Biotest AG: Biotest treats first COVID-19 patients with trimodulin in TRICOVID phase III trial
EQS-News: Biotest AG / Key word(s): Study
Biotest treats first COVID-19 patients with trimodulin in TRICOVID phase III trial
This multinational phase III clinical trial plans to enrol more than 330 adult hospitalized patients with moderate or severe COVID-19. These are patients with signs of early systemic inflammation admitted to hospital and requiring supplemental oxygen due to the severity of their disease. The trial will be conducted in Germany and up to 20 countries worldwide. After confirmation of SARS-CoV-2 infection, the patients will be treated either with trimodulin or with placebo as add-on therapy to standard of care.
The clinical concept of this prospective, double-blind, placebo-controlled phase III trial, was developed based on positive results from the phase II trial (ESsCOVID) in a subgroup of patients with early systemic inflammation and after the German Authority (Paul-Ehrlich-Institute) confirmed that further development is warranted.
Due to these results and the advanced development stage of trimodulin Biotest received substantial funding from the German Federal Ministry of Education and Research for this project (FKZ: 16LW0112) within the framework of the funding programme "Promotion of the clinical development of COVID-19 drugs and their manufacturing capacities", in order to facilitate rapid development of additional treatment options for hospitalized patients with COVID-19.
Biotest’s development product trimodulin is a worldwide unique, innovative polyvalent antibody composition, purified from human plasma. In addition to the clinical development in COVID-19, trimodulin treatment has already demonstrated promising results in a phase II clinical trial (CIGMA) with 160 invasive mechanically ventilated patients suffering from severe community-acquired pneumonia (sCAP). The phase III trial in sCAP (ESsCAPE) has been already submitted in some countries.
“We are very pleased to continue the development of trimodulin for a substantial group of hospitalized patients suffering from COVID-19. We expect, that trimodulin proves to be beneficial for these patients and improves their state of health by avoiding the need of mechanical ventilation and preventing death”, said Daniela Zipp, responsible Head of Clinical Operations at Biotest.
COVID-19 is a respiratory disease caused by the novel severe acute respiratory syndrome corona virus 2 variant (SARS-CoV-2). While most cases are mild or asymptomatic, COVID-19 patients may present at the hospital with typical signs of pneumonia requiring oxygen support. This disease stage is regularly accompanied by excessive immune responses and lung damage. Upon spread of the virus through the body, immune responses become dysregulated in the blood vessels which may trigger blood clotting throughout the body. This may cause microcirculatory disorders in vital organs and tissues including the lung and patients may progress to critical disease with need for intensive care and invasive mechanical ventilation. Additional leading to reversible or irreversible end-organ dysfunction may develop and even death may occur.
About trimodulin (IgM Concentrate)
Biotest’ development product trimodulin is an innovative polyvalent antibody composition, purified from human plasma. In comparison to standard IgG preparations (IVIG), trimodulin contains relevant amounts of IgM and IgA in addition to IgG. Trimodulin is currently in clinical development for the treatment of patients with severe community-acquired pneumonia (sCAP) and for patients with moderate or severe COVID-19. Research so far has shown that trimodulin could interfere with a number of mechanisms involved in pathological processes that would otherwise lead to respiratory failure, sepsis, multi-organ failure and finally to death of the patient. Due to the large variety of polyvalent antibodies present in trimodulin, the impaired immune system is supported in various ways. The antibodies bind to various types of pathogens including viruses and bacteria as well as their toxins and support their clearance by the immune system. Particularly the IgM component in trimodulin can reduce dysregulated immune responses, preventing the immune system to attack host tissues, in this case, the lung. In this way, trimodulin may prevent progression of disease, including the need for invasive mechanical ventilation and other intensive care procedures, and finally death.
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,200 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.
Dr Monika Buttkereit
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
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