Biotest identifies a benefit with trimodulin in a relevant subgroup of hospitalised COVID-19 patients
- Complete data set from the phase II ESsCOVID trial analysed
- Post hoc subgroup analyses revealed a medical relevant benefit in hospitalised COVID-19 patients with early systemic inflammation
- Biotest considers further clinical development of trimodulin in COVID-19
Dreieich, 11 October 2021. Biotest announced today that analysis of the complete data set of the ESsCOVID (Escape from severe COVID-19) trial revealed efficacy of trimodulin in a relevant subgroup of severely ill COVID-19 patients. No relevant safety concerns have been identified confirming the good safety profile of trimodulin.
In this multinational phase II clinical trial, 166 adult patients with severe COVID-19 were enrolled worldwide. Patients with pneumonia or acute respiratory distress syndrome (ARDS) were admitted to hospital with a dysregulated systemic inflammatory response. After confirmation of SARS-CoV-2 infection, patients with signs of systemic inflammation were treated either with trimodulin or with placebo as add-on therapy to standard of care. Aim (primary endpoint) was to prevent patients from worsening (e.g. need for invasive mechanical ventilation) and to prevent death of the patients.
Biotest recently received the complete data set of the ESsCOVID trial. Initial data showed that the primary endpoint of the trial was not met in the overall trial population, which included also patients with an already advanced systemic inflammation. However, the detailed post-hoc analyses of the complete data set revealed a notable benefit in a relevant subgroup of hospitalised patients with early systemic inflammation. In this subgroup of 96 COVID-19 patients trimodulin was able to markedly reduce both worsening and mortality of patients compared to placebo treated patients.
"Based on these clear beneficial and medical relevant results, we see trimodulin as having considerable potential for a considerable number of hospitalized COVID-19 patients", explains Dr. Andrea Wartenberg-Demand, Vice President Corporate Clinical Research and Development.
Biotest considers the reduction of deterioration and mortality rate as a relevant medical benefit indicative to continue the development of trimodulin in this target population.
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 advanced systemic inflammation and with need for intensive care, including invasive mechanical ventilation.
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 1,900 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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