Trimodulin: concept for phase III study successfully coordinated with the authorities
- Clinical concept of the Phase III study is supported by the regulatory authorities
- Optimized production process successful developed
Dreieich, 20 December 2017. In 2017, Biotest presented data from the Phase II study with Trimodulin (IgM Concentrate) in the indication severe community-acquired pneumonia (sCAP) and the further clinical development concept to the regulatory authorities. The authorities support this approach and the planned phase III study.
At the same time, the authorities recommend that Biotest carries out further technical optimization according to the latest scientific findings in the production process. Biotest has already successfully completed the development work to meet these regulatory requirements. Currently, this technology is being implemented on a production scale. The start of the phase III study is planned after finalizing the technical optimization in approximately one year.
About Severe Community-Acquired Pneumonia (sCAP)
Severe Community-Acquired Pneumonia (sCAP) is usually defined as pneumonia acquired outside the hospital that requires intensive medical care. Mortality of sCAP patients admitted to the Intensive Care Unit (ICU) is up to 23-58 % depending on time and admission of the patient and has not improved much in recent years.
About Trimodulin (IgM Concentrate)
Trimodulin (IgM Concentrate - IgM enriched immunoglobulin) is a new polyclonal IgM enriched immunoglobulin derived from human plasma for the treatment of severe Community Acquired Pneumonia (sCAP). Trimodulin (IgM Concentrate) acts through a wide range of mechanisms interfering with pathophysiological processes which otherwise could lead to severe respiratory disturbances, severe sepsis, multiorgan failure and ultimately death of the patient. Besides neutralisation of bacterial endotoxin and exotoxin, IgM mediates increased recognition of pathogens by certain immune cells and promotes their destruction. In addition, IgM can rebalance excessive immune responses and possesses anti-inflammatory properties.
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,500 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
Dr. Monika Buttkereit
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hanover, Munich, Stuttgart
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.
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