Marburg, Germany, 14 May 2014
sterna biologicals GmbH & Co. KG ("sterna biologicals") announced today that Prof Harald Renz will present key results of the recently completed Phase IIa clinical trial of SB010, an inhaled first-in-class GATA-3 antagonist for the treatment of Th2-driven asthma, at the upcoming American Thoracic Society (ATS) 2014 International Conference being held in San Diego, CA, 16 to 21 March.
As previously announced, sterna biologicals successfully completed a Phase IIa proof-of-concept trial with significant clinical effects in both the early and late phase asthmatic response to specific allergen challenge. The study – a randomised, double-blind, parallel group, multi-centre clinical trial – was designed to establish efficacy of SB010 in improving lung function (FEV1) as measured by the area under the FEV1 curve (AUC) compared to placebo treatment.
SB010 attenuated the decline in mean AUC in the late phase asthmatic response by 34% compared to a 1% worsening in the placebo group (p=0.02). SB010 also attenuated the decline in mean AUC in the early phase asthmatic response by 11% compared to a 10% worsening in the placebo group (p=0.03).
The presentation entitled "DNAzymes in the Treatment of Asthma" will take place on 20 May 2014 as part of session C88: "Novel Insights into Targets and Treatments Opportunities in Asthma" at approximately 3:40pm PT in Room 6 D-E.
sterna biologicals' drug candidate SB010 is a first-in-class inhaled 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 a comprehensive Phase I clinical programme. SB010 demonstrated strong clinical effects in a Phase IIa proof-of-concept trial. 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, 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.