Biotest treats first COVID-19 patient with trimodulin
- A clear reduction in mortality and in duration of ventilation support during intensive care stay is expected
- Worldwide unique, innovative plasma protein preparation for treatment of COVID-19 patients
- Expedited approval of trimodulin for COVID-19 intended
Dreieich, 6 October 2020. Biotest announced today that the first patient with severe COVID-19 was treated in Spain with trimodulin in the ESsCOVID (Escape from severe COVID-19) trial. Furthermore has the trial been submitted for approval to the Regulatory Agencies in Russia, Brazil and now also in France.
In this multinational phase II clinical trial, approximately 160 adult patients with severe COVID-19 are planned to be enrolled. These are patients with pneumonia or acute respiratory distress syndrome (ARDS) admitted to hospital due to the severity of their disease. After confirmation of SARS-CoV-2 infection and presence of a strong inflammatory response, 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 II trial, was developed according to the expectations of the European Medicines Agency (EMA) after a so-called "Rapid Scientific Advice". Biotest aims for an expedited approval of trimodulin to rapidly respond to the need for novel treatment options for patients with severe COVID-19.
Biotest's development product trimodulin is a worldwide unique, innovative antibody preparation. Trimodulin treatment has already demonstrated promising results in a phase II clinical trial with 160 invasive mechanically ventilated patients suffering from severe community-acquired pneumonia (sCAP) with a strong inflammatory response (CIGMA trial).
The similarity of the COVID-19 symptoms to the patients treated in the CIGMA trial, justifies the hypothesis that trimodulin has a considerable potential in the treatment of SARS-CoV-2 induced pneumonia.
"We are very pleased, to be able to support physicians with trimodulin for the treatment of patients with severe COVID-19. We hope, that trimodulin will be able to prevent progression of disease and improve patient outcome. As this would also reduce to need for invasive mechanical ventilation, it could alleviate possible capacity limitations within intensive care units", 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 an excessive immune response and can lead to systemic inflammation reactions. Furthermore, patients may progress to critical disease with need for intensive care, including invasive mechanical ventilation. This clinical picture and course of the disease resembles that of sCAP caused by other pathogens.
About trimodulin (IgM Concentrate)
Biotest' development product trimodulin is an innovative immunoglobulin preparation, purified from human blood 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 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.
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 1,900 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
Preference shares: securities' ID No. 522723; ISIN DE0005227235
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This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.
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