DGAP-News: Biotest AG / Key word(s): Research Update
Biotest treats first COVID-19 patient with trimodulin
- 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
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, justifies the hypothesis that trimodulin has a considerable potential in the treatment of SARS-CoV-2 induced pneumonia.
"We are very pleased, to be able to support physicians with trimodulin for the treatment of patients with severe COVID-19. We hope, that trimodulin will be able to prevent progression of disease and improve patient outcome. As this would also reduce to need for invasive mechanical ventilation, it could alleviate possible capacity limitations within intensive care units", said Daniela Zipp, responsible Head of Clinical Operations at Biotest.
About trimodulin (IgM Concentrate)
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