DGAP-News: Biotest AG
/ Key word(s): Study
16.07.2020 / 07:00
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Biotest submits phase II study with trimodulin for the treatment of severe COVID-19 patients
– 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, 16 July 2020. Biotest announced today that the ESsCOVID (Escape from severe COVID-19) trial for treatment of COVID-19 patients with trimodulin was submitted to the Competent Authority in Spain and the responsible Ethics Committee.
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 put forward by the European Medicines Agency (EMA) after a so-called “Rapid Scientific Advice”. Biotest aims at an expedited approval for 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).
“Based on its mode of action and due to the similarity of clinical symptoms to the patients treated in the CIGMA trial, we also see trimodulin as having considerable potential for treating patients with pneumonia caused by SARS-CoV-2 virus”, explains Dr. Andrea Wartenberg-Demand, Vice President Corporate Clinical Research and Development.
About trimodulin (IgM Concentrate)
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
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