Development pipeline

IgG Next Generation

IgG Next Generation is a newly developed polyvalent immunoglobulin preparation for intravenous administration from human plasma for the treatment of immunodeficiencies and autoimmune diseases.

IgG Next Generation will be submitted for approval in several European countries and USA. Clinical development is about to be completed in two pivotal trials: phase III Study No. 991 for the treatment of patients with primary immunodeficiencies (PID) and Phase III Study No. 992 for the treatment of patients with immune thrombocytopenia (ITP). Study No. 991 has completed enrollment; the one-year treatment phase will continue until the end of Q1 2020. Study No. 992 has already been completed and evaluated. The results confirm the expectations regarding efficacy and safety of the drug.

Press releases

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]

Clinical trials

Title

Indication

Status

 
IgG Next Generation (Study 991) Primary Immune Deficiency (PID) Study ongoing

An open label, prospective, multicenter phase III study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID)

Link clinicaltrialsregister.eu
 
IgG Next Generation (Study 992) Idiopathic Thrombocytopenic Purpura (ITP) Study completed

An open label, prospective, randomized, multicenter phase III study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)

Link clinicaltrialsregister.eu