Biotest AG: Phase IIa study demonstrates favorable safety and tolerability profile for Biotest's monoclonal antibody BT-063 for treatment of systemic lupus erythematosus (SLE)
News: Biotest AG / Key word(s): Research Update
Phase IIa study demonstrates favorable safety and tolerability profile for Biotest's monoclonal antibody BT-063 for treatment of systemic lupus erythematosus (SLE)
- Study meets primary endpoint for safety and tolerability
- First signs of efficacy shown by early and sustained treatment effects
- Potential of BT-063 for the treatment of Systemic Lupus Erythematosus (SLE) supported by key opinion leaders
The clinical Study No. 990 was a Phase IIa, double-blind, placebo-controlled, multicenter study. The overall primary goal of this clinical study was to investigate the safety and tolerability of the monoclonal antibody BT-063 in SLE patients versus placebo. The study was divided into 2 parts. An interim analysis performed after Part I allowed the increase of the dosage from 50mg to 100mg.
The primary composite endpoint was the incidence of adverse events (including Serious Adverse Events [SAEs] and AEs leading to discontinuation) and changes in safety related parameters such as safety lab from baseline through week 14 (after 12 weeks of treatment), respectively.
Secondary endpoints included evaluation of efficacy after 12 weeks of treatment with BT-063 versus placebo as assessed by various disease activity indices including subject-reported outcomes; determination of pharmacokinetics and immunogenicity of BT-063.
The study achieved its primary endpoint, demonstrating a favorable overall safety profile with BT-063 plus current standard of care.
Data did also demonstrate first signs of efficacy shown by early and sustained treatment effects among several patients as assessed by different disease activity indices.
'The approach taken with BT-063 builds on solid insights into the autoimmune disease process and the role that the signaling substance interleukin 10 (IL-10) IL-10 plays in this' says Professor Dr Ronald van Vollenhoven, Director of the Amsterdam Rheumatology and Immunology Center (ARC). 'The results that have been achieved in the recently completed study confirm the feasibility of this approach. The results also suggest that through diligent further clinical investigation it may be possible to identify the optimal patient population to benefit potentially from this treatment'.
The Company will undertake a review of the study's full dataset and will work with its key opinion leaders to determine the optimal next steps. We look forward to share the complete data with the scientific community in the future.
About systemic lupus erythematosus (SLE)
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
|Phone:||0 61 03 - 8 01-0|
|Fax:||0 61 03 - 8 01-150|
|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|