Biotest AG: Biotest successfully completes recruitment for its clinical trial with trimodulin in severe COVID-19 patients
News: Biotest AG / Key word(s): Study
Biotest successfully completes recruitment for its clinical trial with trimodulin in severe COVID-19 patients
- Trimodulin as potential life-saving treatment for severe COVID-19 patients
- All 166 trial patients treated by end of June, first results expected for August 2021
- Positive recommendation from Data Safety and Monitoring Board (DSMB) after review of first 100 patients who completed treatment
- Expedited approval of trimodulin for severe COVID-19 planned for early 2022
A total of 166 adult patients with severe COVID-19 were enrolled in this multinational confirmatory phase II clinical trial. 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 were treated either with trimodulin or placebo as add-on therapy to standard of care.
An independent Data Safety and Monitoring Board (DSMB) reviewed the data from the first 100 patients who completed the trial. The DSMB did not detect any safety signal and recommended to continue the clinical trial according to protocol. Biotest therefore expects a favourable benefit-risk profile for trimodulin.
The clinical concept of this prospective, double-blind, placebo-controlled confirmatory phase II trial was developed according to the expectations of the European Medicines Agency (EMA) after a so-called "Rapid Scientific Advice". All patients will have completed the trial by end of June and first data is expected for August 2021. If supported by the trial outcome, 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 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). Trimodulin counteracts the dysregulated inflammatory responses observed in COVID-19 without suppressing the immune system.
"We are very pleased, to have completed this important milestone for the development of trimodulin. Now we are focusing to close the trial and to evaluate the results as soon as possible", said Dr. Iris Bobenhausen, Director for Clinical Trial Oversight at Biotest.
About trimodulin (IgM Concentrate)
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