PRESS RELEASE

Biotest proves the mode of action of trimodulin for the treatment of COVID-19

- Trimodulin limits pathological inflammatory responses

- Two new preclinical studies published on the mode of action of trimodulin in COVID-19

- Results of a prospective, double-blind, placebo-controlled Phase II study in severely ill COVID-19 patients expected soon

- Clinical results to be basis for accelerated approval

Dreieich, 3 August 2021. Trimodulin is a globally unique, innovative, polyvalent antibody preparation containing IgM, IgA and IgG antibodies, which is currently being investigated in a phase II clinical trial for the treatment of COVID-19. First impressive preclinical data on the mode of action of trimodulin in COVID-19 have been published by Biotest in renowned international scientific journals "Frontiers in Immunology" and "Biomedicines".

These publications summarizes results from the development of trimodulin. In severe COVID-19, complexes of viruses and antibodies of the patient are increasingly formed in the body, which can lead to a deregulated immune response. In the process activating messenger substances are increasingly released. Trimodulin reduces the release of these activating messenger substances on the one hand and increases the production of the body's own inhibitors of inflammation on the other.

Furthermore, a severe course of COVID-19 is associated with the activation of factors of the immunological defence system. The uncontrolled activation of these factors can damage cells in the lung tissue of patients, increase inflammatory reactions and lead to organ defects. The second work shows that trimodulin can neutralize such activated factors by binding and prevent the destruction of cells.

The two papers provide the basis for the mechanism of action of trimodulin in COVID-19.

About COVID-19
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)
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 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. 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.

About Biotest
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.

IR contact
Dr Monika Buttkereit
Phone: 06
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PR contact
Dirk Neumüller
Phone: 9
Mail:

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Disclaimer
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.

^[1] Bohländer F, Riehl D, Weißmüller S, Gutscher M, Schüttrumpf J, Faust S. Immunomodulation: Immunoglobulin Preparations Suppress Hyperinflammation in a COVID-19 Model via FcγRIIA and FcαRI. Front Immunol. 2021 Jun 10;12:700429.
/pmc/articles/PMC8223875/pdf/fimmu-12-700429.pdf
^[2] Schmidt C, Weißmüller S, Bohländer F, Germer M, König M, Staus A, Wartenberg-Demand A, Heinz CC, Schüttrumpf J. The Dual Role of a Polyvalent IgM/IgA-Enriched Immunoglobulin Preparation in Activating and Inhibiting the Complement System. Biomedicines. 2021; 9(7):817.
/2227-9059/9/7/817/pdf