Biotest AG: Interim analysis supports continuation of clinical phase IIa trial in Systemic Lupus Erythematosus (Study No. 990)
News: Biotest AG / Key word(s): Research Update / PRESS RELEASE Interim analysis supports continuation of clinical phase IIa trial in Systemic Lupus Erythematosus (Study No. 990) - Independent Data Safety Monitoring Board (DSMB) recommends to start part 2 of clinical study No. 990 - DSMB did not identify any safety concerns - SLE is an indication with remaining high medical need Dreieich, 1 November 2016. 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). About BT-063 About DSMB About Biotest IR contact PR contact Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.de Ordinary shares: securities' ID No. 522720; ISIN DE0005227201 Disclaimer 2016-11-01 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
Language: | English | |
Company: | Biotest AG | |
Landsteinerstraße 5 | ||
63303 Dreieich | ||
Germany | ||
Phone: | 0 61 03 - 8 01-0 | |
Fax: | 0 61 03 - 8 01-150 | |
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ISIN: | DE0005227235, DE0005227201 | |
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