Development pipeline

Trimodulin (BT-588, IgM Concentrate)

Trimodulin is an innovative polyvalent antibody composition, purified from human plasma. In comparison to standard IgG preparations (IVIG), trimodulin contains relevant amounts of IgM and IgA in addition to IgG.

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

Research so far has shown that trimodulin could interfere with a number of mechanisms involved in pathological processes that would otherwise lead to respiratory failure, sepsis, multi-organ failure and finally to death of the patient. Due to the large variety of polyvalent antibodies present in trimodulin, the impaired immune system is supported in various ways. Particularly the IgM component in trimodulin can reduce dysregulated immune responses, preventing the immune system to attack host tissues, in this case the lung. The polyvalent antibodies also bind to various types of pathogens including viruses and bacteria as well as their toxins and support their clearance by the immune system. In this way, trimodulin may prevent progression of disease, including the need for invasive mechanical ventilation and other intensive care procedures.

Press releases

Trimodulin does not reach the primary endpoint in the p...

13.08.2021,

13.08.2021 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 proves the mode of action of trimodulin for the...

03.08.2021,

03.08.2021 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 successfully completes recruitment for its clin...

02.06.2021,

02.06.2021 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 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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Bohländer et al., Immunomodulation: Immunoglobulin Preparations Suppress Hyperinflammation in a COVID-19 Model via FcgRIIA and FcaRI. Front. Immunol. (2021) 12:700429. doi: 10.3389/fimmu.2021.700429.
[ Link ]

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Schmidt et al., The Dual Role of a Polyvalent IgM/IgA-Enriched Immunoglobulin Preparation in Activating and Inhibiting the Complement System, Biomedicines (2021) 9, 817.
[ Link ]

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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., 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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Shmygalev et al., IgM-enriched solution BT086 improves host defense capacity and energy store preservation in a rabbit model of endotoxemia. Acta Anaesthesiologica Scandinavica 60 (2016) 502–512. doi: 10.1111/aas.12652.
[ 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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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 Study completed

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