Biotest phase II study for the treatment of severe COVID-19 patients with trimodulin approved
- A clear reduction in mortality and in duration of ventilation support during intensive care stay is expected
- Worldwide unique, innovative plasma protein preparation for treatment of COVID-19 patients
- Expedited approval of trimodulin for COVID-19 intended
Dreieich, 3 September 2020. Biotest announced today that the ESsCOVID (Escape from severe COVID-19) trial for treatment of COVID-19 patients with trimodulin was approved by the Competent Authority and the responsible Ethics Committee in Spain. In addition, the study has now also been submitted for approval in Russia and Brazil.
In this multinational phase II clinical trial, approximately 160 adult patients with severe COVID-19 are planned to be enrolled. 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 will be treated either with trimodulin or with placebo as add-on therapy to standard of care.
The clinical concept of this prospective, double-blind, placebo-controlled phase II trial, was developed according to the expectations of the European Medicines Agency (EMA) after a so-called "Rapid Scientific Advice". 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 trimodulin 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).
The similarity of the COVID-19 symptoms to the patients treated in the CIGMA trial, suggests a considerable potential for trimodulin in the treatment of SARS-CoV-2 induced pneumonia.
"We are very pleased about the agreement to our trial concept by the Spanish Competent Authority. With the approval of the trial we are now preparing the initiation of selected study centers to enable treatment of COVID-19 patients with trimodulin as fast as possible", said Dr. Thomas Häder, responsible Head of Clinical Strategy & Development at Biotest.
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.
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 1,800 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.
Dr Monika Buttkereit
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
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