DGAP-News: Biotest AG
/ Key word(s): Study
03.09.2020 / 07:00
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Biotest phase II study for the treatment of severe COVID-19 patients with trimodulin approved
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.
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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