PRESS RELEASE

Biotest’s Trimodulin shows reduced mortality in patients with severe community-acquired pneumonia through rapid normalisation of inflammation

• Trimodulin is a globally unique, innovative human plasma protein preparation in advanced development for treatment of pneumonia
• Trimodulin supports and modulates the dysregulated immune system of patients with severe community-acquired pneumonia (sCAP)
• This mechanism has the potential to provide a relevant survival benefit for sCAP patients

Dreieich, 28 November 2023. New data on trimodulin have recently been published in “Critical Care”, a high quality, international clinical medical journal[1]. The article describes new mechanisms by which trimodulin supports the immune system in patients with severe Community-Acquired Pneumonia (sCAP).

Severe CAP is a life-threatening infectious disease. Patients must be admitted to an intensive care unit and often require artificial ventilation with oxygen. One major characteristic of sCAP patients is that their immune system becomes dysregulated, which results in inflammation. This may further aggravate the disease course and accordingly these patients are at high risk to develop additional critical illnesses such as sepsis, septic shock, and multiple organ dysfunction or failure.

Despite existing antimicrobial treatment options, mortality in these patients remains high. Trimodulin contains a wide spectrum of pathogen targeting antibodies (polyvalent immunoglobulins M, A and G), which laboratory experiments have also indicated inflammation-reducing properties. In accordance with this thesis, it was shown previously that particularly sCAP patients with severe inflammation benefit from trimodulin treatment, demonstrated by a marked reduction in mortality compared to the control group. This beneficial data make the ESsCAPE trial, which started in September, even more interesting.

In the new analyses, the underlying mechanism for reduction in mortality in sCAP patients was investigated. The data show that trimodulin not only replenishes the immunoglobulin concentrations, but also quickly restores immune cell numbers back to normal. In parallel, large fluctuations in the level of inflammatory markers caused by overwhelming immune responses in the patients, are quickly stabilized by trimodulin. These data indicate that trimodulin quickly supports and stabilizes the dysregulated immune system. Particularly in patients with such signs of immune dysregulation, trimodulin significantly decreased the length of invasive mechanical ventilation and most importantly, decreased the mortality rate. This was even more prominent in patients with low immunoglobulin M levels.

“This report reveals new and exciting data and provide potential mechanistic insights and useful markers that help to select the right patient for treatment with trimodulin,” said Mervyn Singer, Professor of Intensive Care Medicine at University College London.

Biotest’s development product trimodulin is a globally unique, innovative polyvalent IgM, IgA, IgG antibody preparation, purified from human plasma. The results reported, support the currently ongoing investigation of trimodulin in artificial ventilated patients with sCAP with evidence of significant inflammation (ESsCAPE trial). In addition, trimodulin is currently also in development for the treatment of hospitalized, oxygen-supported patients with non-severe CAP, including COVID-19 (TRICOVID trial).

About trimodulin (IgM Concentrate)

Biotest’s 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, which offer defence against a broad spectrum of germs and antigens. Trimodulin is currently in clinical development for the treatment of patients with severe community-acquired pneumonia (sCAP) and for patients with non-severe CAP including moderate/severe COVID-19 pneumonia. 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.

About severe community acquired pneumonia (sCAP)

Severe community acquired pneumonia (sCAP) is usually defined as pneumonia acquired outside the hospital that requires intensive medical care. Mortality of sCAP patients admitted to the intensive care unit is high and has not improved much in recent years.

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 2,400 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 Baumann (Buttkereit)
Phone: +49-6103-801-4406
Mail: ir@biotest.com

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Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

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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.

^[1] Singer et al., Crit Care. 2023 Nov 9; 27(1):436. doi: 10.1186/s13054-023-04719-9.