PRESS RELEASE

Biotest expands its clinical development program for trimodulin to patients with community-acquired pneumonia (CAP)

• Trimodulin is a globally unique, innovative human plasma protein preparation in advanced development
• Clinical development of trimodulin is conducted in two clinical trials in the therapeutic area of respiratory tract infections:
  • ESsCAPE trial: Ongoing phase III trial in patients with severe community-required pneumonia (sCAP) requiring mechanical ventilation
  • TRICOVID trial: Ongoing phase III trial in patients with COVID-19 was expanded to include also CAP patients

Dreieich, 12 December 2023. Biotest announced this week that the first hospitalized patient with Community-Acquired Pneumonia (CAP) has been treated in the multinational phase III TRICOVID trial.

The TRICOVID trial was already enrolling hospitalized patients with COVID-19 who require supplemental oxygen due to the severity of their disease. COVID-19 is a community-acquired pneumonia (CAP) caused by a specific pathogen, the SARS-CoV-2 virus. However, trimodulin is not only expected to be effective in treatment of COVID-19 patients. Trimodulin contains a wide spectrum of antibodies that target other pathogens, including bacteria, fungi and other viruses that may cause infections in the lung. Accordingly, the ongoing TRICOVID trial has now been opened for enrolment of patients with CAP caused by any type of pathogen.

Independent of the pathogen causing the infection, pneumonia remains a life-threatening condition. CAP may aggravate to severe CAP with need for oxygen supplementation through mechanical ventilation. These patients may 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. Therefore, this ongoing TRICOVID trial aims to treat patients with CAP at an early disease stage, to prevent worsening to severe CAP, the need of mechanical ventilation and possibly even death.

In another ongoing phase III trial (ESsCAPE trial), patients with a severe form of CAP, and already requiring mechanical ventilation are treated with trimodulin to prevent further critical illness and to reduce the risk of death.

With these two ongoing phase III trials, now covering a broad patient population with CAP and sCAP, Biotest further expedites the clinical development of trimodulin in the therapeutic area of respiratory tract infections.

“We are very pleased about the opportunity to expand the trial population of the ongoing TRICOVID trial to patients with community-acquired pneumonia independent of the causative pathogen. This further expedites the development of trimodulin as potential new treatment option for a broad population of hospitalized patients with CAP”, emphasized Dr Thomas Häder, Head of Clinical Strategy and Development at Biotest.

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 community acquired pneumonia (CAP)

CAP is clinically defined as pneumonia acquired from outside the hospital. While most cases are mild or asymptomatic, CAP including COVID-19 patients may present at the hospital with typical signs of pneumonia requiring supplemental oxygen supply. Severe CAP (sCAP) is usually defined as CAP that requires intensive medical care due to the need for invasive mechanical ventilation or development of septic shock with need for vasopressors. 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 biological therapeutics derived from human plasma. 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.

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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.