DGAP-News: Biotest AG
/ Key word(s): Research Update
11.10.2021 / 07:00
The issuer is solely responsible for the content of this announcement.
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.
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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