified hemostatic resuscitation could improve the coagulo-fibrinolytic states and organ function, as indicated by shortened APTT and R values, decreased D-dimer concentration, increased fibrinogen concentration and MA values, lower concentration of blood urea nitrogen and creatine kinase-MB in group B and group C rabbits in comparison to that observed in group A. Further analysis found that the R values (min) (4.67 ± 0.84 vs. 3.66 ± 0.98, p = 0.038), APTT (s) (23.16 ± 2.75 vs. 18.94 ± 1.05, p = 0.001), MA (mm) (60.10 ± 4.74 vs. 70.21 ± 3.01, p < 0.001), and fibrinogen concentration (g/L) (1.675 ± 0.21 vs. 1.937 ± 0.16, p = 0.013) were remarkably improved in group C than in group B at 2 h and 4 h after injury. In addition, the concentration of blood urea nitrogen (mmol/L) (24.11 ± 1.96 vs. 21.00 ± 3.78, p = 0.047) and creatine kinase-MB (U/L) (85.50 ± 13.60 vs. 69.74 ± 8.56, p = 0.013) were lower in group C than in group B at 6 h after injury. The survival rates in group B and group C were significantly higher than those in group A at 4 h and 6 h after injury (p < 0.001), however, there were no statistical differences in survival rates between group B and group C at each time point.CONCLUSIONSModified hemostatic resuscitation could improve the coagulation parameters and organ function better than empirical hemostatic resuscitation.

News (Medical) associated with Fibrinogen concentrate (Biotest AG)

17 Jun 2024

·www.pharmaceutical-technology.com

Biotest wins FDA approval for plasma protein therapy

The FDA approved Biotest’s plasma protein therapy as per a 17 June press release. Credit: Biotest. Biotest , a subsidiary of Grifols , announced that the US FDA granted approval for its plasma protein therapy Yimmugo earlier today (17 June). Yimmugo is an intravenous immunoglobulin therapy developed as a substitution therapy for primary antibody deficiency syndromes. The Barcelona, Spain-headquartered company launched the therapy in Europe in late 2022, receiving European Medicines Agency (EMA) approval for production and marketing. Biotest is developing the therapy at a production facility in Dreieich, Germany. The therapy uses a polyvalent immunoglobulin G preparation from human blood plasma for producing intravenous administration (IVIg). Antibody deficiency syndrome is caused by an immunoglobulin level significantly under the standard range or a failure of immunoglobulin function. The primary form of the condition is developed due to genetic defects that dysregulate B cell development and/or function. Earlier this year, Biotest announced an 83.6% increase in first-quarter (Q1) sales driven by Yimmugo. The company reported revenues of €215.2m ($230.5m) in Q1 2024, with Yimmugo’s sales jumping from €7.5m to €11.1m. In a 17 June press release, Peter Janssen, Biotest’s CEO, said: “With this approval, we aim to increase the availability of and access to immunoglobulin therapies worldwide, thereby improving patient care.” See Also: Johnson & Johnson seeks FDA approval for Tremfya for Crohn’s disease AstraZeneca’s Truqap and Faslodex combo receives approval in EU Alongside Yimmugo, Biotest has been developing two other plasma proteins. One of these is a fibrinogen concentrate therapy, AdFIrst (BT524), for the treatment of acquired fibrinogen deficiency. In 2021, Biotest came under Grifols via the acquisition of Tiancheng Pharmaceutical, which owned a majority of the shares in Biotest. Earlier this year, Grifols’ chief scientific innovations officer, Jörg Schüttrumpf, said the company has the capability to manufacture Adfirst in-house . Grifols released a positive readout from a Phase III AdFIrst study (2017-001163-20) in February 2024, demonstrating that the therapy was non-inferior to the standard of care. Biotest is also developing trimodulin (BT-588), a plasma protein treatment for severe community-acquired pneumonia. The pharma company is currently investigating the therapy in the Phase III ESsCAPE study (NCT05722938).

Clinical ResultDrug ApprovalPhase 3ImmunotherapyAcquisition

28 Feb 2024

·www.pharmaceutical-technology.com

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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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.

Phase 3AcquisitionClinical Result

14 Feb 2024

·www.fiercepharma.com

Grifols readies US, EU approval push for blood clot treatment after phase 3 success

BT524 can be administered to “patients on the operating table immediately," Grifols explained. Grifols is readying an approval run at U.S. and European regulators on the back of a phase 3 win for the Spanish plasma medicine producer's concentrated form of a blood clotting factor. The product, dubbed BT524, is a concentrated form of fibrinogen, a glycoprotein that is essential for blood clot formation and stops excessive bleeding resulting from injuries or surgery. Grifols was testing BT524 in a late-stage study of patients with acquired fibrinogen deficiency (AFD), which it described as an “underserved growth market.” The Barcelona, Spain-based company announced this morning that the product had met the study’s primary endpoint, demonstrating its noninferiority to standard of care when it came to reducing blood loss in patients with AFD who underwent spinal or abdominal surgery, while also “maintaining an excellent safety profile.” Specifically, mean blood loss was 1,444 mL among the BT524 cohort compared with 1,735 mL among patients who received standard of care. It meant patients receiving Grifols’ product lost an average of 291 mL less blood. AFD usually occurs during surgery when a patient’s body contains insufficient fibrinogen to arrest bleeding. It is typically treated with a plasma extract called cryoprecipitate or fresh frozen plasma, which both contain fibrinogen. However, both of these treatment options contain various other unneeded proteins and elements, meaning that large volumes are required to ensure the patient receives sufficient fibrinogen, Grifols explained in the release. They also need to be thawed before use, which is not only time-consuming but can put patients’ lives at risk, the company added. In contrast, BT524 can be administered to “patients on the operating table immediately,” who will only receive the fibrinogen necessary to prevent hemorrhaging, Grifols explained. The company’s plan is to kick off the approval process in both Europe and the U.S. in the fourth quarter of the year. If successful, it would mark the first fibrinogen concentrate approved for AFD in the U.S., Grifols noted. “The positive results for fibrinogen are an important milestone and strengthen a Grifols innovation strategy that’s diversified across plasma and non-plasma, balanced between internal and external investments, and includes both shorter- and longer-term development cycles,” Grifols’ chief operating officer, Victor Grifols Deu, said in the release. While Grifols has its eye on the first fibrinogen concentrate approval for AFD in the U.S., its competitors have had more luck getting their own versions to market for congenital fibrinogen deficiency. CSL Behring got RiaSTAP approved in that indication as far back as 2009, while Switzerland’s Octapharma followed suit with Fibryga in 2017. Since then, Fibryga has also received approval to treat AFD across Europe off the back of a phase 2 study. Meanwhile, Grifols is in the midst of an ongoing legal battle with Gotham City Research after the New York hedge fund accused the company of wrongful accounting practices.

Drug ApprovalClinical ResultPhase 3Phase 2

100 Deals associated with Fibrinogen concentrate (Biotest AG)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Afibrinogenemia	Phase 3	TN	Biotest AG	01 Mar 2013
Afibrinogenemia	Phase 3	DE	Biotest AG	01 Mar 2013
Afibrinogenemia	Phase 3	LB	Biotest AG	01 Mar 2013
Hemorrhage	Phase 3	BG	Biotest AG	01 Mar 2013
Hemorrhage	Phase 3	EG	Biotest AG	01 Mar 2013
Hemorrhage	Phase 3	TN	Biotest AG	01 Mar 2013
Hemorrhage	Phase 3	LB	Biotest AG	01 Mar 2013
Hemorrhage	Phase 3	DE	Biotest AG	01 Mar 2013
Afibrinogenemia	Discovery	BG	Biotest AG	01 Mar 2013
Afibrinogenemia	Discovery	EG	Biotest AG	01 Mar 2013

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03444324 \| EUCTR2017-001163-20-DE (AdFIrst, Corporate Publications) Manual	Phase 3	Acquired fibrinogen deficiency	222	BT524	(wbxzvfwzuw) = lmdwdiydoy gdldrcmuno (wsvudxkpdx ) Met	Positive	14 Feb 2024
				Standard of Care	(wbxzvfwzuw) = ahdvbcibau gdldrcmuno (wsvudxkpdx ) Met

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