Biotest AG: Interim analysis supports continuation of clinical phase IIa trial in Systemic Lupus Erythematosus
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). Biotest is currently preparing to continue with part 2 of study No. 990.
About BT-063 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.
About DSMB 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.
About Biotest 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.
IR contact Dr. Monika Buttkereit phone: +49-6103-801-4406 email: firstname.lastname@example.org
PR contact Dirk Neumüller phone: +49-6103-801-269 email: email@example.com
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.de
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201 Preference shares: securities' ID No. 522723; ISIN DE0005227235 Listing: Prime Standard Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hanover, Munich, Stuttgart
Disclaimer This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.
01.11.2016 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 include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de
Language: English Company: Biotest AG Landsteinerstraße 5 63303 Dreieich Germany Phone: 0 61 03 - 8 01-0 Fax: 0 61 03 - 8 01-150 E-mail: firstname.lastname@example.org Internet: http://www.biotest.de ISIN: DE0005227235, DE0005227201 WKN: 522723, 522720 Indices: SDAX Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange End of News DGAP News Service