Marburg, Germany, 27 February 2012
- sterna biologicals completes first-in-man study of SB010, an inhaled GATA-3 antagonist for the treatment of moderate to severe Th2-driven asthma
- SB010 was safe and well-tolerated across all dose levels
sterna biologicals GmbH & Co. KG (“sterna biologicals”) is pleased to announce successful completion of a Phase I clinical trial of its novel inhaled GATA-3 antagonist SB010 for the treatment of moderate to severe Th2-driven asthma.
The trial was a randomised, double-blind, placebo-controlled assessment of safety and tolerability of single ascending doses of SB010 in 48 male subjects and conducted by CRS Clinical Research Services Mannheim GmbH in Mannheim, Germany (“CRS”). Six dose levels were evaluated, up to and including 40mg. Adverse events were limited, unrelated to SB010 or its specific mechanism of action, and fully resolved by the end of the in-house study period.
Dr. Joachim Bille, Managing Director of sterna biologicals, commented:
“The results from our first Phase I trial confirm the favourable results from our pre-clinical toxicological studies in animals. We have already filed two further Phase I trials with regulatory agencies and intend to complete our entire Phase I programme for SB010 by Q3 2012. Sterna biologicals is on track to evaluate SB010 in a first Phase IIa proof-of-concept trial in asthmatic patients as soon as possible thereafter.”
The two remaining Phase I trials of SB010 are:
- a multiple ascending dose study in 36 male subjects over thirteen days with b.i.d-dosing, to be conducted by CRS in Mannheim, Germany
- a single ascending dose study in 24 stable asthmatic patients to assess in particular hyperresponsiveness of the airways, to be conducted by the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) in Hannover, Germany
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.