Date: 2017-12-20
Type of
information: Results
phase: 2
Announcement: results
Company: Biotest (Germany)
Product: Trimodulin® (IgM Concentrate - IgM enriched immunoglobulin)
Action
mechanism:
- polyclonal antibody. Trimodulin® is a new polyclonal IgM enriched immunoglobulin derived from human plasma for the treatment of severe Community Acquired Pneumonia (sCAP). The 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.
Disease: severe community-acquired pneumonia (sCAP)
Therapeutic
area: Infectious diseases
Country:
Trial
details:
Latest
news:
- • On December 20, 2017, Biotest presented data from the Phase II study with Trimodulin® (IgM Concentrate) in 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.
Is
general: Yes
