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Biotest treats first patient with severe community-acquired pneumonia in phase III trial with trimodulin

• Trimodulin is a globally unique, innovative human plasma protein preparation in advanced development
• Development in a therapeutic area of high unmet medical need
• Significant reduction in mortality expected in patients on invasive mechanical ventilation with severe community acquired pneumonia (sCAP)

Dreieich, 12 September 2023. Biotest announced today that the first patient with sCAP has been treated in the phase III ESsCAPE trial in an intensive care unit.

This multinational phase III clinical trial is expected to enrol approximately 590 adult patients with severe Community Acquired Pneumonia (sCAP). The ESsCAPE trial will be conducted in up to 20 countries worldwide and patients will receive either trimodulin or placebo as add-on therapy to standard of care.

Severe CAP is a life-threatening condition. Patients must be admitted to an intensive care unit (ICU) and often receive oxygen through invasive mechanical ventilation (IMV). These patients often develop additional critical illnesses such as sepsis, septic shock, and multiple organ dysfunction or failure. Despite existing treatment options, mortality in these patients remains high.

The clinical concept of this prospective, double-blind, placebo-controlled phase III trial, was developed based on the promising results of the previous phase II clinical trial (CIGMA) in 160 sCAP patients requiring IMV. In the CIGMA trial a subgroup of patients with evidence of severe inflammation showed an encouraging reduction in the mortality rate when treated with trimodulin.

“We are pleased to continue the clinical development of trimodulin, as there is a high unmet medical need to reduce the mortality in this critically ill patient population with sCAP,” said Daniela Zipp, responsible Head of Clinical Operations at Biotest.

Biotest’s development product trimodulin is a globally unique, innovative polyvalent IgM, IgA, IgG antibody composition, purified from human plasma. In addition to clinical development for sCAP, trimodulin is also currently in development for the treatment of COVID-19.

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. 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.

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 2,300 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: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Dirk Neumüller

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

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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.