Marburg, Germany, 07 November 2011
sterna biologicals GmbH & Co. KG ("sterna biologicals") is pleased to announce first dosing of its novel inhaled GATA-3 antagonist SB010 for the treatment of moderate to severe Th2-driven asthma in a phase I clinical trial. The trial is a randomised, double-blind, placebo-controlled assessment of safety and tolerability of single ascending doses of SB010 in 48 male subjects conducted by CRS Clinical Research Services Mannheim GmbH in Mannheim, Germany.
Dr Joachim Bille, Managing Director of sterna biologicals, commented:
"sterna biologicals, its employees, and our partners have worked hard over the past years to bring an exciting novel drug candidate for the treatment of asthma into clinical trials. Our phase I trial marks the first time a DNAzyme is being evaluated in clinical trials and could open up a new class of therapeutic agents. We are looking forward to first clinical data in early 2012 and intend to swiftly move SB010 into a proof-of-concept trial in asthmatic patients."
sterna biologicals' drug candidate SB010 is an inhaled DNAzyme-based GATA-3 antagonist. GATA-3 is the master transcription factor in regulating Th2-driven inflammatory diseases such as asthma. It is generally accepted that GATA-3 is necessary and sufficient for the production of key cytokines interleukin (IL)-4, IL- 5, and IL-13, which cause inflammation. In pre-clinical development, SB010 significantly reduced expression of these cytokines and was safe and well-tolerated in toxicological studies with negligible side-effects. DNAzymes are single-stranded DNA molecules comprising a catalytic domain flanked by two binding domains. The binding domains attach to a specific sequence of targeted mRNA (antisense), in case of SB010 GATA-3 mRNA. After binding to the target, the catalytic domain then cleaves the mRNA, thereby inhibiting relevant cytokine expression.
Asthma is a major chronic inflammatory disease of the airways affecting an estimated 300 million people worldwide. In OECD countries, prevalence is around 10% and increasing, with greater than average prevalence amongst women, children, and the elderly.