Interim analysis supports continuation of clinical phase IIa trial in Systemic Lupus Erythematosus (Study No. 990)
- Category: Antibodies
- Published on Tuesday, 01 November 2016 09:25
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- Independent Data Safety Monitoring Board (DSMB) recommends to start part 2 of clinical study No. 990
- SMB did not identify any safety concerns
- SLE is an indication with remaining high medical need
DREIEICH, Germany I November 1, 2016 I Biotest AG announced today that the Data Safety Monitoring Board (DSMB) has recommended to continue as planned with part 2 of Biotest`s phase IIa clinical study of BT-063 for the treatment of systemic lupus erythematosus (SLE). This recommendation is based on an interim analysis after part 1 of study 990.
The clinical Study No. 990 is a double-blinded, placebo-controlled, multicenter trial. The primary goal of this clinical study is to investigate the safety and tolerability of the monoclonal antibody BT-063 in SLE patients versus placebo. As per protocol the study has 2 parts where an interim analysis was planned after finalisation of part 1 to decide on the continuation and the preferred dosage for part 2.
The DSMB did not identify any safety concerns in part 1 and therefore has recommended to continue with part 2 of this clinical study as planned in the study protocol. In order to keep the study blinded, the clinical study team, the clinical trial sites and the patients will have no access to results of the interim analysis until part 2 of the trial has been completed.
SLE is an autoimmune disease which may affect various organs. Chronic inflammation may occur resulting in potentially severe organ damage. Approximately 5 million people worldwide suffer from this autoimmune disease. Despite the use of current standard of care about 60% of SLE-patients continue to experience persistent symptoms. Up to date patients with SLE have only seen one new treatment for their disease in almost 60 years.
'With BT-063 Biotest pursues a completely new therapeutic approach to treat SLE patients. I am very impressed by the large range of mechanistic and pharmacological investigations conducted in parallel to the clinical study No. 990' says Prof. Dr. Ronald van Vollenhoven, Director of the Amsterdam Rheumatology and Immunology Center (ARC).
Biotest is currently preparing to continue with part 2 of study No. 990.
The humanized monoclonal antibody BT-063 specifically neutralizes interleukin 10 (IL-10), which plays a crucial role in the development of Systemic Lupus Erythematosus. With BT-063 Biotest pursues a completely new therapeutic approach to treat SLE patients.
The DSMB is comprised of independent medical experts and a statistician and was established by Biotest as part of the company's compliance with good clinical practice guidelines. At predetermined points in time the DSMB is responsible for the regular monitoring of patient safety and for conducting interim analyses of trial results. Raw data had been analysed, audited and provided to the DSMB by an independent unblinded statistician of the contract research organisation (CRO) managing the trial.
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 albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,400 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.