Development pipeline

IgM Concentrate

IgM Concentrate is a new immunoglobulin preparation enriched with immunoglobulin M (IgM) for the treatment of severe community acquired pneumonia (sCAP).

IgM Concentrate acts through a range of mechanisms which are expected to counteract the pathophysiological processes which can otherwise lead to severe respiratory disturbances, severe sepsis with multiorgan failure and to death of the patient.

Besides neutralisation of bacterial endotoxin and exotoxin, IgM mediates increased recognition of bacteria by certain immune cells and promotes their destruction. In addition, IgM can counteract excessive immune responses and therefore possesses anti-inflammatory properties.

Press releases

IgM Concentrate: Remarkable relative reduction in morta...

16.03.2016, News

IgM Concentrate: Remarkable relative reduction in mortality of more than 50% in subgroup of patients - Favourable new data of phase II trial with IgM Concentrate in patients with severe ... [More]

Biotest's IgM Concentrate shows encouraging results in ...

30.06.2015, News

Biotest's IgM Concentrate shows encouraging results in life-threatening pneumonia - Phase II trial with IgM Concentrate completed in patients with severe community acquired ... [More]

Publications

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Schmiedl et al.: Safety of the IgM enriched immunoglobulin concentrate BT086 in healthy volunteers – results of a dose-escalating single dose phase I study. Br J Clin Pharmacol 2011, 72:1-46. Abstract 40
[ Link ]

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Schmiedl et al.: Evaluation of pharmacokinetics and safety of the IgM enriched immunoglobulin concentrate BT086 in healthy volunteers - results of a multiple dose phase I study. Br J Clin Pharmacol 2011, 72:1-46. Abstract 43
[ Link ]

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Welte et al.: Concept for a study design in patients with severe community-acquired pneumonia: A randomised controlled trial with a novel IGM-enriched immunoglobulin preparation – The CIGMA study. Respiratory Medicine , Volume 109 , Issue 6 , 758 - 767
[ Link ]

Clinical trials

Title

Indication

Status

 
IgM Concentrate (Study 982) Severe community acquired pneumonia Study completed

A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group, Adaptive Group-sequential Phase II Study, to Determine the Efficacy and Safety of BT086 as an Adjunctive Treatment in Severe Community Acquired Pneumonia (sCAP)

Link clinicaltrials.gov
 
IgM Concentrate (Study 970) Healthy volunteers Study completed

A prospective, randomised, placebo-controlled, and single-blind phase I study investigating safety, tolerability, and pharmacokinetic properties of IgM Concentrate BT086 in healthy subjects