Development pipeline

Trimodulin (BT-588, IgM Concentrate)

Trimodulin is currently in clinical development for the treatment of patients with severe COVID-19 and for patients with severe community-acquired pneumonia (sCAP).

Trimodulin (IgM Concentrate) is an innovative immunoglobulin therapeutic derived from human blood plasma. Compared to conventional immunoglobulin G (IgG) preparations (IVIGs), Trimodulin contains relevant amounts of antibodies of classes M (IgM) and A (IgA) in addition to IgG.

Based on preclinical research, Trimodulin is thought to act through a number of mechanisms that interfere with pathological processes involved in respiratory failure, severe sepsis and multi-organ failure, eventually leading to death. Due to the variety of polyvalent antibodies present in Trimodulin, the patients’ impaired immune system is supported in various ways. The antibodies bind to different types of pathogens including viruses and bacteria as well as their toxins, and support their clearance by the immune system. Particularly the IgM component in Trimodulin might attenuate dysregulated immune responses and thus prevent the immune system from attacking the body’s own healthy tissue, e.g. the lungs. In this way, Trimodulin may help avoid complications and progression of disease.

Press releases

Biotest treats first COVID-19 patient with trimodulin

06.10.2020,

06.10.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services incl ... [More]

Biotest phase II study for the treatment of severe COVI...

03.09.2020,

03.09.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services incl ... [More]

Biotest submits phase II study with trimodulin for the ...

16.07.2020,

16.07.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services incl ... [More]

Biotest produces life-saving medicine derived from plas...

06.04.2020,

06.04.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services incl ... [More]

Trimodulin: concept for phase III study successfully co...

20.12.2017,

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 ... [More]

IgM Concentrate: Remarkable relative reduction in morta...

16.03.2016,

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 Community Acqui ... [More]

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

30.06.2015,

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

Publications

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Duerr et al.: The novel polyclonal Ab preparation trimodulin attenuates ex vivo endotoxin-induced immune reactions in early hyperinflammation. Innate Immunity 2019, 25(6), 374–388.
[ 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 2015, Volume 109, Issue 6, 758 – 767.
[ Link ]

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Welte et al., Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia: a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study). Intensive Care Med. 2018, 44: 438–448.
[ 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 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 ]

Clinical trials

Title

Indication

Status

 
Trimodulin (Study 998, ESsCOVID) Severe COVID-19 Recruiting

A randomized, placebo-controlled, double-blind, multi-center, phase II trial investigating the efficacy and safety of trimodulin (BT588) as add-on therapy to standard of care in adult subjects with severe COVID-19.

Link clinicaltrials.gov
 
Trimodulin (Study 982; CIGMA) Severe community acquired pneumonia Study completed

A prospective 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
 
Trimodulin (Study 970) Healthy subjects Study completed

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