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Biotest AG: Biotest successfully completes recruitment for its clinical trial with trimodulin in severe COVID-19 patients

News: Biotest AG / Key word(s): Study
02.06.2021 / 07:00
The issuer is solely responsible for the content of this announcement.


Biotest successfully completes recruitment for its clinical trial with trimodulin in severe COVID-19 patients

- Trimodulin as potential life-saving treatment for severe COVID-19 patients

- All 166 trial patients treated by end of June, first results expected for August 2021

- Positive recommendation from Data Safety and Monitoring Board (DSMB) after review of first 100 patients who completed treatment

- Expedited approval of trimodulin for severe COVID-19 planned for early 2022

Dreieich, 2 June 2021. Biotest announced today the completion of recruitment for its ESsCOVID (Escape from severe COVID-19) trial in patients with severe COVID-19.

A total of 166 adult patients with severe COVID-19 were enrolled in this multinational confirmatory phase II clinical trial. These are patients with pneumonia or acute respiratory distress syndrome (ARDS) admitted to hospital due to the severity of their disease. After confirmation of SARS-CoV-2 infection and presence of a strong inflammatory response, the patients were treated either with trimodulin or placebo as add-on therapy to standard of care.

An independent Data Safety and Monitoring Board (DSMB) reviewed the data from the first 100 patients who completed the trial. The DSMB did not detect any safety signal and recommended to continue the clinical trial according to protocol. Biotest therefore expects a favourable benefit-risk profile for trimodulin.

The clinical concept of this prospective, double-blind, placebo-controlled confirmatory phase II trial was developed according to the expectations of the European Medicines Agency (EMA) after a so-called "Rapid Scientific Advice". All patients will have completed the trial by end of June and first data is expected for August 2021. If supported by the trial outcome, Biotest aims for an expedited approval of trimodulin to rapidly respond to the need for novel treatment options for patients with severe COVID-19.

Biotest's development product is a worldwide unique, innovative antibody preparation. Trimodulin treatment has already demonstrated promising results in a phase II clinical trial with 160 invasive mechanically ventilated patients suffering from severe community-acquired pneumonia (sCAP) with a strong inflammatory response (CIGMA trial). Trimodulin counteracts the dysregulated inflammatory responses observed in COVID-19 without suppressing the immune system.

"We are very pleased, to have completed this important milestone for the development of trimodulin. Now we are focusing to close the trial and to evaluate the results as soon as possible", said Dr. Iris Bobenhausen, Director for Clinical Trial Oversight at Biotest.

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)
Biotest' development product trimodulin is an innovative immunoglobulin preparation, purified from human blood 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. 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.

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: +49-6103-801-4406

PR contact
Dirk Neumüller
Phone: +49-6103-801-269

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany,

Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

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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