Trimodulin does not reach the primary endpoint in the phase II trial in patients with severe COVID-19
- First results do neither show an improvement in the course of the disease nor in mortality compared to the placebo group.
- Trimodulin still demonstrates a good safety profile
- Biotest does not aim for approval in COVID-19
Dreieich, 13. August 2021. Biotest announced today the outcome for its ESsCOVID (Escape from severe COVID-19) trial in patients with severe COVID-19. Topline data for the primary endpoint demonstrate no reduction in number of patients that either clinically worsened (deterioration rate) or died during the trial (mortality rate) compared to the placebo group.
A total of 166 adult patients with severe COVID-19 were enrolled in this multinational phase II clinical trial. Patients admitted to the hospital due to the severity of their disease were treated either with trimodulin or placebo as add-on therapy to standard of care.
In contrast to the positive results from the earlier phase II trial with trimodulin in patients with severe community-acquired pneumonia no treatment benefit was achieved in the new indication COVID-19.
From the currently available data no relevant safety concerns have been identified confirming the good safety profile of trimodulin.
Biotest will communicate more detailed results after receipt and analysis of the complete dataset within the next weeks.
"My special thanks go to the patients, the study centers and the entire team who worked despite many obstacles day and night on the trimodulin development in COVID-19" said Dr Michael Ramroth, CEO 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.
About trimodulin (IgM Concentrate)
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). 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. Particularly the IgM component in trimodulin can reduce dysregulated immune responses, preventing the immune system to attack host tissues, in this case the lung. The polyvalent antibodies also bind to various types of pathogens including viruses and bacteria as well as their toxins and support their clearance by the immune system. 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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