Biotest Achieves Important Clinical Milestone for IgG Next Generation
- Category: Antibodies
- Published on Thursday, 05 September 2019 10:55
- Hits: 588
- Phase III study in Primary Immune Thrombocytopenia (ITP) completed, data evaluation in progress, promising results
- The study is one of two pivotal phase III studies in the clinical program for IgG Next Generation, a novel development of our polyvalent immunoglobulin G
- Clinical development in line with progress of new manufacturing facility Biotest Next Level
DREIEICH, Germany I September 05, 2019 I Biotest AG today announced the completion of study no. 992 - a phase III study investigating IgG Next Generation as immunomodulatory therapy in patients diagnosed with chronic primary immune thrombocytopenia (ITP). ITP is an autoimmune disease in which the immune system attacks and destroys the body's own platelets, the cells that prevent bleeding in blood vessels and facilitate clotting. In the study 34 patients were treated. The evaluation of data is ongoing. First results confirm efficacy and safety expectations.
"We are very pleased to have completed the first key program milestone in the development plan for our new intravenous immunoglobulin. Final results are expected end of Q4/2019", said Jörg Schüttrumpf, Head of Corporate R&D. "This product will be a new generation of our polyvalent immunoglobulin portfolio."
Study no. 992 is one of two pivotal phase III studies in the clinical program for IgG Next Generation. After finalization of the second trial with IgG Next Generation in Primary Immunodeficiency (PID), both studies will be submitted together to the health authorities. Following approval, IgG Next Generation can be marketed in additional established indications of intravenous immunoglobulins, in particular replacement therapy in secondary immunodeficiency disease (e.g. chronic lymphocytic leukaemia, multiple myeloma, after allogeneic haematopoietic stem cell transplantation) and as immunomodulatory therapy in Guillain Barré Syndrome (GBS), Kawasaki disease, Multifocal motor neuropathy (MMN) and Chronic inflammatory demyelinating polyneuropathy (CIDP). The sales potential of immunoglobulins in immunomodulatory diseases in Europe is in the range of EUR1.3 billion, 7% thereof in ITP itself.
IgG Next Generation is manufactured using an innovative production process and will be the master product of the new Biotest Next Level manufacturing facility currently under construction. This new manufacturing facility, which uses state of the art technologies, represents Biotest's latest commitment to the global immunoglobulin markets.
About study no. 992
Study no. 992 is a phase III, open label, prospective, multicentre trial investigating the clinical efficacy and safety of IgG Next Generation as immunomodulatory therapy in adult patients diagnosed with chronic primary immune thrombocytopenia (ITP) at high risk of bleeding or before surgery to correct the platelet count.
Patients are randomized in a 1:1 ratio to receive either 1 g/kg bodyweight per day for 2 consecutive days or 0.4 g/kg bodyweight per day on 5 consecutive days. The primary objective of this study is to determine the percentage of patients who achieve response. A response is defined as a platelet count of >=30×109/L and at least a 2-fold increase of the baseline count and the absence of bleeding.
More information about the study design can be found at www.clinicaltrialsregister.eu (EudraCT Number: 2015-003653-17)
About Primary Immune Thrombocytopenia (ITP)
Primary immune thrombocytopenia - also formerly known as idiopathic thrombocytopenic purpura or immune thrombocytopenic purpura - is an autoimmune-mediated condition, in which autoantibodies with specificity for one or more platelet membrane glycoproteins (GPs), binds to circulating platelet membranes. The coating of platelets with autoantibodies renders them susceptible for elimination from the blood.
Because patients suffering from ITP have a low platelet count, they may bruise easily and experience bleeding that is hard to stop. ITP is a rare blood disorder that affects about five to nine in 100,000 adults each year.
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition, Biotest develops monoclonal antibodies in certain cancer indications and in systemic lupus erythematosus, an autoimmune disease, which are produced by recombinant technologies. Biotest has more than 1,700 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.